Last update 24 Dec 2024

Diazepam

Last update 24 Dec 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryThe pharmacological agent Diazepam, a preeminent GABAA receptor agonist that was granted approval on November 15, 1963, by Waylis, is an efficacious medication used to mitigate a range of conditions, including muscle spasticity, alcohol abstinence, anxiety disorders, and epilepsy. The intricate chemical composition of this pharmacological agent is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. The multifaceted mechanism by which Diazepam operates is by potentiating the effects of gamma-Aminobutyric acid (GABA), an inhibitory neurotransmitter, thereby producing a tranquilizing effect on the body. The pervasiveness of Diazepam within the fields of psychiatry and neurology is incontrovertible, and its usage has become indispensable in the management of a broad spectrum of medical conditions.

Drug Type

Small molecule drug

Synonyms

7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one, DBF, DBSF

+ [35]

Target

GABAA receptor

Mechanism

GABAA receptor agonists(Gamma-aminobutyric acid A receptor agonists)

Therapeutic Areas

Nervous System DiseasesCardiovascular DiseasesSkin and Musculoskeletal Diseases+ [1]

Active Indication

Organophosphate PoisoningFebrile Seizures Associated With Afebrile SeizuresSeizures+ [9]

Inactive Indication

Acute repetitive seizure

Originator Organization

Waylis Therapeutics LLC

Active Organization

Maruishi Pharmaceutical Co., Ltd.

Takeda Pharmaceutical Co., Ltd.

Chengdu First Pharmaceutical Co. Ltd.

+ [7]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

US (15 Nov 1963),

Alcohol AbstinenceAnxiety DisordersEpilepsy+ [1]

RegulationFast Track (US), Orphan Drug (US)

Structure

Molecular FormulaC16H13ClN2O

InChIKeyAAOVKJBEBIDNHE-UHFFFAOYSA-N

CAS Registry439-14-5

121

Clinical Trials associated with Diazepam

ChiCTR2400091512 / SuspendedPhase 4IIT

A Real World Study on the Safety and Efficacy of Diazepam Nasal Spray in Children with Epilepsy

Start Date01 Nov 2024

Sponsor / Collaborator-

NCT06293989 / Not yet recruitingPhase 3

Efficacy and Safety of Intravenous Diazepam Given at 2 Different Doses Compared to Placebo in Acute Peripheral Vertigo: A Randomized Controlled Double Blinded Study

This is prospective, randomised double-blind study that will be conducted in the emergency department of 3 university hospitals (FB Monastir, Sahloul Sousse, and FH Sousse) to compare the efficacy of two doses of diazepam (Valium®) and placebo for the relief of acute periphery vertigo in the ED

Start Date01 May 2024

Sponsor / Collaborator

Université de Monastir

NCT06346262 / RecruitingPhase 4IIT

Seizure Rescue Medication (RM) as Part of a Comprehensive Epilepsy Self-management Package of Care

This study will be done in two phases. Using stakeholder input (community advisory board (CAB)), the study team will adapt the SMART program to incorporate education and self-management support for use of Rescue Medication (RM) to manage seizure occurrence among Persons With Epilepsy (PWE) who have repetitive seizures. Additional content/support materials, pending input stakeholder might include posters/hand-outs that present information on the use of RM in a way that is engaging and salient to PWE. It is expected that participants will be in Phase 1 for about 3 months and participate in the CAB 2 or 3 times via zoom for 60-90 minutes/meeting. The advisory board will provide input on needed refinement of an adapted version of SMART based on their individual experiences. It is anticipate the total time commitment to be no more than 6 hours over 3 months, spread out over 2-3 meetings with review of materials possible in between meetings.
Phase 2: The investigators will use a 6-month prospective trial design to test engagement with and effects of SMART-RM among approximately 35 adult (≥ 18 years) PWE who have repetitive seizures.

Start Date05 Mar 2024

Sponsor / Collaborator

University Hospitals Cleveland Medical Center

100 Clinical Results associated with Diazepam

100 Translational Medicine associated with Diazepam

100 Patents (Medical) associated with Diazepam

21,299

Literatures (Medical) associated with Diazepam

01 Apr 2025·TALANTA

A “four-in-one” immunochromatographic strip for multi-readout detection of diazepam in lake water and fish via nanozyme-mediated colorimetric, catalytic, and photothermal activities

Article

Author: Shi, Qingge ; Zhang, Fuyuan ; Liu, Hangrui ; Liu, Weihua ; Wang, Xianghong ; Sang, Yaxin ; Wang, Jing

The presence of psychotropic drugs (PDs) in aquatic ecosystems represents an increasing environmental problem, posing a serious threat to human health and aquatic organisms. Lateral flow immunoassays (LFIA) have been widely used in the detection of PD contaminants. However, maintaining signaling tag reporting activity and achieving LFIA's multi-readout capability remain significant challenges to meeting a range of detection scenarios. Here, a rapid multifunctional LFIA has been developed for detecting diazepam (DAP), an emerging environmental and food safety PD contaminant, in lake water and fish samples. Copper hexacyanoferrate nanoparticles doped with Au and Pt (AuPt@Cu-HCF) were designed and manufactured as a multi-signal reporter with exceptional photothermal conversion efficiency and peroxidase-like enzymatic activity. This study integrates the colorimetric, photothermal, catalytic colorimetric, and catalytic photothermal effects of the AuPt@Cu-HCF nanozyme to form a "four-in-one" multi-readout LFIA. The multifunctional detection approach achieved four different detection signal outputs for DAP, with detection limits of 0.82 ng/mL, 12.82 pg/mL, 12.26 pg/mL, and 4.43 pg/mL for the basic colorimetric, photothermal, catalytic colorimetric, and colorimetric photothermal readout modes, respectively. This quadruplex-functional LFIA offers four different options with varying sensitivities and detection ranges, suitable for various application scenarios. It also allows multiple verifications for a single sample, enhancing detection accuracy.

