FDA gives complete response for Plumiaz for Epilepsy-Acorda Therapeutics

The FDA has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for Plumiaz (diazepam Nasal Spray), from Acorda Therapeutics, for the treatment of people with Epilepsy who experience cluster seizures. Based on the requirements for approval outlined in the letter, the Company does not expect to receive FDA approval in 2014.

Acorda submitted a New Drug Application for Diazepam Nasal Spray to the FDA in Spetember 2013 and relied for evidence upon the FDA�s previous findings of safety and efficacy for diazepam rectal gel.