Last update 04 Nov 2024

Lorazepam

Last update 04 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryLorazepam, a minute molecular compound, acts as an agonist that targets the GABAA receptor. It boasts a varied scope of medical uses, such as assuaging anxiety disorders, depressive disorder, epilepsy, sleep initiation and maintenance disorders, and even catatonia in Down Syndrome patients. Initially greenlighted by Bausch Health in 1970, this drug ushers in a binding process, whereby the GABAA receptor in the central nervous system is targeted, and subsequently leads to heightened GABAergic inhibitory neurotransmission, which deftly quashes neuronal activity and thus facilitates sedative, anxiolytic, and anticonvulsant effects. Despite the benefits of this medication, it is prudent to bear in mind the potential for adverse effects, which may include drowsiness, dizziness, and impaired coordination. With prolonged usage, there is a possibility of developing dependence on the drug, hence why it is indispensable to utilize Lorazepam only under the watchful eye of a competent healthcare provider.

Drug Type

Small molecule drug

Synonyms

Lora-Pita Intravenous, Lorazepam (JP17/USP/INN), o-Chlorooxazepam

+ [16]

Target

GABAA receptor

Mechanism

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

Therapeutic Areas

Nervous System DiseasesOther DiseasesCongenital Disorders

Active Indication

Sleep Initiation and Maintenance DisordersSedationStatus Epilepticus+ [4]

Inactive Indication-

Originator Organization

Bausch Health Cos., Inc.

Active Organization

Bausch Health US LLC

Jiangsu Nhwa Pharmaceutical Co., Ltd.Hikma Pharmaceuticals USA, Inc.

+ [4]

Inactive Organization

Pfizer Inc.

Drug Highest PhaseApproved

First Approval Date

US (30 Sep 1977),

Anxiety DisordersDepressive Disorder

Regulation-

Structure

Molecular FormulaC15H10Cl2N2O2

InChIKeyDIWRORZWFLOCLC-UHFFFAOYSA-N

CAS Registry846-49-1

124

Clinical Trials associated with Lorazepam

NCT06496854 / Not yet recruitingPhase 2IIT

Prescribing Lorazepam for IUD Insertion: Pilot Feasibility Study

The objective of this pilot study is to discuss the feasibility of prescribing lorazepam prior to IUD insertion and of measuring effect of lorazepam on anxiety and pain with Intrauterine Device (IUD) insertion. The target population for this study will be 25 adult participants scheduled for an IUD insertion at a UW Family Medicine residency clinic. Participants will be followed for 1 appointment visit.

Start Date01 Sep 2024

Sponsor / Collaborator

University of Wisconsin

CTRI/2024/08/072429 / Not yet recruitingPhase 3

An open-label phase III randomized controlled trial comparing metoclopramide, thalidomide, prochlorperazine, and lorazepam for treating breakthrough chemotherapy-induced nausea and vomiting in patients receiving olanzapine as part of antiemetic prophylaxis for highly emetogenic chemotherapy. - Nil

Start Date01 Sep 2024

Sponsor / Collaborator-

CTRI/2024/07/070438 / Not yet recruitingPhase 4IIT

Comparative study of Intramuscular Midazolam, Lorazepam and Haloperidol-Promethazine combination for management of acute agitation. - NIL

Start Date22 Jul 2024

Sponsor / Collaborator

Government Medical College

100 Clinical Results associated with Lorazepam

100 Translational Medicine associated with Lorazepam

100 Patents (Medical) associated with Lorazepam

4,450

Literatures (Medical) associated with Lorazepam

01 Jan 2025·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Repeated lyophilization: A neo-method for urine-based reference materials preparation

Article

Author: Liu, Yu ; Zhi, Yujie ; Hu, Jing ; Jin, Wenhui ; Zhang, Zhen ; Liu, Wei ; Zheng, Qiongying ; Zhang, Wenping ; Lu, Jiayue ; Dou, Quanlu ; Chen, Hang

