Acorda bags development of PLUMIAZ for epilepsy seizures after lagging Diastat in clinical studies; shares off 3% premarket

• Acorda Therapeutics (NASDAQ:ACOR) pulls the plug on developing PLUMIAZ (diazepam) Nasal Spray for the treatment of seizure clusters in patients with epilepsy. Its decision was based on ongoing clinical studies that failed to demonstrate the product candidate's bioequivalence to Valeant Pharmaceuticals' (VRX) Diastat AcuDial (diazepam rectal gel), a requirement for the refiling of the New Drug Application (NDA). The specific issue was lower-than-expected mucosal absorption of diazepam in epileptics compared to studies in healthy volunteers.
• The company is in communication with investigators to discontinue all clinical trials and will assist in the transition of study participants. The data will be presented as a future medical conference.
• Acorda originally submitted its NDA in 2013 but received a Complete Response Letter (CRL) in May 2014 citing the need for three more clinical trials. Its plan was to refile the NDA in Q1 2017.
• Shares are down 3% premarket on average volume.
• Previously: Acorda Therapeutics projects Plumiaz NDA filing in early 2017 (May 27, 2015)