Acorda Therapeutics Inc. reported positive results in the first clinical study to assess the safe and effective use of the Ardsley company”™s diazepam nasal spray for epileptics with acute repetitive seizures.
In the U.S., up to 175,000 people with epilepsy experience cluster seizures despite being on stable regimens of antiepileptic drugs. Acorda is developing the spray product for that use and plans to submit a New Drug Application to the U.S. Food and Drug Administration this year.
Study findings were presented June 25 in Montreal, Canada, at the biennial International Congress of the International League Against Epilepsy and International Bureau for Epilepsy.
Dr. Enrique Carrazana, Acorda”™s chief medical officer, in a press release said study results showed that the diazepam nasal spray pharmacokinetics are comparable whether administered during or immediately following a seizure. For persons with cluster seizures, “It is critical that treatment be administered as soon as a cluster is recognized, to prevent additional seizure activity,” he said. “Diazepam nasal spray offers a therapeutic alternative that can be administered rapidly and conveniently.”
The clinical trial was conducted at multiple centers and included 31 people with epilepsy who were admitted to epilepsy monitoring units. .
Results showed that diazepam was well absorbed from the nasal cavity, had a similar pharmacokinetic profile regardless of when administered relative to the seizure episode and was well tolerated. The most common adverse events in patients were related to the nasal route of delivery, and most were mild and transient and resolved within a day.
The Centers for Disease Control and Prevention estimates that approximately 2.3 million adult Americans have active epilepsy.
Acorda Therapeutics is a biotechnology company focused on developing therapies that restore function and improve the lives of people with multiple sclerosis (MS), spinal cord injury and other neurological conditions. Its first commercial drug brands are Ampyra, used to improve walking in persons with MS, and Zanaflex, to treat spasticity in persons with MS and central nervous system injuries.