In urine drug testing, a cut-off value is often imposed to determine whether the sample is negative or positive. A matrix containing a reference substance helps counteract the adverse effects of the urine matrix across different laboratories to improve the consistency of final results. However, as a biological matrix, urine is prone to corruption and other problems that make it difficult to use as a reference sample. In this study, morphine, nitrazepam, lorazepam, buprenorphine, zolpidem, midazolam, diazepam, and clozapine commonly used in clinical practice were selected as target analytes, and the preparation process was further optimized to repeated lyophilization, in order to obtain more effective, stable, and accurate urine matrix reference materials (mRMs). The appropriate urine density (1.010-1.017 kg/m³) for preparing lyophilized samples was investigated through density determination. Conducting repeated lyophilizations resulted in a denser powder with reduced susceptibility to collapse and improved the quality of lyophilized urine samples. Lyophilized urine mRMs could be stored at room temperature for one month or under refrigeration conditions (4 ℃) for six months.

31 Dec 2024·Journal of Pharmaceutical Policy and Practice

Use and misuse of psychoactive medicines: a descriptive cross-sectional study in a densely populated region of Portugal

Article

Author: Carmona Araújo, Ana ; Goulão, João ; Guerreiro, José Pedro ; Martins, Ana Paula ; Bulhosa, Carolina ; Alves da Costa, Filipa

Introduction:

Although psychoactive medicines (PMed) are needed in several psychiatric conditions, their use and misuse bear risks. We aimed at estimating the prevalence of PMed use and misuse.

Methods:

Data on all PMed prescribed in 2017 and dispensed in community pharmacies of the Lisbon and Tagus Valley region of Portugal (ARSLVT) were extracted from ARSLVT medicines' dispensing database. For 21 PMed among prescription opioids, benzodiazepines and z-drugs (BZDR), antidepressants (AD) and anticonvulsants (AC), we estimated the number of users of each PMed, and assessed PMed misuse by a set of proxy indicators for studying this practice: chronic use (use of ≥180 DDD during the study period) of PMed intended for short-term treatments, concomitant use of several PMed, in particular if involving long-term (≥ 30 days) opioid analgesic (OA) use, and doctor shopping (patients consulting several physicians in order to have access to a quantity higher than intended by each prescriber). Data were analysed using descriptive statistics and hypothesis testing, and multivariate logistic regression was used to explore potential factors affecting long-term concomitant treatment of chronic OA with other PMed.

Results:

PMed use prevalence was 21.7%: 6.6% for OA, 12.7% for benzodiazepines (BZD), 5.3% for AD and 2.8% for AC. BZDR were mainly prescribed in primary care and OA in hospital outpatients. Chronic use of PMed was observed in 25%, especially with sertraline and buprenorphine for opioid use disorder (long-term treatment), and lorazepam (short-term treatment). About 56.6% of OA chronic users were long-term concurrent users with other PMed, mainly BZDR. Risk of abuse was low for BZDR, whilst four opioids had meaningful doctor shopping indicators - fentanyl, opioid use disorder buprenorphine, morphine and hydromorphone.

Conclusions:

BZD are the main PMed used in ARSLVT, often chronically, especially lorazepam. Prevalence of OA use is low, although with higher risk of misuse than BZDR. Concomitant use of several PMed is frequent.

02 Dec 2024·Journal of biomolecular structure & dynamics

Gene expression analysis reveals GRIN1, SYT1, and SYN2 as significant therapeutic targets and drug repurposing reveals lorazepam and lorediplon as potent inhibitors to manage Alzheimer’s disease

