Acorda Therapeutics Inc (ACORQ)

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7:01AM Acorda Therapeutics announces Diazepam Nasal Spray demonstrates comparable bioavailability to diazepam rectal gel in pharmacokinetic study (ACOR) 30.18 : Co announces data from a Phase 1 study that showed a single dose of 20 mg Diazepam Nasal Spray had comparable plasma bioavailability to 20 mg of diazepam rectal gel. Diazepam Nasal Spray is being developed for the treatment of people with epilepsy who experience cluster seizures, also known as acute repetitive seizures.

This was an open-label crossover study conducted in 24 healthy volunteers, who received a single dose of 20 mg diazepam nasal spray and a single dose of 20 mg diazepam rectal gel. Both the nasal spray and rectal gel were generally well tolerated and showed similar safety profiles, with mild nasal and pharyngeal irritation more frequently observed with the nasal spray.

Acorda plans to submit a 505(b)(2)-type NDA for Diazepam Nasal Spray to the FDA in 2013 and rely upon FDA's previous findings of safety and efficacy for the reference listed drug, diazepam rectal gel. The Company has completed three pharmacokinetic studies of Diazepam Nasal Spray that will be included in the NDA submission.