Aquestive Therapeutics receives FDA acceptance of NDA for Libervant

Aquestive Therapeutics announced acceptance by the U.S. Food and Drug Administration, FDA, of the Company’s NDA for Libervant Buccal Film in pediatric patients between two and five years of age and the assignment of a PDUFA goal date of April 28, 2024. Aquestive’s NDA for approval of Libervant Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity in patients between two and five years of age has been accepted by the FDA. Diastat Rectal Gel is the only treatment currently available to this patient population for this indication. The Company received tentative approval for Libervant for the treatment of intermittent, stereotypic episodes of frequent seizure activity in patients 12 years of age and older in August 2022, but Libervant is currently under an orphan drug block to market access until January 2027. “The FDA’s acceptance of our most recent filing for Libervant is another step forward in bringing this important treatment option to patients,” said Daniel Barber, Chief Executive Officer of Aquestive. “When it comes to the treatment of seizure clusters in pediatric patients with epilepsy five years of age and under, physicians and caregivers have limited options. We believe Libervant, as an oral alternative to existing device-based products, will be well-received by this patient population, if approved with market access.”