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.
“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,” said Ron Cohen, M.D., Acorda’s President and CEO. “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.”
Acorda is in communication with study investigators to discontinue all ongoing clinical trials and assist in the transition of study participants. The Company will present the data at a future medical meeting.
About Acorda Therapeutics
Founded in 1995, Acorda Therapeutics is a biotechnology company focused on developing therapies that restore function and improve the lives of people with neurological disorders.
Acorda has an industry leading pipeline of novel neurological therapies addressing a range of disorders, including Parkinson’s disease, post-stroke walking difficulty, migraine, and multiple sclerosis. Acorda markets three FDA-approved therapies, includingAMPYRA® (dalfampridine) Extended Release Tablets, 10 mg.
For more information, please visit the Company’s website at: www.acorda.com.
Jeff Macdonald, (914) 326-5232