01 Mar 2025·BEHAVIOURAL BRAIN RESEARCH

Anxiogenic-like effects of coumarin, possibly through the GABAkine interaction pathway: Animal studies with in silico approaches

Article

Author: Emon, Md ; Coutinho, Henrique D M ; Bappi, Mehedi Hasan ; Ripu, Tawfik Rakaiyat ; Ansari, Siddique Akber ; Ahmmed, Md Shakil ; Prottay, Abdullah Al Shamsh ; Islam, Muhammad Torequl ; Sarwar, Md Nazim ; Emamuzzaman ; Rahman, Towfiqur

BACKGROUND:

Anxiety disorder is the most common mental illness and a major contributor to impairment. Thus, there is an urgent need to find novel lead compounds to mitigate anxiety. It is widely recognized that the neurobiology of anxiety-related behavior involves GABAergic systems.

OBJECTIVES:

This research aimed to examine the anxiogenic action of coumarin (CMN), a natural benzopyrone derived from plants, and determine its underlying mechanism through in vivo and in silico investigations.

METHODS:

This was accomplished by using a variety of behavioral procedures, including open field, swing, hole cross, and light-dark tests, on male and female Swiss albino mice that had been orally administered three experimental doses of CMN (1, 2, and 4 mg/kg). The CMN group was also examined with the GABA_A receptor agonist diazepam (DZP, 2 mg/kg) and flumazenil antagonist (FLU, 0.1 mg/kg). Furthermore, CMN and standards were subjected to a molecular docking analysis to determine their binding affinities for the GABA_A receptor subunits (α1, α4, β2, γ2, and δ). Several software programs were used to visualize the ligand-receptor interaction and analyze the pharmacokinetic profile.

RESULTS:

Compared to typical treatments, our results show that CMN (1 mg/kg) significantly (p < 0.05) increases the locomotor activity of animals. Furthermore, CMN exerted the highest binding affinity (-6.5 kcal/mol) with the GABA-α1 receptor compared to conventional DZP. Along with FLU, CMN displayed several hydrophobic and hydrogen bonds with GABA_A receptor subunits. The pharmacokinetic and drug-like properties of CMN are also remarkable. In animal studies, CMN worked synergistically with FLU to provide anxiogenic-like effects.

CONCLUSION:

We conclude that, based on in vivo and in silico data, CMN, alone or in combination with FLU, may be employed in future neurological clinical studies. However, further research is needed to confirm this behavioral activity and elucidate the possible mechanism of action.

01 Feb 2025·BEHAVIOURAL BRAIN RESEARCH

An unescapable looming threat paradigm for assessing anxiety-like responses in rats

Article

Author: Malkova, Ludise ; Aguilar, Brittany L ; Forcelli, Patrick A ; Toib, Jonathan

Rapidly approaching visual stimuli (i.e. looming objects) are known to evoke unconditioned defense responses across species. In rodents, this threat reactivity repertoire includes freezing and fleeing behavior. Although components of the circuitry underlying unconditioned response to a looming threat have been elucidated, both a temporal characterization and drug effects on the freezing response have not yet been reported. Here, we describe a modified version of a looming threat task in which no escape route is available. In this task, we observed unconditioned freezing prior to, during, and after exposure to a looming threat stimulus. In Long Evans (LE) and Sprague-Dawley (SD) rats, we report looming stimulus-specific freezing response. We further explored the specificity and pharmacosensitivity of this response in male and female LE rats. Administration of a GABA-A receptor negative allosteric modulator (FG-7142) did not re-establish freezing in habituated animals; however, administration of a GABA-A receptor positive allosteric modulator (diazepam) in naïve LEs significantly reduced freezing during the post-looming period in a sex-dependent manner. Presentation of an unescapable looming stimulus results in freezing that extends beyond the acute threat exposure. Because freezing responses outlast the initial threat, and display only modest sensitivity to conventional anxiolytic therapy, this may represent a platform for screening agents in treatment-refractory anxiety.

172

News (Medical) associated with Diazepam

19 Dec 2024

·investors.aquestive.com

Aquestive Therapeutics Receives U.S. FDA Orphan Drug Exclusivity for Libervant® (diazepam) Buccal Film in Pediatric Patients with Seizure Clusters Ages Two to Five

