Zonisamide

AZURITY PHARMACEUTICALS, INC. ANNOUNCES FDA APPROVAL OF ZONISADE™ (zonisamide oral suspension)

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Monday, July 18, 2022
University, University of Tennessee Health Science Center, CEO, Patient, Awareness, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Neurology, Association, Safety, Epilepsy, Depression, Azure Transit Connect Electric, Food, Zonisamide, United, Chair, Anxiety, Endocrinology, Caregiver burden, Brain, Pediatric Neurology, Multimedia, Tablet, Industry, Autism, Ageing, FDA, Learning, Pharmaceutical industry

WOBURN, Mass., July 18, 2022 /PRNewswire/ -- Azurity Pharmaceuticals, Inc., a private pharmaceutical company focused on developing innovative products to serve the specific needs of overlooked patients, today announced the U.S. Food and Drug Administration (FDA) approval of ZONISADE™ (zonisamide oral suspension),

Key Points: 
  • "ZONISADE is the first and only FDA-approved oral liquid formulation of zonisamide, and it offers healthcare providers an important new treatment option for their patients with epilepsy," said Richard Blackburn, CEO of Azurity Pharmaceuticals.
  • "We are excited about this approval as we continue to grow our portfolio of liquid medications that meet the individual needs of certain patients."
  • "ZONISADE addresses an important unmet need in patients who have difficulty swallowing or who are unable or unwilling to take tablets."
  • "The FDA approval and availability of ZONISADE is a welcomed advancement for patients and their families who may be seeking a liquid formulation alternative to treat epilepsy."

Eton Pharmaceuticals Reports Third Quarter Financial Results

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Monday, November 15, 2021
NDA, Cysteine, Safety, Carglumic acid, Private Securities Litigation Reform Act, Investor, Caregiver, EPS, R, Food, Security (finance), CEO, Research and development, Suspension, Degenerative disease, Growth, Goal, Administration, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, ID, Zonisamide, Adrenal insufficiency, NAGS, Partnership, Endocrinology, Conference, Topiramate, Securities and Exchange Commission (Philippines), Lamotrigine, Research, GLOBE, Therapy, Webcast, Tablet, Patient, FDA, Pharmaceutical industry, Lithium, Risk management, Video game

DEER PARK, Ill., Nov. 15, 2021 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today reported financial results for the third quarter ended September 30, 2021.

Key Points: 
  • DEER PARK, Ill., Nov. 15, 2021 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today reported financial results for the third quarter ended September 30, 2021.
  • These events put us in an even stronger position to deliver significant revenue and reach sustained profitability in 2022, said Sean Brynjelsen, CEO of Eton Pharmaceuticals.
  • The product will be marketed by Azurity Pharmaceuticals and is expected to be available before the end of the year.
  • Eton now has six FDA-approved products, three of which (carglumic acid, EPRONTIA, and Rezipres) are expected to launch in the fourth quarter of 2021.

Eisai to Divest Rights for Zonegran in Europe and Other Regions to Advanz Pharma

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Tuesday, June 15, 2021
Eisai, Anticonvulsants, Sodium channel blockers, Zonisamide, Advanz Pharma, Life sciences, Industry economics), Drugs

Under this agreement, Eisai will divest its rights associated with Zonegran in such European countries, the Middle East, Russia, and Australia to Advanz Pharma.

Key Points: 
  • Under this agreement, Eisai will divest its rights associated with Zonegran in such European countries, the Middle East, Russia, and Australia to Advanz Pharma.
  • Eisai will continue to act as the distributor in Russia, through its local affiliate Limited Liability Company Eisai, and Australia through its local affiliate Eisai Australia Pty.
  • Eisai will retain its rights to Zonegran in Canada, Mexico and Asian countries and continue to distribute the product in certain licensed Asian countries.
  • Eisai believes that this divestiture agreement with Advanz Pharma will lead to maximization of the antiepileptic agent's product value.

Eisai Receives Approval for Indication Expansion of Anti-Epileptic Agent Fycompa for Use in Pediatric Patients

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Monday, November 16, 2020
Neurological disorders, Health, Clinical medicine, Anticonvulsants, Eisai, Lennox–Gastaut syndrome, Sodium channel blockers, Epilepsy, GABAA receptor positive allosteric modulators, Rufinamide, Zonisamide

Study 232 evaluated the pharmacokinetics, efficacy, and long-term safety of Fycompa as an adjunctive therapy in pediatric patients with epilepsy (from 2 to less than 12 years of age).

Key Points: 
  • Study 232 evaluated the pharmacokinetics, efficacy, and long-term safety of Fycompa as an adjunctive therapy in pediatric patients with epilepsy (from 2 to less than 12 years of age).
  • As we offer several treatment options in Europe, including Fycompa, Eisai pursues its mission to provide "seizure freedom" to a greater number of patients with epilepsy.
  • Eisai is conducting a global Phase III clinical study (Study 338) for the agent in patients with seizures associated with Lennox-Gastaut syndrome.
  • For more information about Eisai Co., Ltd., please visit https://www.eisai.com
    Media Inquiries: Public Relations Department Eisai Co., Ltd. +81-(0)3-3817-5120
    Copyright 2020 JCN Newswire .

Sumitomo Dainippon Pharma Oncology Presents Findings from Phase 1 Clinical Study Evaluating Investigational Agent Dubermatinib in Patients with Advanced Solid Tumors at ESMO 2020 Virtual Annual Congress

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Friday, September 18, 2020
Sumitomo Group, Sumitomo Dainippon Pharma, Oncology, Pharmaceutical industry in China, Health, Companies, Anticonvulsants, Sunovion, Zonisamide

These results were presented during a mini-oral presentation at the European Society of Medical Oncology (ESMO) 2020 Virtual Annual Congress, being held September 19-21, 2020.

Key Points: 
  • These results were presented during a mini-oral presentation at the European Society of Medical Oncology (ESMO) 2020 Virtual Annual Congress, being held September 19-21, 2020.
  • The dose escalation portion of the study enrolled 45 patients with advanced solid tumors across 10 dose levels of dubermatinib monotherapy.
  • Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 6,000 employees worldwide.
  • A Phase 1, First-in-human, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral Dubermatinib (TP-0903) in Patients with Advanced Solid Tumors.

Eton Pharmaceuticals Submits New Drug Application to the FDA for Zonisamide Oral Suspension (ET-104)

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Thursday, July 30, 2020
Anticonvulsants, RTT, Sodium channel blockers, Organ systems, Carbonic anhydrase inhibitors, Drugs, Chemical compounds, GABAA receptor positive allosteric modulators, Lamotrigine, Topiramate, Zonisamide, Epilepsy in animals

Zonisamide is widely used as a capsule to treat partial seizures, but the molecule is not FDA approved in liquid form.

Key Points: 
  • Zonisamide is widely used as a capsule to treat partial seizures, but the molecule is not FDA approved in liquid form.
  • Based on IQVIA data, more than 150,000 prescriptions of zonisamide are written annually for the treatment of epilepsy.
  • ET-104 is one of Etons three neurology-focused liquid product candidates, along with ET-105 (lamotrigine oral suspension) and ET-101 (topiramate oral solution).
  • The companys lead pediatric product is the orphan drug Alkindi Sprinkle, which is currently under review with the FDA.