[Translation] A randomized, open-label, two-dose, single-dose, two-period, double-crossover bioequivalence study of sodium valproate oral solution in healthy subjects under fasting and fed conditions

主要研究目的：评价中国健康受试者在空腹和餐后条件下口服受试制剂丙戊酸钠口服溶液（40mL：8g）与对照制剂丙戊酸钠口服溶液（德巴金®）（300mL：12g）的药代动力学参数，进行两制剂的生物等效性分析。次要研究目的：观察丙戊酸钠口服溶液受试制剂和对照制剂在健康人群中的安全性。

[Translation]

The main purpose of the study is to evaluate the pharmacokinetic parameters of the test preparation of sodium valproate oral solution (40mL: 8g) and the control preparation of sodium valproate oral solution (Depakin®) (300mL: 12g) in Chinese healthy subjects under fasting and postprandial conditions, and to conduct bioequivalence analysis of the two preparations. The secondary purpose of the study is to observe the safety of the test preparation and control preparation of sodium valproate oral solution in healthy people.

Start Date07 Aug 2023

Sponsor / Collaborator

Shandong Dayin Oceanic Biochemicals Co. Ltd.

NCT04902105 / CompletedPhase 1

A Phase 1, Open-Label, Fixed Sequence, Drug-Drug Interaction Study to Evaluate the Effect of Inhibition of Uridine 5'-Diphosphate-glucuronosyltransferases (UGTs) on the Pharmacokinetics of Ecopipam Tablets and Its Active Metabolite (EBS-101-40853) in Healthy Subjects

This is a single center, open-label, fixed sequence, drug-drug interaction (DDI) study in healthy subjects.

Start Date13 May 2021

Sponsor / Collaborator

Emalex Biosciences, Inc.Startup

[+2]

CTRI/2020/02/023566 / Not yet recruitingPhase 1IIT

Quantitative Electroencephalography as a predictor of treatment Response to Divalproex sodium versus Lithium in Bipolar affective disorder

Start Date01 Mar 2020

Sponsor / Collaborator-

100 Clinical Results associated with Divalproex sodium

100 Translational Medicine associated with Divalproex sodium

100 Patents (Medical) associated with Divalproex sodium

985

Literatures (Medical) associated with Divalproex sodium

01 Dec 2023·Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie

Corrigendum to “Valproate, divalproex, valpromide: Are the differences in indications justified?” [Biomed. Pharmacother., 158 (2023) 114051]

Author: Bloch, Vanessa ; Chouchana, Margot ; Besson, Valérie C ; Hagenimana, Monique ; Palayer, Maeva ; Blaise, Nathan ; Delage, Clément ; Smati, Julie ; Etain, Bruno

01 Nov 2023·Journal of clinical psychopharmacology

Pleural Effusion Associated With Divalproex Sodium

Review

Author: Yuan, Haining ; Wang, Guishan ; Li, Jing ; Chen, Pei ; Yang, Yang ; Guo, Yumeng

20 Oct 2023·Archives of clinical neuropsychology : the official journal of the National Academy of Neuropsychologists

A - 46 Mild Neurocognitive Disorder Due to Multiple Etiologies Case Study.

Article

Author: Keaveney, Julie ; Felegy, Katelyn

OBJECTIVE:

Frank, a 68-year-old male, is seeking a neuropsychological evaluation based on a referral from the concussion legacy foundation. He wants to know if he has impairment and if so, what the cause is. He has been told by previous providers that he has Lewy Body Dementia, Alzheimer's Disease, or CTE.

METHOD:

Frank has had over 20 concussions from football, car accidents, and assaults. For approximately a year, Frank has noticed short-term memory loss, word-finding problems, difficulty concentrating, and forgetting things. Frank indicated his balance is poor, as he stumbles and falls 3-4 times/day. In 2022, Frank began having visual hallucinations. Frank's medical history includes diabetes, hypertension, and high cholesterol. He is prescribed Seroquel, Aricept, Depakote DR, Zoloft, Wellbutrin, and Prazosin.

RESULTS:

A test of premorbid functioning indicated Frank' abilities were in the Above Average range, which relative to his scores on this evaluation indicates a significant decline in cognitive functioning. There are significant impairments in Frank' auditory working memory, verbal learning and memory, visual learning and memory, visual planning and organization, and mental flexibility.