WARREN, N.J., Dec. 19, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced the U.S. Food and Drug Administration (FDA) has granted seven years of orphan drug exclusivity (ODE) to Libervant® (diazepam) Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy between two to five years of age. On April 26, 2024, Libervant® (diazepam) Buccal Film was approved for pediatric patients between two to five years of age. FDA granted ODE based on their assessment that Libervant’s buccal route of administration provides a major contribution to patient care over the rectal route of administration by providing a significantly improved ease of use. “As the first and only orally administered rescue therapy for this patient population, Libervant provides patients and caregivers an important, non-invasive treatment option,” said Daniel Barber, Chief Executive Officer of Aquestive. “We remain focused on ensuring that healthcare providers are educated on the benefits of Libervant and patients and caregivers within the indicated population have the best possible access to the product.” The FDA’s Office of Orphan Products Development grants orphan designation status to drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the U.S. The designation provides certain benefits, including financial incentives, to support clinical development and the potential for up to 7 years of market exclusivity in the U.S. upon regulatory approval. Libervant was originally granted Orphan Drug Designation on November 10, 2016 and the ODE now granted to Libervant for patients ages two to five extends to April of 2031. Libervant® (diazepam) Buccal Film is the first and only FDA approved orally administered rescue product for the treatment of seizure clusters in patients with epilepsy between two to five years of age. About Libervant Libervant is a buccally, or inside of the cheek, administered film formulation of diazepam, a benzodiazepine intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy two to five years of age. Aquestive developed Libervant as an alternative to the device-based products currently available for patients with refractory epilepsy, including rectal gel and nasal spray products. The FDA granted tentative approval in August 2022 for Libervant for treatment of these epilepsy patients 12 years of age and older, with U.S. market access for Libervant for this age group of patients subject to the expiration of the existing orphan drug market exclusivity of a previously FDA approved drug scheduled to expire in January 2027. The FDA approval for U.S. market access received in April 2024 for Libervant is for these epilepsy patients between two and five years of age. Important Safety Information Do not give Libervant® to your child if your child is allergic to diazepam or any of the ingredients in Libervant or has an eye problem called acute narrow angle glaucoma. What is the most important information I should know about Libervant? Libervant is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma, and death. Get emergency help right away if any of the following happens: shallow or slowed breathing, breathing stops (which may lead to the heart stopping), excessive sleepiness (sedation). shallow or slowed breathing, breathing stops (which may lead to the heart stopping), excessive sleepiness (sedation). Do not allow your child to drive a motor vehicle, operate heavy machinery, or ride a bicycle until you know how taking Libervant with opioids affects your child. Risk of abuse, misuse, and addiction. Libervant is used in children 2 to 5 years of age. The unapproved use of Libervant has a risk for abuse, misuse, and addiction, which can lead to overdose and serious side effects including coma and death. Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including diazepam (the active ingredient in Libervant). These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your child’s healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects. Your child can develop an addiction even if your child takes Libervant as prescribed by your child’s healthcare provider. Give Libervant exactly as your child’s healthcare provider prescribed. Do not share Libervant with other people. Keep Libervant in a safe place and away from children. Physical dependence and withdrawal reactions. Libervant is intended for use if needed in order to treat higher than usual seizure activity. Benzodiazepines, including Libervant, can cause physical dependence and withdrawal reactions, especially if used daily. Libervant is not intended for daily use. Do not suddenly stop giving Libervant to your child without talking to your child’s healthcare provider. Stopping Libervant suddenly can cause serious and life-threatening side effects, including, unusual movements, responses, or expressions, seizures that will not stop (status epilepticus), sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, homicidal thoughts, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. Call your child’s healthcare provider or go to the nearest hospital emergency room right away if your child gets any of these symptoms. Some people who suddenly stop benzodiazepines have symptoms that can last for several weeks to more than 12 months including, anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping, feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning, or prickling feeling in your hands, arms, legs or feet, and ringing in your ears. Physical dependence is not the same as drug addiction. Your child’s healthcare provider can tell you more about the differences between physical dependence and drug addiction. Do not give your child more Libervant than prescribed or give Libervant more often than prescribed. Your child can develop an addiction even if your child takes Libervant as prescribed by your child’s healthcare provider. Give Libervant exactly as your child’s healthcare provider prescribed. Do not share Libervant with other people. Keep Libervant in a safe place and away from children. Do not suddenly stop giving Libervant to your child without talking to your child’s healthcare provider. Stopping Libervant suddenly can cause serious and life-threatening side effects, including, unusual movements, responses, or expressions, seizures that will not stop (status epilepticus), sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, homicidal thoughts, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. Call your child’s healthcare provider or go to the nearest hospital emergency room right away if your child gets any of these symptoms. Some people who suddenly stop benzodiazepines have symptoms that can last for several weeks to more than 12 months including, anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping, feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning, or prickling feeling in your hands, arms, legs or feet, and ringing in your ears. Physical dependence is not the same as drug addiction. Your child’s healthcare provider can tell you more about the differences between physical dependence and drug addiction. Libervant can make your child sleepy or dizzy and can slow your child’s thinking and motor skills. Do not allow your child to drive a motor vehicle, operate machinery, or ride a bicycle until you know how Libervant affects your child. Do not give other drugs that may make your child sleepy or dizzy while taking Libervant without first talking to your child’s healthcare provider. When taken with drugs that cause sleepiness or dizziness, Libervant may make your child’s sleepiness or dizziness much worse. Like other antiepileptic medicines, Libervant may cause suicidal thoughts or actions in a small number of people, about 1 in 500. Call a healthcare provider right away if your child has any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying new or worse depression feeling agitated or restless trouble sleeping (insomnia) acting aggressive, being angry or violent other unusual changes in behavior or mood attempts to commit suicide new or worse anxiety or irritability an extreme increase in activity and talking (mania) new or worse panic attacks acting on dangerous impulses Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your child’s healthcare provider as scheduled. Call your child’s healthcare provider between visits as needed, especially if you are worried about symptoms. Suicidal thoughts or actions can be caused by things other than medicines. If your child has suicidal thoughts or actions, your child’s healthcare provider may check for other causes. thoughts about suicide or dying new or worse depression feeling agitated or restless trouble sleeping (insomnia) acting aggressive, being angry or violent other unusual changes in behavior or mood attempts to commit suicide new or worse anxiety or irritability an extreme increase in activity and talking (mania) new or worse panic attacks acting on dangerous impulses What are the possible side effects of Libervant? The most common side effects of Libervant are sleepiness and headache. These are not all the possible side effects of Libervant. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information about Libervant, talk to your doctor, and see Product Information: Medication Guide and Instructions For Use. About Aquestive Therapeutics Aquestive is a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies. We are developing orally administered products to deliver complex molecules, providing novel alternatives to invasive and inconvenient standard of care therapies. Aquestive has five commercialized products marketed by the Company and its licensees in the U.S. and around the world, and is the exclusive manufacturer of these licensed products. The Company also collaborates with pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm®, and has proven drug development and commercialization capabilities. Aquestive is advancing a late-stage proprietary product candidate for the treatment of severe allergic reactions, including anaphylaxis, and an earlier stage epinephrine prodrug topical gel for various dermatology conditions. For more information, visit Aquestive.com and follow us on LinkedIn. Forward-Looking Statement This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,” “will,” or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the potential benefits Libervant could bring to pediatric patients aged 2 to 5. These forward-looking statements are based on the Company’s current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks associated with the Company’s distribution work for Libervant, including any delays or changes to the timing, cost and success of its distribution activities and expansion of market access to patients for Libervant; risk of litigation brought by third parties relating to overcoming their orphan drug exclusivity of an FDA approved product for these pediatric epilepsy patients; risk of the success of any competing products; risk inherent in commercializing a new product (including technology risks, financial risks, market risks and implementation risks, and regulatory limitations); risk of the rate and degree of market acceptance of Libervant; risk of insufficient capital and cash resources, including insufficient access to available debt and equity financing and revenues from operations, to satisfy all of the Company’s short-term and longer term liquidity and cash requirements and other cash needs, at the times and in the amounts needed, including to fund commercialization activities relating to Libervant; risk that our manufacturing capabilities will be insufficient to support demand for Libervant; risk of eroding market share for Suboxone® and risk as a sunsetting product, which accounts for the substantial part of our current operating revenue; risk of the size and growth of our product markets; risks of compliance with all FDA and other governmental and customer requirements for our manufacturing facilities; risks associated with intellectual property rights and infringement claims relating to the Company's products; risk of unexpected patent developments; uncertainties related to general economic, political (including the wars in Israel and Ukraine and other acts of war and terrorism), business, industry, regulatory, financial and market conditions and other unusual items; and other risks and uncertainties affecting the Company described in the “Risk Factors” section and in other sections included in the Company’s 10-K for the year ended December 31, 2023, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K filed with the U.S. Securities and Exchange Commission. Given those uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date made. All subsequent forward-looking statements attributable to the Company or any person acting on its behalf are expressly qualified in their entirety by this cautionary statement. The Company assumes no obligation to update forward-looking statements after the date of this press release whether as a result of new information, future events or otherwise, except as may be required by applicable law. All other registered trademarks referenced herein are the property of their respective owners. Pharmfilm®, Libervant® and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc. All other registered trademarks referenced herein are the property of their respective owners. Investor Contact: Brian Korb astr partners brian.korb@astrpartners.com

