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Aquestive Therapeutics Announces U.S. Food and Drug Administration Filing Acceptance of New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film
FDA Acceptance of Libervant™ (diazepam) Buccal Film NDA for Management of Seizure ClustersPotential for First Oral Diazepam-Based Therapy for Population of
About this update from Aquestive Therapeutics, Inc.
[{"type":"text","content":"FDA Acceptance of Libervant™ (diazepam) Buccal Film NDA for Management of Seizure ClustersPotential for First Oral Diazepam-Based Therapy for Population of 1.2 million Refractory Epilepsy PatientsAssigned Prescription Drug User Fee Act (PDUFA) Goal Date of September 27, 2020 WARREN, N.J., Feb. 10, 2020 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today that, as anticipated, the U.S. Food and Drug Administration (FDA) accepted the Company’s New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film for the management of seizure clusters. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of September 27, 2020. If approved by the FDA, Libervant will be the first oral diazepam-based therapy approved for management of seizure clusters in the population of 1.2 million refractory epilepsy patients. Libervant was designated by the FDA as an orphan drug in November 2016.\n “The FDA filing acceptance for Libervant is an important milestone in our mission to provide epilepsy patients with a broader array of treatment options, that represent major contributions to patient care,” said Keith J. Kendall, Chief Executive Officer of Aquestive. “Aquestive is committed to helping people affected by seizure clusters through bringing important and innovative products to the market. Epilepsy patients have been underserved for some time with little choice beyond device-based products such as rectally administered gels and nasal sprays. We believe that our drug candidate Libervant will, if approved by the FDA, represent a major contribution to patient care, as compared to available treatment options, and further expand patient choice as the first orally administered dosage form available to manage seizure clusters in epilepsy patients.” “The FDA has recently indicated that, when evaluating clinical superiority for drugs demonstrating a ‘major contribution to patient care,’ it may consider such factors as convenience of treatment location, duration of treatment, patient comfort, reduced treatment burden, advances in ease and comfort of drug administration, longer periods between doses, and potential for self-administration,” contin...