Article

Author: T., Premkumar ; Lulu S., Sajitha ; Katta, Bhavana ; Sundararajan, Vino

Alzheimer's disease (AD) is a slowly progressive neurodegenerative disease and a leading cause of dementia. We aim to identify key genes for the development of therapeutic targets and biomarkers for potential treatments for AD. Meta-analysis was performed on six microarray datasets and identified the differentially expressed genes between healthy and Alzheimer's disease samples. Thereafter, we filtered out the common genes which were present in at least four microarray datasets for downstream analysis. We have constructed a gene-gene network for the common genes and identified six hub genes. Furthermore, we investigated the regulatory mechanisms of these hub genes by analysing their interaction with miRNAs and transcription factors. The gene ontology analysis results highlighted the enriched terms significantly associated with hub genes. Through an extensive literature survey, we found that three of the hub genes including GRIN1, SYN2, and SYT1 were critically involved in disease development. To leverage existing drugs for potential repurposing, we predicted drug-gene interaction using the drug-gene interaction database, and performed molecular docking studies. The docking results revealed that the drug compounds had strong interactions and favorable binding with selected hub genes. Lorazepam exhibits a binding energy of -7.3 kcal/mol with GRIN1, Lorediplon exhibits binding energies of -7.7 kcal/mol and -6.3 kcal/mol with the SYT1, and SYN2 respectively. In addition, 100 ns molecular dynamics simulations were carried out for the top complexes and apo protein as well. Furthermore, the MM-PBSA free energy calculations also revealed that these complexes are stable and had favorable energies. According to our study, the identified hub gene could serve as a biomarker as well as a therapeutic target for AD, and the proposed repurposed drug molecules appear to have promising efficacy in treating the disease.Communicated by Ramaswamy H. Sarma.

News (Medical) associated with Lorazepam

12 Sep 2024

·www.biospace.com

The API Innovation Center Receives $14 Million in Strategic Funding to Bolster U.S. Pharmaceutical Independence

