Aquestive submitted a citizen petition to the FDA urging the agency to delay approval of Neurelis’ new drug application for its cluster seizure nasal spray Valtoco (diazepam intranasal solution) pending additional clinical studies.
Neurelis submitted an NDA for the emergency nasal spray in Sept. 2018 as a treatment for epilepsy patients aged six years and older that experience cluster seizures. The drug is a proprietary formulation of diazepam with a vitamin E-based solution and an absorption enhancer.
Aquestive asked the agency to require a bridging study that compares Valtoco’s pharmacokinetics with the reference product Diastat (diazepam rectal gel) for the requested indication. It also called for a food effect study for the nasal spray.
Aquestive’s own seizure cluster drug in development, Libervant (buccal oral film), has already undergone food effect studies and a patient crossover study comparing it to Diastat. The company submitted a rolling NDA for Libervant with the FDA in May.