CONCLUSIONS:

Deficits are consistent with Mild Neurocognitive Disorder due to multiple etiologies. Possible etiologies include multiple concussions, vascular risk factors such as hypertension, high cholesterol, and diabetes, as well as possible degenerative brain changes. The data suggests deficits with attention, learning, retrieval, impulsivity, mental flexibility, which is consistent with frontal subcortical executive deficits. The pattern of findings is consistent with Lewy Body changes due to visual hallucinations, fluctuating cognition, motor symptoms, and dysexecutive patterns on testing.

News (Medical) associated with Divalproex sodium

10 Jul 2023

·www.biospace.com

Melinta Therapeutics Partners with BARDA to Advance Two FDA-Approved Antibiotics for Use in Pediatric Patients, and for Use Against Biothreat Pathogens

PARSIPPANY, N.J.--(BUSINESS WIRE)-- Melinta Therapeutics, LLC (Melinta), a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, announced today a partnership with the Biomedical Advanced Research and Development Authority (BARDA) to advance two antibiotics currently FDA-approved for adults, BAXDELA® (delafloxacin) and VABOMERE® (meropenem and vaborbactam), for use in pediatrics. In addition, Melinta and BARDA will partner on the development of BAXDELA® against biothreat pathogens. Under this contract, BARDA has awarded $20.5M for the base period, with the potential of additional funding of $121.4M, amounting to total funding up to $141.9M if all options are exercised. With this BARDA funding, Melinta aims to submit four supplemental New Drug Applications (sNDAs) for these new indications. BARDA is part of the U.S. Department of Health and Human Services’ Administration for Strategic Preparedness and Response. This partnership may enable BAXDELA® and VABOMERE® to be integrated into national preparedness efforts as well as pediatric care for multi−drug-resistant bacterial infections, enhancing sustained availability of the products, increasing end-user familiarity, and striving for availability for the US pediatric population. "I am thrilled and honored that BARDA and Melinta have agreed to partner for this important research marking a significant milestone in our journey toward becoming legendary for providing innovative therapies to people impacted by acute and life-threatening illnesses,” said Christine Miller, Melinta President and CEO. “This contract fuels our excitement to explore expanded applications of BAXDELA® and VABOMERE® through innovative research. We are poised to make a lasting impact in healthcare, unlocking new avenues for patient care and addressing unmet needs. We will drive progress and redefine what is possible, paving the way for a healthier future.” BAXDELA® (delafloxacin) is a novel fluoroquinolone (FQ), approved for adults in IV and oral tablet formulations to treat acute bacterial skin and skin structure infection (ABSSSI) and community-acquired bacterial pneumonia (CABP). CABP remains a leading cause of pediatric hospitalization and mortality in the US, with the highest incidence and morbidity in children under 2 years of age. The partnership with BARDA will support the BAXDELA® pediatric development plan to extend the adult CABP indication to children aged 2 months to less than 18 years. In addition, Melinta aims to advance BAXDELA® as a potential treatment option against biothreat pathogens for both adults and children. Given its broad spectrum of activity and availability in both IV and oral formulations, BAXDELA® can provide flexibility for use following a biothreat public health emergency, in varied care settings and across spectrums of disease severity. VABOMERE® is an approved combination of the carbapenem, meropenem, and the novel ß-lactamase inhibitor (BLI), vaborbactam. VABOMERE® was specifically designed to address gram-negative bacteria that produce beta-lactamase enzymes, including strains producing the Klebsiella pneumoniae carbapenemase (KPC) enzyme, the predominant form of carbapenem-resistant Enterobacterales (CRE) in the US. The CDC (Centers for Disease Control) classifies CRE as an “urgent” threat because there are few alternative antibiotics to treat CRE-infections. The VABOMERE® pediatric development plan will support the filing of sNDAs to extend the adult cUTI indication to children aged 3 months to less than 18 years and target the indication of late onset neonatal sepsis in children aged less than 90 days. “The ability to partner with BARDA on these important programs is exactly the type of work that brought me to Melinta and what excites me about the work we do,” said Douglas Girgenti, MD, VP, Head of Development and Clinical Operations, Melinta. “Pediatric clinical development of BAXDELA® and VABOMERE® will help inform drug safety and tolerability as well as determine optimal antibiotic dosing, with the ultimate goal of enabling use in pediatric cases and expanding the arsenal of healthcare providers in their fight to save lives. The potential addition of BAXDELA® to the biodefense armamentarium will likewise provide a much-needed option for public health emergencies in both children and adults.” 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; Biomedical Advanced Research and Development Authority, under contract number 75A50123C00022. About Melinta Therapeutics Melinta Therapeutics is a biopharmaceutical company dedicated to providing innovative therapies to people impacted by acute and life-threatening illnesses. