7:02AM Acorda Therapeutics announces first study of diazepam nasal spray in people with epilepsy shows feasibility of dosing during seizure - diazepam was well absorbed (ACOR) 31.72 : Co 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 and International Bureau for Epilepsy, 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.
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.
Acorda plans to submit a 505-type New Drug Applicationfor Diazepam Nasal Spray to the FDA in 2013 and rely upon FDA's previous findings of safety and efficacy for diazepam rectal gel.
