First Study of Diazepam Nasal Spray in People with Epilepsy Shows Feasibility of Dosing During Seizure

Acorda Therapeutics, Inc. ACOR today announced results of the first clinical study to assess pharmacokinetics, safety and tolerability of Diazepam Nasal Spray in people with epilepsy. Study findings were presented on June 25 at the biennial International Congress of the International League Against Epilepsy (ILAE) and International Bureau for Epilepsy (IBE), being held in Montreal, Canada. Diazepam Nasal Spray is being developed for the treatment of people with epilepsy who experience cluster seizures, also known as acute repetitive seizures. “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,” said Enrique Carrazana, M.D., Acorda's Chief Medical Officer. “Diazepam Nasal Spray offers a therapeutic alternative that can be administered rapidly and conveniently.” The study was an open-label, multi-center clinical trial, comprising 31 people with epilepsy who were admitted to epilepsy monitoring units. Each received a single dose of diazepam, administered as one spray in each nostril, during or immediately following a seizure. Blood levels of diazepam were measured serially for a period of up to 12 hours following the dose. Results showed that diazepam was well absorbed from the nasal cavity of people with epilepsy, had a similar pharmacokinetic profile regardless of when administered relative to the seizure episode and was well tolerated. The most common adverse events were related to the nasal route of delivery; most adverse events were mild and transient, and resolved within a day. Most common among these were an altered sense of taste and nasal discomfort, experienced by 26% and 23% of study subjects respectively. The overall safety and tolerability of Diazepam Nasal Spray in this study was consistent with the established safety profile of diazepam products. Acorda also presented the results of a separate study showing that Diazepam Nasal Spray and an equivalent dose of the rectal gel formulation of diazepam had comparable bioavailability in healthy volunteers. These data were previously presented at the 65th American Academy of Neurology Annual Meeting in March, 2013. Acorda plans to submit a 505(b)(2)-type New Drug Application (NDA) for Diazepam Nasal Spray to the U.S. Food and Drug Administration (FDA) in 2013 and rely upon FDA's previous findings of safety and efficacy for diazepam rectal gel.