Biden-Harris Administration funds first Defense Production Act Title III award to onshore manufacturing of ingredients for essential medicines ST. LOUIS--(BUSINESS WIRE)--The API Innovation Center (APIIC) today announced that it has been awarded funding by the Administration for Strategic Preparedness and Response’s (ASPR) Center for Industrial Base Management and Supply Chain (IBMSC) to lead the development and domestic production of three critical active pharmaceutical ingredients (APIs) used in the treatment of asthma, diabetes, and anxiety disorders. APIIC will leverage advanced manufacturing technologies and cutting-edge research to further national strength in pharmaceutical innovation and supply chain resilience. The BioMaP-Consortium is a multi-purpose acquisition vehicle comprised of industry partners across the drug and vaccine manufacturing supply chain supported by ASPR’s Biomedical Advanced Research and Development Authority (BARDA). IBMSC will provide $14 million in funding and APIIC will invest an additional $2.4 million into the development of these critical APIs. This funding marks a significant step forward in securing the U.S. pharmaceutical supply chain and addressing national health security risks. At least 83% of the nation’s top 100 generic medicines have no U.S.-based source for the small-molecule APIs found in today’s medication. This dependency on foreign manufacturers has left the U.S. pharmaceutical supply chain vulnerable to shortages and geopolitical conflicts while domestic facilities operate below capacity. The decrease in U.S.-based production for APIs and key starting materials (KSMs) used to make them is widely recognized as a major driver behind this significant national health security risk. While much work remains to improve the return on investment for developing medicines domestically, funding through the BioMaP-Consortium represents a key investment in the ongoing efforts to reshore critical medicines and address ever-increasing drug shortages. Initiative to Address Availability of Essential Medications This initiative will see APIIC lead the development and production of three critical APIs, each chosen for their vital role in U.S. health care, shortage history, as well as inclusion on essential medicines lists: Albuterol: Used to treat asthma and other respiratory conditions. Desmopressin Acetate: Used to treat diabetes insipidus & blood coagulation conditions. Lorazepam: Used to treat anxiety. “This funding represents both a financial commitment and a significant step towards securing America’s pharmaceutical resiliency and patient access to critical medicines. By focusing on developing these high-impact molecules, we are creating a private-public blueprint for driving self-reliance that is essential for national health security and can be replicated across the country,” said Tony Sardella, chair and founder of APIIC. Partnership and Impact This project harnesses the strengths of APIIC’s extensive partner network, including collaborations with leading universities, pharmaceutical manufacturers, and suppliers of KSMs. APIIC will unite the resources and advanced manufacturing technologies of Mallinckrodt Specialty Generics, Apertus Pharmaceuticals, MilliporeSigma, and the University of Missouri–St. Louis (UMSL) to enhance the quality, efficiency, and global competitiveness of U.S.-based pharmaceutical manufacturing. These strategic collaborations form a dynamic product team, capitalizing on each member’s specific expertise, with APIIC providing funding and support to harness their strengths and advanced manufacturing capabilities. “Mallinckrodt Specialty Generics is proud to partner with the API Innovation Center on this critical initiative to bolster the U.S. pharmaceutical supply chain. Our proven expertise in the development, manufacture, and commercialization of active pharmaceutical ingredients in the U.S. positions us extremely well to contribute to this effort. By collaborating with APIIC and its partners, we are both addressing the nation’s drug shortage challenges and strengthening the nation’s ability to manufacture essential medicines domestically,” said Stephen Welch, executive vice president & head of Mallinckrodt Specialty Generics. APIIC will collaborate closely with Apertus Pharmaceuticals on research and development work, leveraging advanced manufacturing technology to produce these critical molecules. “Collaborating with the API Innovation Center has enabled us to scale our cutting-edge research and play a key role in this national initiative to strengthen our pharmaceutical supply chain,” said David Gindelberger, chief executive officer of Apertus Pharmaceuticals. MilliporeSigma, a small and large molecule contract development and manufacturing organization (CDMO) with facilities in St. Louis, will also play a pivotal role. “We are excited to bring our 25 years of CDMO expertise in organic synthesis and bioconjugation of ADCs, producing Active Pharmaceutical Ingredients (API), excipients and critical raw materials, to this partnership. This initiative will not only mitigate risks associated with supply disruptions but can also enhance the U.S. bioeconomy,” said Mark Cooley, site director of one of the St. Louis MilliporeSigma facilities involved in the consortium. “Partnering with the API Innovation Center on this important initiative allows us to leverage our strengths in research, workforce development, and community engagement to support a more secure and self-reliant pharmaceutical supply chain. UMSL is proud to play a key role