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients. Our portfolio currently includes seven commercial-stage products: BAXDELA® (delafloxacin), KIMYRSA® (oritavancin), MINOCIN® (minocycline) for Injection, ORBACTIV® (oritavancin), REZZAYO™ (rezafungin for injection), TOPROL-XL® (metoprolol succinate) and VABOMERE® (meropenem and vaborbactam). For more information about Melinta Therapeutics, our commitment to patients, and to learn about our portfolio of therapies, visit Melinta.com. About BAXDELA® (delafloxacin) BAXDELA® is indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by the following susceptible microorganisms: Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates), Staphylococcus haemolyticus, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), Streptococcus pyogenes, and Enterococcus faecalis, Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, and Pseudomonas aeruginosa. BAXDELA® is indicated in adults for the treatment of community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible [MSSA] isolates only), Klebsiella pneumoniae, Escherichia coli, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, Chlamydia pneumoniae, Legionella pneumophila, and Mycoplasma pneumoniae. IMPORTANT SAFETY INFORMATION: WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS, and EXACERBATION OF MYASTHENIA GRAVIS Contraindications BAXDELA® is contraindicated in patients with known hypersensitivity to BAXDELA® or other fluoroquinolones. Warnings and Precautions Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions. Avoid use in patients who have experienced any of the following serious adverse reactions. If these reactions occur in patients receiving BAXDELA®, discontinue BAXDELA® immediately and institute appropriate treatment: Tendinitis, tendon rupture, with increased risk in elderly, patients taking corticosteroids and in patients with organ transplants Peripheral neuropathy, such as pain, burning, tingling, numbness, and/or weakness or other alterations of sensation in touch and/or motor strength Central nervous system adverse reactions such as seizures, increased intracranial pressure, dizziness, and tremors Exacerbation of myasthenia gravis, including death and requirement for ventilator Fluoroquinolones, including BAXDELA®, have been associated with an increased risk of psychiatric adverse reactions, including: toxic psychosis; hallucinations, or paranoia; depression, or suicidal thoughts or acts; delirium, disorientation, confusion, or disturbances in attention; anxiety, agitation, or nervousness; insomnia or nightmares; memory impairment. These adverse reactions may occur following the first dose. Hypersensitivity reactions have been reported in patients receiving fluoroquinolones, including BAXDELA®. Reactions can be serious and occasionally fatal (anaphylactic). Discontinue BAXDELA® at the first sign of hypersensitivity. Clostridium difficile-associated diarrhea has been reported with nearly all systemic antibacterial agents, including BAXDELA®, with severity ranging from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. Fluoroquinolones have been associated with an increased risk of aortic aneurysm and dissection, especially in elderly patients. In patients with a known aortic aneurysm or patients who are at greater risk for aortic aneurysms, reserve BAXDELA® for use only when there are no alternative antibacterial treatments available. Prescribing BAXDELA® in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Fluoroquinolones have been associated with disturbances of blood glucose, including symptomatic hyperglycemia and hypoglycemia. Severe cases of hypoglycemia resulting in coma or death have been reported with other fluoroquinolones. Monitor blood glucose carefully in diabetic patients receiving oral hypoglycemic agents or insulin. Discontinue BAXDELA® and initiate appropriate therapy immediately if a hypoglycemic reaction occurs. Adverse Reactions The most common adverse reactions in patients treated with BAXDELA® were nausea (8%), diarrhea (8%), headache (3%), transaminase elevations (3%), and vomiting (2%). Visit for the full Prescribing Information, including the Boxed Warning. About VABOMERE® (meropenem and vaborbactam) VABOMERE® is indicated for the treatment of patients 18 years of age and older with complicated urinary tract infections (cUTI) including pyelonephritis caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, and Enterobacter cloacae species complex. IMPORTANT SAFETY INFORMATION Contraindications VABOMERE® is contraindicated in patients with known hypersensitivity to any components of VABOMERE® (meropenem and vaborbactam), or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactam antibacterial drugs. Warnings and Precautions Hypersensitivity reactions were reported in patients treated with VABOMERE® in the clinical trials. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving therapy with beta-lactam antibacterial drugs. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe hypersensitivity reactions when treated with another beta-lactam antibacterial drug. If an allergic reaction to VABOMERE® occurs, discontinue the drug immediately. Seizures and other adverse Central Nervous System (CNS) experiences have been reported during treatment with meropenem, which is a component of VABOMERE®. Close adherence to the recommended dosage regimens is urged, especially in patients with known factors that predispose to convulsive activity. Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including VABOMERE, and may range in severity from mild diarrhea to fatal colitis. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. The concomitant use of VABOMERE® and valproic acid or divalproex sodium is generally not recommended. Case reports in the literature have shown that co-administration of carbapenems, including meropenem, to patients receiving valproic acid or divalproex sodium results in a reduction in valproic acid concentrations. The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore increasing the risk of breakthrough seizures. If administration of VABOMERE® is necessary, consider supplemental anticonvulsant therapy. In patients with renal impairment, thrombocytopenia has been observed in patients treated with meropenem, but no clinical bleeding has been reported. Alert patients receiving VABOMERE® on an outpatient basis regarding adverse reactions such as seizures, delirium, headaches and/or paresthesias that could interfere with mental alertness and/or cause motor impairment. Prescribing VABOMERE® in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of drug-resistant bacteria. As with other antibacterial drugs, prolonged use of VABOMERE® may result in overgrowth of nonsusceptible organisms. Adverse Reactions The most frequently reported adverse reactions occurring in ≥3% of patients treated with VABOMERE® were headache, phlebitis/infusion site reactions, and diarrhea. Visit for the full Prescribing Information.

