Acorda Therapeutics announced 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. Both the nasal spray and rectal gel were generally well tolerated and showed similar safety profiles. Acorda plans to submit a 505(b)(2)-type New Drug Application 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.
- Pharmaceuticals & Drug Trials
- Acorda Therapeutics
- Nasal Spray