Drug ApprovalOrphan Drug

06 Dec 2024

·www.prnewswire.com

Jazz Pharmaceuticals to Showcase New Real-World Evidence Reinforcing Epidiolex® (cannabidiol) Benefits and Broad-Spectrum Efficacy in Treatment-Resistant Epilepsies at the American Epilepsy Society 2024 Annual Meeting

Data from nine abstracts to be presented, including first data from the EpiCom Trial, a prospective evaluation of behavioral outcomes in patients with tuberous sclerosis complex, which suggests improvements in severity of behavioral symptoms Real-world data from the BECOME (BEhavior, COgnition and More with Epidiolex®) surveys, which show outcomes reported by long-term care facility nurses and tuberous sclerosis complex caregivers For U.S. media and investors only DUBLIN, Dec. 6, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced nine company-sponsored Epidiolex® (cannabidiol) posters are being presented at the American Epilepsy Society (AES) 2024 Annual Meeting, being held December 6-10 in Los Angeles, California. Data presented at the meeting includes updated analyses of real-world data from the BECOME-TSC (BEhavior, COgnition, and More with Epidiolex) caregiver survey, which characterizes and quantifies seizure and non-seizure outcomes in patients with epilepsy and tuberous sclerosis complex (TSC) treated with Epidiolex. An additional presentation showcases data from the BECOME-LTC survey, which evaluated the perspectives of nurses who care for patients with epilepsy in long-term care (LTC) facilities and group homes, reporting improvements in seizure frequency and in certain non-seizure outcomes associated with Epidiolex treatment. Further, the first presentation of data from the EpiCom trial, a prospective, interventional trial evaluating the impact of adjunctive Epidiolex on TSC-associated neuropsychiatric disorders (TAND), revealed improvements in behavioral symptom severity following treatment initiation. "Our real-world data presentations at AES 2024, including novel findings from the BECOME-LTC, BECOME-TSC and EpiCom studies, demonstrate the meaningful impact of Epidiolex in the treatment of patients with rare epilepsies," said Sarah Akerman, MD, head of neuroscience global medical and scientific affairs of Jazz Pharmaceuticals. "These findings increase our understanding of Epidiolex's benefits beyond seizure control, addressing unmet needs across a range of epilepsy syndromes for people living with rare epilepsies and demonstrating reproducibility and consistency of effect across different populations." Data highlights include: A prespecified three-month analysis of the EpiCom trial reporting TSC-associated neuropsychiatric disorders (TAND)-associated outcomes demonstrated improvements after initiating adjunctive Epidiolex treatment in the severity of behavioral problems in patients with TSC as reported by the TAND Self-Report Quantified Checklist and Aberrant Behavior Checklist. Two updated analyses of real-world outcomes from the BECOME-TSC study showed that, of 55 caregivers who completed the survey, 89% planned to continue Epidiolex treatment for their loved one. The most important stated reasons for continuing Epidiolex included seizure and non-seizure benefits such as reduced seizure frequency and severity/duration, as well as TAND-related improvements in cognition and language/communication. Results from the BECOME-LTC (BEhavior, COgnition, and More with Epidiolex in the Long-Term Care Setting) survey found that, among 102 nurses surveyed, 85% reported a reduction in overall frequency of any seizure type after Epidiolex initiation, with 49% reporting a greater than 50% reduction. Improvements were also observed across different seizure subtypes as well as in non-seizure outcomes, with nurses reporting improvements in emotional functioning, sleep, cognitive abilities, ability to communicate, and physical functioning. Results from CARE-EpiC (Caregiver Analysis of Real-world Epidiolex in Epilepsy Context), a cross-sectional caregiver survey, demonstrated reduced caregivers' need for additional support of their dependents' physical, emotional, and behavioral care after Epidiolex initiation and characterized improvements in their dependents' well-being as well as caregivers' experiences. A subgroup analysis evaluating treatment outcomes in patients with TSC (TSC group) versus other types of focal epilepsy (non-TSC group) treated with Epidiolex in the U.S. Expanded Access Program, found Epidiolex has similar effectiveness in TSC and other focal epilepsies, regardless of focal epilepsy type, further reinforcing the clinical profile of Epidiolex as a broad-spectrum agent. In the TSC group, Epidiolex was associated with a median reduction from baseline of 51%–87% in focal seizures and 44%–87% in total seizures. In the non-TSC group, Epidiolex was also associated with a median reduction from baseline of 46%–75% in focal and 46%–74% in total seizures. Epidiolex is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome or TSC in patients one year of age and older. All AES 2024 abstracts are available online at the following link: . A full list of Jazz Pharmaceuticals' presentations follows below: About Tuberous Sclerosis Complex Tuberous sclerosis complex (TSC) is a rare genetic condition.1 The condition causes mostly benign tumors to grow in vital organs of the body including the brain, skin, heart, eyes, kidneys and lungs2 and is a leading cause of genetic epilepsy.3 People with TSC may experience a variety of seizure types. One of the most common is infantile spasms that typically present in the first year of life; focal (or partial) seizures are also very common.4 TSC is associated with an increased risk of autism and intellectual disability5 and the severity of the condition can vary widely. In some children the disease is very mild, while others may experience life-threatening complications.4 Epilepsy is present in about 85 percent of patients with TSC and may progress to become intractable to medication.4,6,7 More than 60 percent of individuals with TSC do not achieve seizure control8 with standard treatments such as antiepileptic drugs, epilepsy surgery, ketogenic diet, or vagus nerve stimulation8 compared to 30-40 percent of individuals with epilepsy who do not have TSC who are drug resistant.9,10 About Dravet Syndrome Dravet syndrome (DS) is a rare genetic condition that appears during the first year of life with frequent fever-related seizures (febrile seizures). Later, other types of seizures typically arise, including myoclonic seizures (involuntary muscle spasms).11 Additionally, status epilepticus, a potentially life-threatening state of continuous seizure activity requiring emergency medical care, may occur. Children with DS typically experience poor development of language and