Acorda Therapeutics ($ACOR) posted positive results of its first clinical feasibility study of its diazepam nasal spray to treat patients with epilepsy.
Acorda focused on pharmacokinetics, safety and tolerability in its nasal treatment for epileptic patients who experience cluster seizures, or acute repetitive seizures, according to the company. Epilepsy is a neurological condition that affects mental and physical functions, and of the CDC-estimated 2.3 million U.S. adults with the condition, as many as 175,000 experience these clusters.
The New York-based company plans to submit an NDA for the spray to the FDA later this year.
The results showed that the benzodiazepine drug diazepam, when absorbed in the nasal cavity, was well tolerated and consistent with the safety profile of other diazepam treatments. The most common side effects, which resolved over time, were an altered sense of taste and nasal discomfort, experienced by about a quarter of patients, the company said.
"Diazepam nasal spray offers a therapeutic alternative that can be administered rapidly and conveniently," said Acorda Chief Medical Officer Enrique Carrazana in a statement.
The company announced the results at the International Congress of the International League Against Epilepsy in Montreal, Canada.
"The study results showed that the diazepam nasal spray pharmacokinetics are comparable whether it is administered during or immediately following a seizure," Carrazana said. "For people with epilepsy who experience cluster seizures, it is critical that treatment be administered as soon as a cluster is recognized to prevent additional seizure activity."
- here's the release