Drug ApprovalLicense out/in

18 Aug 2022

·www.biospace.com

Jazz Takes Groundbreaking Epilepsy Drug into Kids in Phase III Trial

Jazz Pharma is breaking new ground with its cannabidiol epilepsy treatment Epidiolex, taking the drug into a Phase III study in children and adolescents. The study will include children and adolescents living with developmental and epileptic encephalopathy, known as epilepsy with myoclonic-atonic seizures (EMAS). In 2018, Epidiolex, developed by GW Pharmaceuticals, became the first cannabis-based drug approved by the FDA and required a reclassification by the U.S. Drug Enforcement Agency prior to commercialization. Epidiolex is derived from cannabidiol (CBD), a chemical component of the Cannabis sativa plant, more commonly known as marijuana. However, CBD does not cause the typical "high" associated with marijuana, as it does not include tetrahydrocannabinol (THC), the plant's main psychoactive compound. Epidiolex was approved by the FDA for the treatment of seizures associated with two rare forms of epilepsy: Lennox-Gastaut syndrome (LGS) and Dravet syndrome. Jazz Pharma acquired GW last year for $7.2 billion. Now, Jazz is aiming Epidiolex at EMAS, which is also known as Doose syndrome. EMAS typically begins in early childhood. It is a developmental and epileptic encephalopathy that is fairly uncommon, accounting for 1% to 2% of all childhood-onset epilepsies, according to the Epilepsy Foundation. The disease tends to occur in boys more often than girls and is associated with different types of seizures, including drop seizures, tonic seizures and myoclonic seizures, among others. Jazz noted that seizures in pediatric EMAS patients can be difficult to treat, and some of the children do not respond well to available medications. Currently available treatments for Doose syndrome include the anticonvulsants divalproex sodium, zonisamide, felbamate and others. According to the Epilepsy Foundation, some anticonvulsants can actually worsen the symptoms of EMAS patients. Rob Iannone, executive vice president, global head of research and development of Jazz Pharmaceuticals, pointed out that there are numerous treatment-resistant epilepsy syndromes. Because of that, epileptologists, neurologists who specialize in epilepsy treatment, typically look for efficacy by seizure type, he said. Iannone further noted that most of those types have no syndrome-specific approved treatment. “An EMAS indication would provide support for the use of Epidiolex in a fourth indication of a distinct, generalized seizure type, myoclonic-atonic seizures,” Iannone said in a statement. “Jazz is committed to continuing to generate clinical study data and real-world evidence to further support the utility of the company's cannabidiol across a broad range of difficult-to-treat seizure types.” The Phase III trial will assess Epidiolex over a 14-week treatment period in a randomized, double-blind, placebo-controlled study. The trial will consist of two parts and enroll pediatric and adolescent patients from the ages of 1 to 18. The first portion of the study will assess the efficacy and safety of cannabidiol compared to placebo as an adjunctive treatment for children and adolescents with myoclonic-atonic seizures. When that portion of the study is completed, the patients will have an option to continue in a 54-week open-label extension trial, Jazz said. Cannabis-based products are being assessed for multiple neurological indications. In addition to Epidiolex, Jazz is also developing Sativex, a cannabis-based drug approved in the United Kingdom for the treatment of multiple sclerosis. However, Sativex failed to reach key endpoints in a Phase III study in June. Other companies are also developing cannabis-based products, including Cara Therapeutics, Corbus Pharmaceuticals and Insys Therapeutics. A recent study published in the Journal of Clinical Psychiatry showed that cannabis-based treatments can significantly reduce anxiety, with cannabidiol reducing anxiety by 50% in young people aged 12-25 who have not responded well to other treatments. Some researchers are also assessing cannabidiol assets against the inflammation associated with COVID-19 infections.