in advancing these critical efforts, which will have lasting impacts on both our region’s economy and the nation’s health security,” said Dr. Chris Spilling, vice chancellor for research and economic and community development at the University of Missouri-St. Louis. A Roadmap for a Resilient Supply Chain in Missouri APIIC, together with the State of Missouri and the Missouri Technology Corporation, has been developing a state-supported model in the St. Louis region and a strategic framework for creating a resilient national pharmaceutical manufacturing ecosystem. This model is designed to be a replicable blueprint that compliments Missouri’s strengths in infrastructure and workforce development to restore U.S. leadership in pharmaceutical production. To date, the State of Missouri has committed approximately $18 million to API reshoring efforts, demonstrating to other states how to support the “Missouri Model” and take the lead in addressing national supply chain challenges. “Missouri is leading in restoring America’s pharmaceutical manufacturing strength. By focusing on developing active pharmaceutical ingredients right here in Missouri, we are tackling a pressing national health security issue—our over-reliance on foreign suppliers,” said Gov. Mike Parson. “Recognizing our strengths, particularly in pharmaceutical manufacturing, we collaborated with the General Assembly to invest in bringing critical medicine production back to the U.S. The state’s investment, now bolstered by federal support, is a clear indicator that what we are doing in Missouri is working. We are not just talking about solutions. We’re delivering results that are necessary steps toward safeguarding the health and security of our nation.” As it looks to the future, APIIC is committed to driving the U.S. towards pharmaceutical self-reliance, ensuring every hospital, pharmacy, and patient has access to domestically produced critical medication to support national health security. This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Office of Industrial Base Management and Supply Chain (IBMSC), under OT number #75A50123D00003. About the API Innovation Center: The API Innovation Center (APIIC) is a 501(c)(3) nonprofit public benefit organization headquartered in St. Louis, Missouri, dedicated to driving health security and economic growth for the nation and its citizens through U.S.-based production of critical medicines. By investing in and collaborating along the supply chain, APIIC’s model contracts with leading U.S.-based specialists within their pharmaceutical ecosystem to develop and manufacture high-quality domestically produced Active Pharmaceutical Ingredients. APIIC is also committed to expanding access to critical medications through strategic partnerships to commercialize market-competitive supplies of finished drug products and build resiliency in the supply chain. Their mission is to ensure every hospital, pharmacy, and patient has access to domestically produced critical medication to fortify national health security. APIIC is supported by the state of Missouri through the Advanced Manufacturing Resiliency Grant awarded by the Missouri Technology Corporation. To learn more, visit: apicenter.org . About Apertus Pharmaceuticals: Apertus Pharmaceuticals is a contract development and manufacturing organization (CDMO) that develops and manufactures device, OTC and prescription pharmaceutical products. Services include product de-formulation, formulation development, process development, and manufacturing (clinical batch to intermediate scale), including product serialization. Apertus performs an extensive range of analytical method development and validation as well as provides stability programs for all of the medications it produces. Apertus currently manufactures solid oral dose, suppository, liquid and cream products. Apertus is cGMP compliant and maintains Drug Enforcement Administration research and analytical registrations for Schedules II-V. To learn more about Apertus Pharmaceuticals, visit: apertuspharma.com . About Mallinckrodt Specialty Generics: Mallinckrodt’s Specialty Generics business segment is a 150+ year-old business that manufactures approximately 50 FDA-approved active pharmaceutical ingredients and approximately 100 FDA-approved finished dose pharmaceutical products across our network of U.S.-based manufacturing sites. To learn more about Mallinckrodt Specialty Generics, visit . About the Life Science business of Merck KGaA, Darmstadt, Germany The Life Science business of Merck KGaA, Darmstadt, Germany, which operates as MilliporeSigma in the U.S. and Canada, has more than 27,000 employees and more than 55 total manufacturing and testing sites worldwide, with a portfolio of more than 300,000 products focused on scientific discovery, biomanufacturing and testing services. Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and electronics. Follow MilliporeSigma on Twitter @MilliporeSigma, on Facebook @MilliporeSigma and on LinkedIn . About the University of Missouri–St. Louis: A Tier 1 national university and Carnegie R2 classification—Doctoral University with High Research Activity— public research university, UMSL, and its four-campus University of Missouri System, provides strong research programs in chemical organic synthesis and advanced pharmaceutical manufacturing methods, such as continuous flow technologies, along with strong industry partnerships. To learn more about the University of Missouri–St. Louis, visit: umsl.edu . Contacts Kaylee Schreiner kaylee.schreiner@fleishman.com

