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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 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, 2016Acorda to Discontinue Development of Plumiaz for Treatment of Epilepsy Seizure Clusters
May  2, 2014FDA Issues Complete Response Letter for Plumiaz for Epilepsy Cluster Seizures

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