motor skills, hyperactivity and difficulty relating to others. About Lennox-Gastaut Syndrome Lennox-Gastaut syndrome (LGS) begins in childhood. It is characterized by multiple types of seizures. People with LGS begin having frequent seizures in early childhood, usually between ages 3 and 5.12 More than three-quarters of affected individuals have tonic seizures, which cause the muscles to contract uncontrollably. Almost all children with LGS develop learning problems and intellectual disability. Many also have delayed development of motor skills such as sitting and crawling. Most people with LGS require help with usual activities of daily living. About Epidiolex®/Epidyolex® (cannabidiol) Epidiolex/Epidyolex is a prescription, plant-derived cannabis-based medicine administered as an oral solution which contains highly purified cannabidiol (CBD). Cannabidiol, the active ingredient in Epidiolex, is a cannabinoid that naturally occurs in the Cannabis sativa L. plant. The precise mechanisms by which Epidiolex exerts its anticonvulsant effect in humans are unknown. Epidiolex was approved by the U.S. Food and Drug Administration (FDA) for use in the U.S., the European Commission (EC) for use in Europe, the Medicines and Healthcare products Regulatory Agency (MHRA) for use in Great Britain, the Therapeutic Goods Administration for use in Australia, Swissmedic for use in Switzerland, the Food & Nutrition Services of the Israel Ministry of Health for use in Israel, and the New Zealand Medicines and Medical Devices Safety Authority for use in New Zealand, is an oral solution which contains highly purified cannabidiol (CBD). In the U.S., Epidiolex is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS) or tuberous sclerosis complex (TSC) in patients one year of age and older. Epidiolex has received approval in the European Union under the tradename Epidyolex for adjunctive use in conjunction with clobazam to treat seizures associated with LGS and DS in patients two years and older, and for adjunctive use to treat seizures associated with TSC, in patients two years of age and older. Epidiolex has received Orphan Drug Designation (ODD) from the U.S. FDA for the treatment of seizures associated with LGS, DS, and TSC. Similarly, Epidyolex received ODD from the European Medicines Agency (EMA) for the same indications. Important Safety Information & Indications CONTRAINDICATION: HYPERSENSITIVITY EPIDIOLEX (cannabidiol) oral solution is contraindicated in patients with a history of hypersensitivity to cannabidiol or any ingredients in the product. WARNINGS & PRECAUTIONS Hepatic Injury: EPIDIOLEX can cause dose-related transaminase elevations. Concomitant use of valproate and elevated transaminase levels at baseline increase this risk. Obtain transaminase and bilirubin levels prior to starting treatment, at 1, 3, and 6 months after initiation of treatment, and periodically thereafter, or as clinically indicated. Resolution of transaminase elevations occurred with discontinuation of EPIDIOLEX, reduction of EPIDIOLEX and/or concomitant valproate, or without dose reduction. For patients with elevated transaminase levels, consider dose reduction or discontinuation of EPIDIOLEX or concomitant medications known to affect the liver (e.g., valproate or clobazam). Dose adjustment and slower dose titration is recommended in patients with moderate or severe hepatic impairment. Consider not initiating EPIDIOLEX in patients with evidence of significant liver injury. There have been postmarketing reports of cholestatic or mixed patterns of liver injury. Elevated ammonia levels were reported in some patients with transaminase elevations; most taking concomitant valproate, clobazam, or both. Consider discontinuation or dose adjustment of valproate or clobazam if ammonia is elevated. Somnolence and Sedation: EPIDIOLEX can cause somnolence and sedation that generally occurs early in treatment and may diminish over time; these effects occur more commonly in patients using clobazam and may be potentiated by other CNS depressants. Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), including EPIDIOLEX, increase the risk of suicidal thoughts or behavior. Inform patients, caregivers, and families of the risk and advise them to monitor and report any signs of depression, suicidal thoughts or behavior, or unusual changes in mood or behavior. If these symptoms occur, consider if they are related to the AED or the underlying illness. Withdrawal of Antiepileptic Drugs: As with most AEDs, EPIDIOLEX should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus. ADVERSE REACTIONS: The most common adverse reactions in patients receiving EPIDIOLEX (≥10% and greater than placebo) include transaminase elevations; somnolence; decreased appetite; diarrhea; pyrexia; vomiting; fatigue, malaise, and asthenia; rash; insomnia, sleep disorder and poor-quality sleep; and infections. Hematologic abnormalities were also observed. PREGNANCY: EPIDIOLEX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Encourage women who are taking EPIDIOLEX during pregnancy to enroll in the EPIDIOLEX Pregnancy Surveillance Program and the North American Antiepileptic Drug (NAAED) Pregnancy Registry. DRUG INTERACTIONS: Strong inducers of CYP3A4 and CYP2C19 may affect EPIDIOLEX exposure. EPIDIOLEX may affect exposure to CYP2C19 substrates (e.g., clobazam, diazepam, stiripentol), orally administered P-gp substrates, or other substrates (see full Prescribing Information). Consider dose reduction of orally administered everolimus, with appropriate therapeutic drug monitoring, when everolimus is combined with EPIDIOLEX. A lower starting dose of everolimus is recommended when added to EPIDIOLEX therapy. Concomitant use of EPIDIOLEX and valproate increases the incidence of liver enzyme elevations. Pneumonia was observed more frequently with concomitant use of EPIDIOLEX and clobazam. Dosage adjustment of EPIDIOLEX or other concomitant medications may be necessary. INDICATIONS: EPIDIOLEX (cannabidiol) oral solution is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients 1 year of age and older. Please read the EPIDIOLEX full Prescribing Information for additional important information here . About Jazz Pharmaceuticals Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing potentially life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. Contacts: Media: Kristin Bhavnani Head of Global Corporate Communications Jazz Pharmaceuticals plc [email protected] Ireland +353 1 637 2141 U.S. +1 215 867 4948 Investors: Jeff Macdonald Executive Director, Investor Relations Jazz Pharmaceuticals plc [email protected] Ireland +353 1 634 3211 U.S. +1 650 496 2717 SOURCE Jazz Pharmaceuticals plc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultDrug ApprovalOrphan Drug

