Acorda Presents New Data on Diazepam Nasal Spray at 67th Annual Meeting of American Epilepsy Society
Study found Diazepam Nasal Spray maintained consistent pharmacokinetic profile when administered during or immediately after seizure
ARDSLEY, N.Y.—Dec 9, 2013-- Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that new data from a pharmacokinetics study on Diazepam Nasal Spray found comparable pharmacokinetics (PK) whether the drug was administered during or immediately after a seizure. These data were presented at the 67th Annual Meeting of the American Epilepsy Society, in Washington, D.C. Diazepam Nasal Spray is being developed for the treatment of people with epilepsy who experience cluster seizures, also known as acute repetitive seizures.
“In this study, some patients received a dose of Diazepam Nasal Spray while having a seizure, while others received the dose after their seizure activity had ceased,” said Adrian Rabinowicz, M.D., FAAN, Acorda's Senior Vice President of Clinical Development and Medical Affairs. “The results suggest that delivery of Diazepam Nasal Spray was unaffected by the timing of dosage relative to seizure activity. It is critical for a person with epilepsy who experiences cluster seizures that treatment be administered as soon as possible after a cluster is recognized, in order to prevent additional seizure activity.”
This multicenter, open-label study was conducted in adults admitted to an epilepsy monitoring unit for evaluation and management of epilepsy. Of the 30 patients who completed the study, 10 were dosed during a seizure, while the other 20 patients were dosed after their seizure activity had ceased. Plasma concentrations of diazepam were measured for a period of up to 12 hours following the dose.
The overall safety and tolerability of Diazepam Nasal Spray in this study was consistent with systemic diazepam exposure established with other diazepam products. The most common local adverse events were related to the nasal route of delivery; most adverse events were mild and transient, and resolved within a day. These local events were an altered sense of taste and nasal discomfort, experienced by 26% and 23% of study subjects respectively.
Other data from this study were previously presented at the 30th biennial International Congress of the International League Against Epilepsy and International Bureau for Epilepsy.
Acorda has submitted a New Drug Application for Diazepam Nasal Spray to the U.S. Food and Drug Administration (FDA) and will rely upon the FDA’s previous findings of safety and efficacy for diazepam rectal gel.
About Epilepsy and Cluster Seizures/Acute Repetitive Seizures
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.
Of the approximately 2.75 million people in the United States with epilepsy, it is estimated that about 175,000 experience cluster seizures. Cluster seizures, also known as acute repetitive seizures, are characterized by recognizable, recurring episodes of seizure clusters.