Acorda Therapeutics is discontinuing development of Plumiaz (diazepam) nasal spray, the company has announced. Data from ongoing clinical trials do not demonstrate bioequivalence to Valeant's Diastat rectal gel. This was a requirement to re-file the New Drug Application (NDA) under section 505(b)(2).
The drug was in development for the treatment of seizure clusters in patients with epilepsy.
Plumiaz data showed unexpectedly lower nasal mucosa absorption of diazepam in persons with epilepsy compared to studies in healthy volunteers. The compound was granted orphan drug status from the FDA in July 2012, and Acorda submitted an NDA in 2013.
But in May 2014, the FDA issued a response letter, informing Acorda the application could not be approved in its present form.
"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.
Acorda Therapeutics, based in Ardsley, New York, develops drugs to improve therapies that improve neurological function in people with multiple sclerosis, spinal cord injury and other disorders of the central nervous system.
The company had planned to resubmit its NDA for Plumiaz in the first quarter of 2017. Acorda is now in communication with study investigators to discontinue all ongoing clinical trials and assist in the transition of study participants.
The company's 2014 acquisition of Civitas Therapeutics still leaves the inhalable Parkinson's disease drug CVT-301, which Acorda has said it expects to file an application for approval for in 2017.