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# Aquestive Therapeutics Rolling NDA for Libervant
- URL: https://www.fdaweb.com/aquestive-therapeutics-rolling-nda-for-libervant/
- Published: 2019-12-03T12:00:00.000Z
- Updated: 2026-09-14T15:55:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145637

Aquestive Therapeutics has completed a rolling NDA submission for Libervant (diazepam) Buccal Film for managing seizure clusters. Libervant is administered from inside the cheek in selected, refractory patients with epilepsy on stable regimens who require intermittent use of diazepam to control bouts of increased seizure activity.

Aquestive says it is developing Libervant as an alternative to Valeant Pharmaceuticals’ Diastat (diazepam rectal gel), the current standard of care rescue therapy for patients with refractory epilepsy. “It is anticipated that Libervant will enable a larger share of these patients to receive more appropriate treatment by providing consistent therapeutic dosing in a non-invasive and innovative treatment form for epileptic seizures,” the company says.