06 Dec 2024

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NEURELIS PRESENTS STUDIES ON SEIZURE CLUSTERS AT THE AMERICAN EPILEPSY SOCIETY ANNUAL MEETING

Ten poster presentations highlight analyses of immediate-use seizure medication and treatment for seizure clusters SAN DIEGO, Dec. 6, 2024 /PRNewswire/ -- Neurelis, Inc., today announced details of its presentations at the American Epilepsy Society (AES) Annual Meeting to be held December 6-10 in Los Angeles. The collection of ten posters highlights analyses of immediate-use seizure medication for treatment of seizure clusters. A wide variety of presentations include pharmacokinetics (PK) and safety analyses from the study of VALTOCO® (diazepam nasal spray) for the treatment of seizure clusters in patients with epilepsy aged 2-5 years, time to treatment and seizure cluster termination, treatment of prolonged seizures within a cluster, as well as potential drug effects beyond the immediate treated seizure cluster, implications of seizure clusters in the epilepsy monitoring unit, and development of evidence-based self-management criteria encompassing the use of immediate-use seizure medication. "The AES Annual Meeting is an important opportunity for the epilepsy community to engage with each other on critical research and the latest advancements in the field," said Adrian L. Rabinowicz, MD, Neurelis Chief Medical Officer. "We are proud to have such a strong set of pre-clinical and clinical presentations to share at this year's meeting and look forward to connecting with healthcare practitioners, researchers, people with epilepsy, and care partners as we share a common mission to improve quality of life for people with epilepsy." Neurelis' presentations at the Annual Meeting include the following. Poster Session 1, December 7th 12:00 PM to 2:00 PM PT: Exploring Proposed Recommendations for Acute Cluster Treatment and Rapid and Early Seizure Termination Using Data from a Long-Term Safety Study of Diazepam Nasal Spray Presentation of data from the long-term safety study of diazepam nasal spray explores clinical evidence supporting recent expert consensus recommendations for medications appropriate for acute cluster treatment and for rapid and early seizure termination. The study objective was to examine a single immediate-use seizure medication for both acute cluster treatment and rapid and early seizure termination, with the potential to simplify patient care. Findings in the study demonstrate the benefit of diazepam nasal spray use for both termination of acute seizure clusters and prolonged seizures within clusters. Effect of Diazepam Intervention on Seizure-Cluster Expression in a Rat Model of Epilepsy This poster shares data from a preclinical study investigating the possible impact of diazepam on seizure cluster expression in a post-kainic acid status epilepticus (KASE) rat model of chronic epilepsy. Results demonstrated that in this rat model, expression was consistent with potential disease-modifying effects on seizure clusters, including reduced seizure severity, interseizure interval, and stability within clusters, supporting further exploration of the potential disease-modifying effect of diazepam. Is Disease Modification in Seizure Clusters Possible? Results From the Long-Term Safety Study of Diazepam Nasal Spray A subgroup analysis of patients treated with diazepam nasal spray in a long-term open label safety study was evaluated to assess the intervals of treated seizure clusters (SEIVAL) over time as a potential indicator of disease modification. Results were consistent across subgroups based on age, sex, with and without change in concomitant medications, pediatric developmental/epileptic encephalopathies, with prolonged seizures, and with self-administration of diazepam nasal spray. Poster Session 2, December 8th 12:00 PM to 2:00 PM PT: Treatment of Prolonged Seizure with Diazepam Nasal Spray: A Post Hoc Cohort Analysis Prolonged seizures within a seizure cluster, treated with diazepam nasal spray within 5-15 minutes of seizure onset, were investigated in a post hoc subgroup analysis of a Phase 3 long-term safety study. Across age, seizure type, and high treatment usage subgroups, similar times to seizure termination were observed. Results also show low use of second doses demonstrating preserved effectiveness in seizures that have become prolonged within a cluster. Pharmacokinetic Characteristics of Diazepam Nasal Spray in Children with Epilepsy 2 to 5 Years of Age The PK of diazepam nasal spray for treatment of seizure clusters in patients 2-5 years of age was evaluated. Results demonstrated that diazepam nasal spray was readily absorbed with similar exposure for patients aged 2-3 years and 4-5 years and also showed a consistent PK profile in 2-5 year olds with that of older children and adults aged 6-59 years. Safety Profile of Diazepam Nasal Spray in Patients Aged 2-5 Years from an Ongoing, Open-Label 180-Day Safety Period Following Pharmacokinetic Sampling in a Phase 1/2a Study Safety of diazepam nasal spray in patients aged 2-5 years was assessed through the 180-day open-label safety period. Overall, the safety profile of diazepam nasal spray was similar to that established for older children and adults. Second Dose Use as a Proxy for Effectiveness of Diazepam Nasal Spray in Patients with Epilepsy Aged 2-5 Years: Interim Results from a Phase 1/2a Study The effectiveness of diazepam nasal spray in the 2-5 years age group was evaluated using the proportion of second doses (doses given within 24 hours of initial doses) used to treat seizure clusters as a proxy for effectiveness. Results showed comparable rates of seizure clusters treated with second doses among pediatric patients aged 6-17 years in the long-term safety study of diazepam nasal spray, supporting the effectiveness of the age-based dosing regimen in patients aged 2-5. Potential Adverse Events of Clinical Interest with Use of Diazepam Nasal Spray in Children: Interim Results from an Ongoing Open-Label, Pharmacokinetic and Safety Study Treatment-emergent adverse