WASHINGTON, D.C.— Acorda Therapeutics, Inc. announced May 20 it will discontinue development of PLUMIAZ™ (diazepam) Nasal Spray, an investigational therapy which was being studied for the treatment of seizure clusters in people with epilepsy. Data from ongoing clinical trials do not demonstrate its bioequivalence to Diastat® gel, which is needed for New Drug Applications (NDA).
January 17, 2019
FDA Approves First Generic Version of Sabril to Help Treat Seizures in Adults and Pediatric Patients with Epilepsy
“Prioritizing the approval of generic drugs to compete with medicines that face little or no competition is a key part of our efforts to support access and reduce drug costs to patients,” said FDA Commissioner Scott Gottlieb, MD.
January 16, 2019
New Review Study Supports Ability of Epidiolex to Reduce Seizure Frequency in Dravet, Lennox-Gastaut Patients
Researchers in this study reviewed the main findings of these trials regarding the safety, efficacy, and tolerability of Epidiolex for the treatment of children with Dravet and Lennox-Gastaut syndromes.