15 Jun 2022

·www.prnewswire.com

Migraine Market to Progress at a CAGR of 10.96% by 2032 | DelveInsight

The migraine market is expected to surge due to the increasing prevalence of the disease along with increasing awareness during the forecast period. Furthermore, the launch of various multiple-stage pipeline products will significantly revolutionize the migraine market dynamics. LAS VEGAS, June 15, 2022 /PRNewswire/ -- DelveInsight's Migraine Market Insights report includes a comprehensive understanding of current treatment practices, Migraine emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM (the United States, the EU5 (the United Kingdom, Italy, Spain, France, and Germany), and Japan. Key Takeaways from the Migraine Market Report As per DelveInsight analysis, the migraine market size in the 7MM was approximately USD 6.9 billion in 2021. As per the estimates, the total Migraine prevalent cases in the 7MM was approximately 118 million in 2021. Leading Migraine companies such as Lundbeck Seattle BioPharmaceutical, Eli Lilly and Company, Amgen, Novartis, Teva Pharmaceuticals, Allergan, Biohaven Pharmaceuticals, Dr. Reddy's Labs, AbbVie, Impel NeuroPharma, Zosano Pharma, Axsome Therapeutics, Aeon Biopharma Inc., Ionis Pharmaceuticals, Inc., Charleston Laboratories , and others are developing novel migraine drugs which can be available in the migraine market in the upcoming years. The migraine therapies in the pipeline include BHV-3500 (Zavegepant), Atogepant, INP104, Zolmitriptan transdermal, AXS-07, Lu AG09222, ABP-450, IONIS-PKKRx, Oral CL- H1T, LY-3451838, and others. The increased number of migraine cases and the emerging treatment are likely to contribute directly to the migraine market growth during the forecast period. Discover more about therapies set to grab major migraine market share @ Migraine Market Landscape Migraine Overview Migraine is the seventh most debilitating disease in the world (responsible for 2.9% of all years of life lost to disability/YLDs) and the leading cause of impairment among all neurological disorders. Migraine is classed as chronic or episodic based on the type of the attack and its frequency. Episodic migraine is defined as having 0–14 headache days per month, and chronic migraine is defined as having 15 or more headache days per month. Although migraine symptoms usually include severe throbbing recurring pain on one side of the head, one-third of migraine attacks are found to be affected on both sides. Among the most common migraine causes include stress, physical factors, food additives, and others. MRI and CT scans are mainly used for migraine diagnosis. Migraine Epidemiology Segmentation As per DelveInsight, there were approx 118 million Migraine prevalent cases in the 7MM in 2021. Among the EU5 countries, Germany had the highest migraine prevalence in 2021. The Migraine market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Total Prevalence of Migraine Prevalent Cases of Migraine by severity Gender-specific Prevalence of Migraine Diagnosed Cases of Episodic and Chronic Migraine Download the report to understand which factors are driving migraine epidemiology trends @ Migraine Epidemiological Insights Migraine Treatment Market The key revenue-generating components of the acute migraine treatment market can be roughly characterized as triptans, NSAIDs, analgesics/opioids, and DHE (dihydroergotamine) or ergot alkaloids. Triptans continue to dominate the entire acute therapy landscape in terms of revenue generation. Some of the major migraine drugs (generics/branded) belonging to this class are eletriptan, almotriptan, sumatriptan, rizatriptan, zolmitriptan, and others. Moreover, preventive/prophylactic treatment is used to minimize the frequency, intensity, and duration of migraine attacks. Preventive migraine medicines approved by the FDA include propranolol, timolol, divalproex sodium, OnabotulinumtoxinA (botox), and topiramate; other drugs have demonstrated effectiveness but need FDA clearance. Apart from these, the other FDA approved drugs used for migraine treatment are Vyepti (Eptinezumab) (Lundbeck Seattle BioPharmaceutical), Emgality (Galcanezumab-gnlm) (Eli Lilly and Company), Aimovig (Amgen/Novartis), Ajovy (Teva Pharmaceuticals), Ubrelvy (Allergan), Rimegepant (Nurtec ODT) (Biohaven Pharmaceuticals), and others. To know more about migraine treatment, visit @ Migraine Medications Migraine Pipeline Therapies and Key Companies BHV-3500 (Zavegepant): Biohaven Pharmaceuticals Atogepant: AbbVie INP104: Impel