Acquisition

16 Jul 2024

·www.prnewswire.com

Benzodiazepine Drugs Market to Reach US$ 3.2 Billion by 2034, Growing at 3.5% CAGR | Impact of Psychological Conditions and Aging Population - Reports TMR

Benzodiazepine drugs are vastly used as psychoactive drugs, which can be used to control seizures, alcohol withdrawal symptoms, and other issues related to the psychological conditions of a human being. With the activity of drugs closely related to brain stimulation, the drug can act as a relaxant for muscles in the body. WILMINGTON, Del., July 16, 2024 /PRNewswire/ -- Owing to different governing factors, the development of the benzodiazepine drug market is expected to traverse a sluggish path of advancement during the forecasted period. With a CAGR of 3.5%, the industry will proceed to reach USD 3.2 billion by 2034. The last recorded size of the ecosystem was USD 2.2 billion in 2023. With the changing lifestyles and mounting pressures to cope with an accelerated pace of living, many people have been facing psychological issues. The growing prevalence of trauma, anxiety, mental fatigue, and many other psychological conditions is observed to have increased recently. To treat such medical conditions, an appropriate relaxant must be applied to get the desired results. This growing prevalence is a clear sign of an important driver that promises to elevate the size of the competitive space during the forecasted period. The rising geriatric population is contributing to the growing cases of insomnia. Along with the abovementioned factors, the growing senior population is trying to find solutions for issues like sleep deprivation. To cater to such issues, the use of benzodiazepine drugs is observed to have increased. Propel Your Business Success: Secure Your Sample of Our Latest Report Now! Due to the sedative properties of drugs, the use of such chemicals is observed to have gained traction in the case of muscle relaxants. To cater to such muscle spasms and other related issues, such drugs can be effective. This factor drives the sales of such drugs. With the spurring of innovation and growth in the technological infrastructure, product augmentation has become possible. Key players in the ecosystem invest more in innovation to alter formulations of drugs. This elevates drug delivery and response time, delivering better results. Rising investments in the pharmaceutical and healthcare industries have generated better prospects for leading organizations. As more market openings have been created in the industry, the scope of expanding the market increases for key players, benefitting the size of the industry. The growing research and development activities are expected to augment the drug efficacy and efficiency, which will likely benefit the industry. Due to this, such efforts have been fueling the industry's progress, creating opportunities for new entrants. Benzodiazepine Drugs Market Report Scope: Key Findings from the Market Report The competitive landscape of benzodiazepine drugs can be segmented into different categories depending on various parameters. Based on the drug type, Alprazolam is used to control anxiety issues. The drug controls an abnormal excitement in the brain. Based on the application segment, anxiety is the largest shareholder in the industry. Due to the changing lifestyle, such cases are increasing at an alarming rate, gaining more demand for the segment. Based on the time of use, various prolonged cases of such drugs are seen to have gained momentum. Curing deep psychological impacts is surging the demand for the segment. Based on the end-user, hospital pharmacies govern the largest market share due to better availability of drugs. Regional Profile The growing awareness of psychological health in Asia-Pacific is creating better prospects for the global benzodiazepine drug market. With the growing drug research activities in Europe, the demand for such drugs will likely increase due to a larger canvas. The progress of the healthcare and pharmaceutical industry in North America is a key factor in helping the region lead the global landscape. Competitive Landscape Among different firms expanding in the industry, Pfizer Inc. is a key player that produces different products to expand. Such products include aminophylline, etomidate, argatroban injection, and many more. UCB S.A. is another important player producing solutions for Briviact (brivaracetam) Epilepsy, Ankylosing spondylitis, and Myasthenia Gravis. Hikma Pharmaceuticals PLC operates in different verticals, including injectables, oral drugs, and other segments. Key Developments in the Benzodiazepine Drug Market In December 2023, Pfizer Inc. acquired Seagen. This move bolstered the position of the organization in the industry. In March 2024, UCB S.A. invested in IMIDomics, Inc. to innovate solutions for immune-mediated inflammatory diseases. This product launch helped the business augment products, bolstering the position in the market. Key Players Pfizer Inc. UCB S.A. Hikma Pharmaceuticals PLC Teva Pharmaceutical Industries Ltd. H.Lundbeck A/S Apotex Inc. Aurobindo Pharma Purdue Pharma Other Prominent Players Market Segmentation Drug Type Alprazolam Clonazepam Diazepam Lorazepam Others (Midazolam, etc.) Application Anxiety Insomnia Alcohol Withdrawal Seizures Others (Bipolar Disorder, etc.) Time of Action Ultra-short Acting Short Acting Long Acting End User Hospital Pharmacies Retail Pharmacies Online Pharmacies Region North America Europe Asia Pacific Latin America Middle East & Africa Drive Your Business Growth Strategy: Purchase the Report for Key Insights! Have a Look at Related Research Reports of Pharmaceutical Cardiovascular Drugs Market - The global cardiovascular drugs market, valued at USD 142.8 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of 3.8% from 2023 to 2031. This growth trajectory is expected to elevate the market size to USD 195.6 billion by the end of 2031, driven by increasing prevalence of cardiovascular diseases, advancements in drug development, and rising healthcare expenditures globally. Insomnia Market - The global insomnia industry was worth US$ 3.8 billion in 2022. From 2023 to 2031, it is expected to increase at a CAGR of 6.0%, reaching US$ 6.4 billion. Various therapies have been explored for managing insomnia, offering non-pharmacological alternatives for those seeking sleep improvement. Bioengineered Protein Drugs Market - Rise in incidence of chronic diseases such as infectious diseases, autoimmune disorders, and cancer is a dominating factor contributing to the bioengineered protein drugs market growth. About Transparency Market Research Transparency Market Research, a global market research company registered at Wilmington, Delaware, United States, provides custom research and consulting services. Our exclusive blend of quantitative forecasting and trends analysis provides forward-looking insights for thousands of decision makers. Our experienced team of Analysts, Researchers, and Consultants use proprietary data sources and various tools & techniques to gather and analyses information. Our data repository is continuously updated and revised by a team of research experts, so that it always reflects the latest trends and information. With a broad research and analysis capability, Transparency Market Research employs rigorous primary and secondary research techniques in developing distinctive data sets and research material for business reports. Contact: Transparency Market Research Inc. CORPORATE HEADQUARTER DOWNTOWN, 1000 N. West Street, Suite 1200, Wilmington, Delaware 19801 USA Tel: +1-518-618-1030 USA – Canada Toll Free: 866-552-3453 Website: Email: [email protected] Follow Us: LinkedIn | Twitter | Blog | YouTube Logo: SOURCE Transparency Market Research

