Plumiaz Approval Status
- FDA approved: No
- Brand name: Plumiaz
- Generic name: diazepam
- 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 its bioequivalence to Diastat® rectal gel, needed 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|
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