NeuroPharma Zolmitriptan transdermal: Zosano Pharma AXS-07: Axsome Therapeutics Lu AG09222: Lundbeck ABP-450: Aeon Biopharma IONIS-PKKRx: Ionis Pharmaceuticals Oral CL- H1T: Charleston Laboratories LY-3451838: Eli Lilly and Company Learn more about the migraine medicine in clinical trials @ Migraine Treatment Migraine Market Dynamics The migraine treatment market looks promising as the market is emerging with newer treatments that have recently been approved by the FDA and are anticipated for approval in the coming years. A large number of clinical phase trials are being done to examine and evaluate promising investigational therapies and their much-awaited launch owing to a robust therapeutic treatment market and bolstering the treatment response as a whole. Moreover, the increasing disease prevalence and awareness will fuel the migraine market during the forecast period. However, some factors are hindering the growth of the migraine market. Despite the availability of standard treatment guidelines across regions and the well-entrenched presence of an array of available, mostly inexpensive options, current abortive and prophylactics, lack of biomarkers, and lack of therapies for pediatric patients exist as a high unmet need which is contrary to the popular perception. The therapies addressed in recent are not effective in all patients, have contraindications related to cardiovascular conditions in some patients, and are nonspecific or poorly tolerated in others. In addition, the undiagnosed, unreported cases and the unawareness about the disease remain the primary aspects that strive for the migraine market growth. Scope of the Migraine Market Report Study Period: 2019–2032 Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan] Key Migraine Companies: Lundbeck Seattle BioPharmaceutical, Eli Lilly and Company, Amgen, Novartis, Teva Pharmaceuticals, Allergan, Biohaven Pharmaceuticals, Dr. Reddy's Labs, AbbVie, Impel NeuroPharma, Zosano Pharma, Axsome Therapeutics, Aeon Biopharma Inc., Ionis Pharmaceuticals, Inc., Charleston Laboratories, and others Key Migraine Therapies: BHV-3500 (Zavegepant), Atogepant, INP104, Zolmitriptan transdermal, AXS-07, Lu AG09222, ABP-450, IONIS-PKKRx, Oral CL- H1T, LY-3451838, and others Therapeutic Assessment: Migraine current marketed and emerging therapies Migraine Market Dynamics: Migraine market drivers and barriers Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies Unmet Needs, KOL's views, Analyst's views, Migraine Market Access and Reimbursement Discover more about migraine drugs in development @ Migraine Clinical Trials Table of Contents Get in touch with our Business executive @ Healthcare Due Diligence Services Related Reports Migraine Epidemiology Migraine Epidemiology Forecast to 2032 report delivers an in-depth understanding of the disease, historical, and forecasted Migraine epidemiology in the 7MM. Migraine Pipeline Migraine Pipeline Insight, 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Migraine companies including Allergan, Biohaven Pharmaceuticals, Dr. Reddy's Labs, AbbVie, among others. Cluster Headache Market Cluster Headache Market Insights, Epidemiology, and Market Forecast-2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Cluster Headache companies including Eli Lilly and Company, Teva Pharmaceuticals, Novartis, among others. Cluster Headache Epidemiology Cluster Headache Epidemiology Forecast to 2032 report delivers an in-depth understanding of the disease, historical, and forecasted Cluster Headache epidemiology in the 7MM. Cluster Headache Pipeline Cluster Headache Pipeline Insight, 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Cluster Headache companies including Eli Lilly and Company, Teva Pharmaceuticals, Novartis, among others. Other Trending Reports Glomerulonephritis Market | Lymphedema Market | Audiology Devices Market | Campylobacter Infections Market | Varicose Veins Market | Nasolabial Fold Market | Reactive Airway Disease Market | Scleritis Market | Contrast-Induced Nephropathy Market | Mucinous cystic neoplasms Market | Metastatic Uveal Melanoma Market | ICOS-Next Generation Immunotherapy Market | Herpes Simplex Market | Hepatitis C Market | Guillain-Barre Syndrome Market | Graft Versus Host Disease Market | Goitre Market Related Healthcare Blogs Neuromodulation Devices in Migraine Migraine Treatment Market Migraine Market Outlook About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us on LinkedIn |Facebook|Twitter Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