events (TEAEs) of clinical interest associated with the use of benzodiazepines were assessed in patients aged 2-5 who received at least one dose of diazepam nasal spray through the 180-day open-label safety period of a Phase 1/2a pharmacokinetic and safety study. Treatment-related TEAEs of clinical interest were uncommon and primarily nasal, with none reported in more than one patient. There were no clinically significant changes in vital signs or laboratory values and no new safety signals of clinical interest in children aged 2-5 years. Immediate-Use Seizure Medication for Acute Repetitive Seizures in the Epilepsy Monitoring Unit: Experiences from an Expert Panel A pilot survey of a group of expert epileptologists discussed practice experience with immediate-use seizure medications (ISM, rescue) before, during, and after long-term video-electroencephalogram monitoring (LTVEM) in the epilepsy monitoring unit (EMU). Results highlighted the importance of expanding this research and the potential value of expert guidelines. Development of Self-Management Tool for Individuals with Seizure Clusters The study presents an ongoing study focused on self-management for people with epilepsy and a history of negative health events (SMART), an evidence-based program investigating integration of immediate-use seizure medications (rescue medication) into the self-management program. The American Epilepsy Society is dedicated to advancing knowledge and supporting evidence-based clinical practice to improve outcomes for persons with epilepsy and their families. About Neurelis Neurelis, Inc., is a neuroscience company focused on the development and commercialization of therapeutics for the treatment of epilepsy and neurologic disorders characterized by high unmet medical need. The FDA has approved Neurelis' VALTOCO® (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from an individual's usual seizure pattern in adult and pediatric patients 6 years of age and older. VALTOCO is a proprietary formulation of diazepam incorporating the science of INTRAVAIL®, a transmucosal absorption enhancement technology that enables the noninvasive delivery of a broad range of protein, peptide and small-molecule drugs. For more information on VALTOCO, please visit . For the latest scientific information on VALTOCO, please visit . Neurelis is also developing NRL-1004, an investigational, Phase 1 stage intranasal olanzapine for treatment of acute agitation episodes associated with schizophrenia and bipolar disorder. In addition, Neurelis is also developing NRL-1049 (previously known as BA-1049), an investigational, Phase 1 new chemical entity Rho kinase (ROCK) inhibitor, for the treatment of cerebral cavernous malformations (CCMS), a rare disorder of the central nervous system (CNS). For more information on Neurelis, please visit . Important Safety Information about VALTOCO: Indication VALTOCO® (diazepam nasal spray) is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 6 years of age and older. WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation. The use of benzodiazepines, including VALTOCO, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing VALTOCO and throughout treatment, assess each patient's risk for abuse, misuse, and addiction. The continued use of benzodiazepines may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Although VALTOCO is indicated only for intermittent use, if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of VALTOCO may precipitate acute withdrawal reactions, which can be life-threatening. For patients using VALTOCO more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue VALTOCO. Contraindications: VALTOCO is contraindicated in patients with: Hypersensitivity to diazepam Acute narrow-angle glaucoma Central Nervous System (CNS) Depression Benzodiazepines, including VALTOCO, may produce CNS depression. Caution patients against engaging in hazardous activities requiring mental alertness, such as operating machinery, driving a motor vehicle, or riding a bicycle, until the effects of the drug, such as drowsiness, have subsided, and as their medical condition permits. The potential for a synergistic CNS-depressant effect when VALTOCO is used with alcohol or other CNS depressants must be considered, and appropriate recommendations made to the patient and/or care partner. Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including VALTOCO, increase the risk of suicidal ideation and behavior. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or unusual changes in mood or behavior. Glaucoma Benzodiazepines, including VALTOCO, can increase intraocular pressure in patients with glaucoma. VALTOCO may only be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. VALTOCO is contraindicated in patients with narrow-angle glaucoma. Neonatal Sedation and Withdrawal Syndrome Use of VALTOCO late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in the neonate. Monitor neonates exposed to VALTOCO during pregnancy or labor for signs of sedation and monitor neonates exposed to VALTOCO during pregnancy for signs of withdrawal; manage these neonates accordingly. Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative VALTOCO is not approved for use in neonates or infants. Serious and fatal adverse reactions, including "gasping syndrome," can occur in neonates and low-birth-weight infants treated with benzyl alcohol–preserved drugs, including VALTOCO. The "gasping syndrome" is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known. Adverse Reactions The most common adverse reactions (at least 4%) were somnolence, headache, and nasal discomfort. Diazepam, the active ingredient in VALTOCO, is a Schedule IV controlled substance. To report SUSPECTED ADVERSE REACTIONS, contact Neurelis, Inc. at 1-866-696-3873 or FDA at 1-800-FDA-1088 (). Please read full Prescribing Information , including Boxed Warning. Contacts: Brittany Bradrick, Chief Operating Officer and Chief Financial Officer, +1 858 251 2100 SOURCE Neurelis, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultDrug ApprovalPhase 1Phase 3