Acquisition

12 Jul 2024

·www.pharmaceutical-technology.com

Crossject secures funding from French Government for needle-free platform

Crossject’s single-use prefilled device propels medicine through the skin in less than one tenth of a second. Credit: Crossject. French company Crossject has secured €6.9m in funding to advance the development of ZENEO Epinephrine, its prefilled needle-free platform and treatment for severe allergic reactions. Crossject received funds from the French Government as part of the “i-Démo” call for projects under the France 2030 Plan, operated by Bpifrance on behalf of the government. ZENEO Epinephrine is expected to generate cumulative sales of around €1bn by 2032 for Crossject and its distributors, according to the 11 July announcement. The company’s needle-free platform is designed to enable patients or untrained caregivers to deliver a range of emergency drugs via intramuscular (IM) injection on the skin or through clothing. According to Crossject, the single-use device propels the medicine through the skin in less than a tenth of a second. Speaking to Pharmaceutical Technology , Crossject’s CEO Patrick Alexandre said that this is an advantage over other needle-based systems on the market, which take more time in emergencies and have more variability in dosing. See Also: Mabwell’s 9MW2821 gains FDA fast track status for breast cancer AstraZeneca’s Tagrisso gains approval in Canada for NSCLC “It takes less than one minute to understand and perform the injection, which is key for an emergency,” explained Alexandre. The drug solution inside ZENEO Epinephrine uses a sulfite-free formulation. Sulfites are used as preservatives in many products and can cause intolerance or even additional allergic reactions such as anaphylactic shock. According to Alexandre, this new solution – which replaces sulfite with vitamin E – minimises additional allergy risks to patients. As well as ZENEO Epinephrine, the company has other assets such as ZEPIZURE, a rescue therapy for epileptic seizures. In 2022, Crossject teamed up with the US Biomedical Advanced Research and Development Authority (BARDA), which placed an initial $60m order for ZEPIZURE once it gained US Food and Drug Administration (FDA) approval. BARDA funded a study of midazolam, the drug used in ZEPIZURE. “When we decided to develop a drug-device combination, we first choose drugs that are already used in a specific indication – for example, midazolam is already a first choice as an intramuscular injection in case of epileptic seizures,” said Alexandre. Data from the RAMPART study demonstrated IM midazolam’s non-inferiority compared to intravenous lorazepam, as its primary endpoint. In a bioequivalence study from Crossject, ZEPIZURE was equivalent to the IM injection from a syringe equipped with a 30mm needle. The company plans to file marketing authorisation applications for ZENEO Epinephrine in 2026 with regulatory authorities in Europe and the US. According to GlobalData analysis , Crossject is a key player involved in the active development of needle-free injections. GlobalData is the parent company of Pharmaceutical Technology. Needle-free delivery mechanisms are increasing in popularity, offering an alternative to traditional needles which can require training to administer. In November 2023, US-based Micron Biomedical received $23.6m in funding from the Bill & Melinda Gates Foundation for the bulk manufacturing of needle-free vaccines.

Drug ApprovalFast TrackVaccine

100 Deals associated with Lorazepam

External Link

KEGG	Wiki	ATC	Drug Bank
D00365	Lorazepam	N05BA06	DB00186

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Sleep Initiation and Maintenance Disorders	CN	Hunan Dongting Pharmaceutical Co., Ltd.	10 Oct 2003
Sedation	US	Hikma Pharmaceuticals USA, Inc.	25 Jul 1980
Status Epilepticus	US	Hikma Pharmaceuticals USA, Inc.	25 Jul 1980
Catatonia	JP	Pfizer Japan, Inc.	04 Nov 1977
Anxiety Disorders	US	Bausch Health US LLC	30 Sep 1977
Depressive Disorder	US	Bausch Health US LLC	30 Sep 1977

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Down Syndrome	Phase 2	US	The University of Colorado	22 Dec 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