Generic DrugImmunotherapy

100 Deals associated with Divalproex sodium

External Link

KEGG	Wiki	ATC	Drug Bank
D00304	Divalproex sodium	N03AG01	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Epilepsy	US	Teva Pharmaceuticals USA, Inc.	29 Jul 2008
Bipolar Disorder	US	AbbVie, Inc.	06 Dec 2005
Migraine Disorders	US	AbbVie, Inc.	04 Aug 2000
Epilepsy, Complex Partial	US	AbbVie, Inc.	10 Mar 1983
Seizures	US	AbbVie, Inc.	10 Mar 1983

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Alcohol-Related Disorders	Phase 3	US	Abbott Laboratories	01 Sep 2004
Alcoholism	Phase 3	US	Abbott Laboratories	01 Sep 2004
Bipolar I disorder	Phase 3	US	Abbott Laboratories	01 Jul 2004
Mania	Phase 3	US	Abbott Laboratories	01 Nov 1997
Substance Abuse	Phase 3	US	Abbott Laboratories	01 Nov 1997
Huntington Disease	Phase 2	US	National Institute of Neurological Disorders & Stroke	01 Oct 2004
Alzheimer Disease	Phase 2	US	National Institute of Neurological Disorders & Stroke	01 Jul 2004
Schizophrenia	Phase 2	US	Abbott Laboratories	01 Jul 2003
Disruptive, Impulse Control, and Conduct Disorders	Phase 2	US	National Institute of Mental Health	01 May 2003

