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Aquestive Therapeutics Announces FDA Acceptance of New Drug Application (NDA) Resubmission for Libervant™ (diazepam) Buccal Film
Prescription Drug User Fee Act (PDUFA) Target Goal Date set for December 23, 2021If approved by the FDA for U.S. market access, Libervant would be the first
About this update from Aquestive Therapeutics, Inc.
[{"type":"text","content":"Prescription Drug User Fee Act (PDUFA) Target Goal Date set for December 23, 2021If approved by the FDA for U.S. market access, Libervant would be the first orally delivered diazepam product for the management of seizure clusters WARREN, N.J., July 19, 2021 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the resubmission of the 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”) target goal date of December 23, 2021. “We are pleased with the FDA’s decision to accept for review the Libervant NDA. We believe this underscores the unmet need in the underserved population of refractory epilepsy patients for a non-invasive and innovative product for the management of seizure clusters,” stated Keith Kendall, Chief Executive Officer of Aquestive. “We are preparing for the commercial launch of Libervant, if approved for U.S. market access, in the first half of 2022 and remain committed to fill this unmet need and improve the quality of life for patients suffering from this disease with this first of its kind treatment option.\" Aquestive received a Complete Response Letter (CRL) from the FDA in September 2020, completed a Type A meeting with the FDA in November 2020 and received further guidance from the FDA in February 2021. Based upon the Agency's guidance, the submission included additional statistical modeling and supporting analyses of the existing clinical data. The Company continues to believe that no additional clinical studies will be required for FDA approval of Libervant for U.S. market access. About LibervantThe Company believes that Libervant, if approved by the FDA for U.S. market access, will enable a larger share of patients to receive more appropriate treatment by providing consistent therapeutic dosing in a non-invasive and innovative treatment form for epileptic seizures. Libervant™ is a buccally, or inside of the cheek, administered soluble film formulation of diazepam, a benzodiazepine intended for rapid treatment of acute uncontrolled seizure...