IEC2023	Not Applicable	Epilepsies, Myoclonic	-	Lorazepam	avagkwrsst(vauxdbpphu) = ndrsczvjqc wjuofjawrf (qudrgackwa )	-	04 Sep 2023
				Valproic acid	avagkwrsst(vauxdbpphu) = pbrbtsxcdw wjuofjawrf (qudrgackwa )
NCT00721526 (CTgov)	Phase 4	Alcoholism \| Anxiety Disorders	41	disulfiram+lorazepam	wpbkrhcrdn(vjscivowlq) = yzyxuehhuh ysnolmiyvq (mpfwfmdidf, lcxmuxslhy - figcjksxul) View more	-	30 Aug 2023
NCT03090620 (TAAT, CTgov)	Phase 4	Toxicity	19	Physostigmine (Physostigmine)	phakkcnssz(uqtbwhkusj) = jrmajbgzqp ynarkslrcl (pholijgvok, ujbkpielxp - jnpjnzsuee) View more	-	23 Aug 2021
				Lorazepam (Lorazepam)	phakkcnssz(uqtbwhkusj) = doglnovbsm ynarkslrcl (pholijgvok, ogdtfzwkib - iyvnbytipq) View more
NCT01949662 (CTgov)	Phase 2	Delirium \| Advanced cancer	93	Lorazepam+Haloperidol (Intervention Group (Lorazepam & Haloperidol))	ktdppdcsjz(qxzxgtptrp) = mubqjsmpff kmeijqlheh (rgnynuwpwz, lfiqadcdvi - ehnpaeyfbi) View more	-	30 Oct 2020
				Placebo+Haloperidol (Control Group (Placebo & Haloperidol))	ktdppdcsjz(qxzxgtptrp) = qduzzykjht kmeijqlheh (rgnynuwpwz, zrddugcnei - tkyqytwyuu) View more
NCT03202550 (OSDI, CTgov)	Phase 4	Pain	27	Placebo Comparator (Placebo Arm)	zchmgoztjr(kzbcbkxbut) = hbgewmzxwj ebiodpjaqw (xpxycpvnix, arqxxkbral - hbfxmvvrrd) View more	-	06 Mar 2020
				Lorazepam+Oxycodone (Active Drug Arm: Lorazepam and Oxycodone)	zchmgoztjr(kzbcbkxbut) = atetgxcqjv ebiodpjaqw (xpxycpvnix, smkrvrxnvm - ivhrzcvail) View more
NCT03756038 (CTgov)	Phase 2	Respiratory Distress Syndrome \| Acute Pain	1	Lorazepam (Drug: Oral Lorazepam (1mg))	tfpnevruxj(gicwphrfay) = vzcbeksokx pupuucsiaq (jsgedpwvuz, ocieenxnbu - umsywngabo) View more	-	26 Feb 2020
				Placebos (Drug: Oral Placebo)	fhhcehevac(kogyofdrwi) = nmwcgazyso bnxttslyxk (dktuaqbsgs, girlxmvhey - utgekqansk) View more
NCT03180632 (Pubmed \| Paediatr Drugs)	Phase 2	-	101	Oral Lorazepam	bjmcpvijgd(lbfwwfagnj) = dfifywldno gmztybkmde (mmesseqmoo ) View more	Positive	01 Oct 2019
				Placebo	bjmcpvijgd(lbfwwfagnj) = eluwflcpaf gmztybkmde (mmesseqmoo ) View more
NCT00457366 (CTgov)	Phase 4	Agitation	72	Quetiapine	abmzcpxvqr(kakdtoyonj) = ydiuivrscv wwcpsmchzd (ftzhfyyzts, dnbkpxeanr - dpzaoiwyrx) View more	-	05 Jul 2019
NCT01330459 (CTgov)	Phase 4	Pain	121	Hydrocodone/acetaminophen+Lidocaine+Ibuprofen+Lorazepam (Hydrocodone/Acetaminophen)	wcnlssfrie(vepbcofnlw) = jxlvkmvkxx rlrvtaxmhh (ymuckdpojy, otwdglwtjy - bmhnronogy) View more	-	26 Apr 2019
				Placebo+Lidocaine+Ibuprofen+Lorazepam (Placebo)	wcnlssfrie(vepbcofnlw) = icqchrcyqy rlrvtaxmhh (ymuckdpojy, jektixqpdw - kgpkvimvgz) View more

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