Acorda Therapeutics announced results from a clinical study of the pharmacokinetics, safety, and tolerability of its diazepam nasal spray for the treatment of cluster seizures in epilepsy patients at the recent International Congress of the International League Against Epilepsy (ILAE) and International Bureau for Epilepsy (IBE).
Over the course of the study, 31 patients received a single dose of diazepam nasal spray either during or immediately after a seizure, and levels of diazepam in the blood were measured for up to 12 hours after dosing.
Acorda Chief Medical Officer Enrique Carrazana said, “The study results showed that the diazepam nasal spray pharmacokinetics are comparable whether it is administered during or immediately following a seizure. For people with epilepsy who experience cluster seizures, it is critical that treatment be administered as soon as a cluster is recognized, to prevent additional seizure activity. Diazepam nasal spray offers a therapeutic alternative that can be administered rapidly and conveniently.”
The company reiterated that it plans to submit a 505(b)(2) New Drug Application (NDA) for the product to the FDA in 2013.
Read the Acorda press release.
