Acorda Therapeutics presented data from a Phase 1 study of its diazepam nasal spray at the American Academy of Neurology Annual Meeting this week showing that the plasma bioavailability of a 20 mg dose of diazepam nasal spray was comparable to that of a 20 mg dose of diazepam rectal gel. The company acquired the product, which is being developed for the treatment of cluster seizures in epilepsy patients, when it acquired Neuronex in 2012.
Acorda has previously announced that it plans to submit a 505(b)(2) NDA for the product in 2013 and says that it “rely upon FDA’s previous findings of safety and efficacy for the reference listed drug, diazepam rectal gel.”
Acorda Chief Medical Officer Enrique Carrazana commented, “Currently, the rectally-administered form of diazepam is the only FDA-approved outpatient therapy for people with epilepsy who experience cluster seizures. We believe that a nasal spray formulation offers a more accessible and socially acceptable therapeutic alternative dosage form for people with epilepsy. This new mode of diazepam delivery can provide an important new treatment option for people with epilepsy and their caregivers.”
Read the Acorda press release.
