Acorda halts development of Plumiaz for epilepsy seizure clusters

23 May 2016

Acorda Therapeutics (Nasdaq: ACOR) announced on Friday that it will discontinue development of Plumiaz (diazepam) nasal spray, an investigational therapy being studied for the treatment of seizure clusters in people with epilepsy.

Data from the ongoing clinical trials do 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.

Acorda has previously received a complete response letter from the US Food and Drug Administration related to its New Drug Application for Plumiaz (The Pharma Letter May 2, 2014).

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