Plumiaz Approval Status
- FDA approved: No
- Brand name: Plumiaz
- Generic name: diazepam
- Dosage form: Nasal Spray
- Company: Acorda Therapeutics, Inc.
- Treatment for: Epilepsy
Plumiaz (diazepam) is an investigational benzodiazepine nasal spray formulation in development for the treatment of epilepsy cluster seizures.
On May 20, 2016, Acorda Therapeutics, Inc. announced that it will discontinue development of Plumiaz (diazepam) Nasal Spray. Data from clinical trials did not demonstrate the bioequivalence to Diastat® rectal gel required to re-file the New Drug Application (NDA) under section 505(b)(2). Specifically, the data demonstrated unexpectedly lower nasal mucosa absorption of diazepam in persons with epilepsy compared to studies in healthy volunteers.
Development Status and FDA Approval Process for Plumiaz
|May 20, 2016||Acorda to Discontinue Development of Plumiaz for Treatment of Epilepsy Seizure Clusters|
|May 2, 2014||FDA Issues Complete Response Letter for Plumiaz for Epilepsy Cluster Seizures|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.