Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Acorda Therapeutics said it will stop the development of its Plumiaz (diazepam) Nasal Spray for the treatment of epilepsy seizure clusters due to disappointing data from ongoing clinical trials.
Subscribe to our email newsletter
Plumiaz failed to demonstrate its bioequivalence to Diastat rectal gel, which was required to support a refiling of the nasal spray’s new drug application earlier planned for the first quarter of 2017.
The company said the data showed unexpectedly lower nasal mucosa absorption of diazepam in persons with epilepsy compared to studies in healthy volunteers.
Acorda Therapeutics president and CEO Ron Cohen said: "We are very disappointed by this outcome, and for those in the epilepsy community who experience 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."
Acorda is working with study investigators to discontinue all ongoing clinical trials and assist in the transition of study participants. The company added that it will present data from the trials at an unspecified future medical conference.
Acorda has a pipeline of novel neurological therapies addressing a range of disorders such as Parkinson’s disease, post-stroke walking difficulty, migraine, and multiple sclerosis.
The company markets three FDA-approved therapies, including Ampyra (dalfampridine) Extended Release Tablets, 10 mg.