FDA Accepts Aquestive NDA Resubmission

FDA has accepted for review an Aquestive Therapeutics NDA resubmission for Libervant (diazepam) Buccal Film for managing seizure clusters. The agency has set a 12/23 user fee review action target date.

After receiving a complete response letter 9/2020, Aquestive received feedback from FDA outlining a path to resubmit the NDA. The feedback addressed a revised weight-based dosing regimen, modeling and simulations data that Aquestive provided 12/2020, the company says.

Libervant is an inside-the-cheek-administered soluble film formulation of diazepam, a benzodiazepine intended for rapid treatment of acute uncontrolled seizures in selected, refractory patients with epilepsy on stable regimens of anti-epileptic drugs who require intermittent use of diazepam to control bouts of increased seizure activity. Aquestive is developing Libervant as an alternative to Diastat (diazepam rectal gel), the current standard of care rescue therapy for these patients.