Acorda Therapeutics has announced that clinical trials of Plumiaz diazepam nasal spray have failed to demonstrate bioequivalence to Diastat rectal gel, which means that the company is unable to re-file its 505(b)(2) NDA for the product. The FDA had issued a complete response letter (CRL) for the NDA in 2014. As a result, the company says that it is discontinuing development of Plumiaz.
According to the announcement, the trial found that epilepsy patients absorbed less diazepam through the nasal mucosa than healthy volunteers absorbed.
Acorda President and CEO Ron Cohen commented, “We are very disappointed by this outcome, and for those in the epilepsy community who experience seizure clusters. I want to thank the many clinicians, caregivers, people with epilepsy and their families involved with the Plumiaz clinical studies for their efforts to advance care for people with seizure clusters. We will continue to focus on development of our other high potential pipeline programs, including CVT-301 and tozadenant for Parkinson’s disease, and dalfampridine for post-stroke walking difficulty.”
Plumiaz was licensed to Neuronex by SK Holdings in 2010, and Acorda subsequently acquired Neuronex in 2012. Acorda filed the 505(b)(2) NDA for the product in November 2013.
Read the Acorda press release.
