Biotechnology company Acorda Therapeutics, Inc. has announced data from a phase I 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.
These pharmacokinetic data were presented at the 65th American Academy of Neurology Annual Meeting in San Diego, California.
“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,” said Enrique Carrazana, MD, Acorda’s chief medical officer. “This new mode of diazepam delivery can provide an important new treatment option for people with epilepsy and their caregivers.”
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 New Drug Application (NDA) for Diazepam Nasal Spray to the US Food and Drug Administration (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.
Epilepsy is a neurological condition that produces seizures affecting a variety of mental and physical functions. Seizures are symptoms of abnormal brain activity, and occur when a brief, strong surge of electrical activity affects part or all of the brain.
Acorda Therapeutics is focused on developing therapies that restore function and improve the lives of people with MS, spinal cord injury and other neurological conditions.