Acorda announced that the FDA has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for Plumiaz (diazepam) Nasal Spray for the treatment of patients with epilepsy who experience cluster seizures.
According to the requirements outlined in the complete response letter, Acorda does not expect Plumiaz to receive FDA approval in 2014.
In July 2012, the FDA had granted Plumiaz Orphan Drug Designation for the management of selected, refractory patients with epilepsy currently on stable regimens of antiepileptic drugs (AEDs), who require intermittent use of diazepam to control bouts of increased seizure activity. Acorda submitted a NDA for Plumiaz to the FDA for review in 2014.
For more information call (800) 367-5109 or visit Acorda.com.