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03012815 (CTgov)	Phase 4	Alcohol Abstinence	88	Divalproex Sodium+Gabapentin (Gabapentin)	afzlkyzrzp(oyfhindfjb) = xnojuuuezx dttmshnnhp (miyrsczodt, jeodyfaxqd - tpvgbydusc) View more	-	24 Mar 2022
				Benzodiazepines (Benzodiazepine)	afzlkyzrzp(oyfhindfjb) = uiuafqucfj dttmshnnhp (miyrsczodt, gdeomtirxb - mghddbfgpu) View more
NCT00579280 (CTgov)	Phase 4	Bipolar Disorder \| Anxiety \| Panic ... View more	224	quetiapine SR (Quetiapine SR)	kovlmzluyn(fwyurhlzcr) = rwsspuvzol gtmuypdrqp (faaojeozrk, ckrtujeggd - neabmmagrn) View more	-	11 Jun 2020
				divalproex sodium ER (Divalproex Sodium ER)	kovlmzluyn(fwyurhlzcr) = moodrifwis gtmuypdrqp (faaojeozrk, tmqxofarbz - ieiaivvtwv) View more
NCT00397020 (CTgov)	Phase 4	Bipolar Disorder	30	divalproex ER (1 Divalproex ER)	bccycbtxhx(mnomlpvazm) = psihklvdfb oamuprnmvd (yuasofufip, qnprcdwqba - hizufxomyk) View more	-	11 Sep 2019
				Quetiapine (2 Quetiapine Fumarate)	bccycbtxhx(mnomlpvazm) = qpeuxztmmz oamuprnmvd (yuasofufip, xxrhylfryt - nvtblxjhaf) View more
NCT00194116 (CTgov)	Phase 3	Bipolar Disorder	54	Divalproex Sodium ER (Divalproex Sodium ER)	ylybhgarrg(lrxxucwwyf) = olgihfnznt zkeodfbbxu (kyhrvnzufi, izhgmzlobj - lcutzotoff) View more	-	17 Jul 2019
				Placebo (Placebo)	ylybhgarrg(lrxxucwwyf) = yqmqwkvxne zkeodfbbxu (kyhrvnzufi, xxpkthmvmv - iokiqshvkk) View more
NCT00211757 (CTgov)	Phase 2	Autistic Disorder	27	Placebo (Placebo)	pzbtepvpsd(jyyutigjxq) = zytrokstfk qgqysfblhi (mnputsbfml, jtediemosk - rdycxcwndd) View more	-	06 Dec 2018
				Divalproex sodium (Divalproex Sodium)	pzbtepvpsd(jyyutigjxq) = mdzjdfmewg qgqysfblhi (mnputsbfml, synvzphmmk - bmpmdmdznn) View more
NCT00186186 (CTgov)	Phase 4	Bipolar Disorder	28	Depakote ER	deeqhsfzgh(jezrntthxv) = zlkyindgbk ntrhxoivjx (svjupgrkfa, nwfdisupms - jvpcrzuxki) View more	-	12 Apr 2017
NCT01760785 (CTgov)	Not Applicable	Alcoholism \| Brain Injuries, Traumatic	50	divalproex sodium (Divalproex Sodium)	qpabhjleci(wtrwnvsxjj) = cgtvhbgpgf ddpclrcsra (dgeqmccjzu, clqqvzaaki - vgacxfqaek) View more	-	15 Jun 2016
				Placebo (Sugar Pill)	qpabhjleci(wtrwnvsxjj) = cntonquwoi ddpclrcsra (dgeqmccjzu, sfbsxaejtu - tlstfbairy) View more
NCT00176202 (CTgov)	Phase 3	Bipolar Disorder	65	risperidone (Risperidone)	hviijhwtgj(tjwwzjpkve) = yohrykgjjz lexvndbhls (cnndousjte, cvbrejdnfe - krnfbliypd) View more	-	05 Nov 2015
				Divalproex Sodium (Divalproex Sodium)	gbtzskwcpt(xeuvmcqpty) = eglvdqrgbr wgmfuuvldi (tflfsnwyve, oyvmasvjju - cipkhqirix) View more
NCT00063362 (CTgov)	Phase 3	Bipolar Disorder	49	Divalproex+Lithium+Lamotrigine (Lithium + Divalproex + Lamotrigine)	mofxpfhbvo(nbsazndcwh) = mgawymhtoa kdoyqhcszf (yhclwfabdq, okvtvbaanw - jdcfwruycz) View more	-	30 Jan 2014
				Placebo+Divalproex+Lithium (Lithium + Divalproex + Placebo)	mofxpfhbvo(nbsazndcwh) = rnwepizxhb kdoyqhcszf (yhclwfabdq, anvwcyizzl - nnkarieldn) View more
NCT00203242 (CTgov)	Not Applicable	Cluster Headache	15	Depakote+Depacon IV	hwcwwwhosu(mbgvercjmp) = nlmzmocqrm rhwnwiywre (wduqpiqtbc, hyxofmzrjg - dwscxhxmal) View more	-	06 Jul 2011

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