100 Deals associated with Diazepam

External Link

KEGG	Wiki	ATC	Drug Bank
D00293	Diazepam	N05BA01	DB00829

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Organophosphate Poisoning	JP	Maruishi Pharmaceutical Co., Ltd.	02 Dec 2003
Febrile Seizures Associated With Afebrile Seizures	JP	Takata Seiyaku Co., Ltd.	03 Jul 1992
Seizures	JP	Takata Seiyaku Co., Ltd.	03 Jul 1992
Heart Diseases	CN	Chengdu First Pharmaceutical Co. Ltd.	01 Jan 1981
Anesthesia	JP	Maruishi Pharmaceutical Co., Ltd.	30 Aug 1969
Habit Spasms	JP	Maruishi Pharmaceutical Co., Ltd.	30 Aug 1969
Depressive Disorder	JP	Takeda Pharmaceutical Co., Ltd.	01 Nov 1964
Neurotic Disorders	JP	Takeda Pharmaceutical Co., Ltd.	01 Nov 1964
Alcohol Abstinence	US	Waylis Therapeutics LLC	15 Nov 1963
Anxiety Disorders	US	Waylis Therapeutics LLC	15 Nov 1963
Epilepsy	US	Waylis Therapeutics LLC	15 Nov 1963
Muscle Spasticity	US	Waylis Therapeutics LLC	15 Nov 1963

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute repetitive seizure	Phase 3	US	Neurelis, Inc.	11 Apr 2016

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01938092 (CTgov)	Phase 2	Pelvic Pain \| Pelvic Floor Disorders	50	Diazepam (Diazepam)	azkwewpwml(xwcmzkprdf) = estftbnbbj zhnfugthmw (rlfzjulehz, tbskfsjfde - ecdafoespa) View more	-	03 Sep 2024
NCT01938092 (CTgov)	Phase 2	Pelvic Pain \| Pelvic Floor Disorders	50	Placebo (Placebo)	azkwewpwml(xwcmzkprdf) = lgglgwolkq zhnfugthmw (rlfzjulehz, afrruqjkri - ezjgmrcubj) View more	-	03 Sep 2024
FDA_CDER Manual	Not Applicable	Epilepsy	91	Diazepam Rectal Gel (First Study)	kqcuakiapj(nmfgpauhwy) = ekewtkugur ematwxvecz (jqydrsclml ) View more	Positive	26 Apr 2024
FDA_CDER Manual	Not Applicable	Epilepsy	114	Diazepam Rectal Gel (Second Study)	nseaeyqcab(fdhnqmdpjs) = soygyroqyl ohgoghylim (syhgrerrio ) View more	Positive	26 Apr 2024
AAN2024	Phase 3	Seizures	163	Diazepam Nasal Spray (Adults (18-65 years))	tmzpzfxetn(roafbjrafe) = nkfkmedrcd rmnhioryfh (aizfozgfbv )	Positive	09 Apr 2024
AAN2024	Phase 3	Seizures	163	Diazepam Nasal Spray (Pediatric patients (6-17 years))	tmzpzfxetn(roafbjrafe) = wipjelgemo rmnhioryfh (aizfozgfbv )	Positive	09 Apr 2024
NCT03818919 (CTgov)	Phase 2	Analgesia \| Rotator Cuff Tear Arthropathy	70	Acetaminophen+Diazepam+Ketorolac+Celecoxib+Gabapentin (Post-Operative Non Opioid Pain Protocol)	aguryluzdq(vawixzvoni) = ixjzmdgzhs kieddxduie (wafdxyxkbs, datvzdpenn - ncvyhrfnfc) View more	-	02 Apr 2024
NCT03818919 (CTgov)	Phase 2	Analgesia \| Rotator Cuff Tear Arthropathy	70	Hydrocodone-Acetaminophen (Post-Operative Traditional Pain Protocol)	aguryluzdq(vawixzvoni) = sydpceoazd kieddxduie (wafdxyxkbs, blfvnyoihv - atmgwqxazx) View more	-	02 Apr 2024
NCT02721069 (Pubmed \| Neurol Ther) Manual	Phase 3	Acute repetitive seizure	3,225	NRL-1pam Nasal Spray	gwrzhanlus(ckpdvbqull) = yjilftjpix syrxxpnenr (dviqavhywv ) View more	Positive	01 Feb 2024
NEWS Manual	Phase 3	Seizures	-	diazepam nasal spray	stgffhegsr(wgldrcftqv) = proportion of patients who achieved resolution of clinically relevant seizures within 10 minutes after administration of a single dose and who remained free from seizures or convulsions for 30 minutes after a single dose upsyjukjbm (pbqltvyyyx ) Met	Positive	18 Oct 2023
NCT02721069 (DIAZ.001.05, CNS2023)	Phase 3	CBD	78	No CBD	crwdjxbhnd(luexnisahz) = xzqrrnqqay fnjcdbdwvm (cciahyxbfw ) View more	-	01 Oct 2023
NCT02721069 (DIAZ.001.05, CNS2023)	Phase 3	CBD	78	Oral-solution CBD	crwdjxbhnd(luexnisahz) = zejfjrwzdr fnjcdbdwvm (cciahyxbfw ) View more	-	01 Oct 2023
CNS2023	Phase 3	Acute repetitive seizure	78	Diazepam nasal spray	sgadklwmpb(fufnrhqzag) = tsnskfjmxp pnxvwqobpl (pdtoijnurj )	-	01 Oct 2023
IEC2023	Not Applicable	Acute repetitive seizure	175	Diazepam nasal spray	wjnnjbhbiy(ndurpgjeze) = jqtlaoitpr lliwrrtevl (fmizirlknd )	Positive	04 Sep 2023

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