Business
Aquestive Therapeutics Provides Business Update and Announces Chief Medical Officer Appointment
Submitted NDA for Libervant™ (diazepam) Buccal Film for treatment of seizure clusters in patients between two and five years of ageAppointed Carl N. Kraus,
About this update from Aquestive Therapeutics, Inc.
[{"type":"text","content":"Submitted NDA for Libervant™ (diazepam) Buccal Film for treatment of seizure clusters in patients between two and five years of ageAppointed Carl N. Kraus, M.D. as Chief Medical Officer WARREN, N.J., June 29, 2023 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (the “Company” or “Aquestive”), a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, today provided an update on recent business developments and announced the appointment of Carl N. Kraus, M.D. as Chief Medical Officer of the Company. NDA Filing for Libervant for Pediatric PopulationAquestive submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of Libervant™ (diazepam) Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) in patients between two and five years of age. The Company received tentative approval for Libervant for the treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) in patients 12 years of age and older in August 2022, but is currently under an orphan drug block to market access until January 2027. Diastat® (diazepam) Rectal Gel is the only treatment currently available to this patient population for this indication. The Company expects to hear from the FDA on the acceptance of, and issuance of a target action date on, this pediatric NDA within approximately two months. “We are hopeful that this important subpopulation may benefit from Libervant in the near term,” said Daniel Barber, Chief Executive Officer of Aquestive. “While there is inherent unpredictability in the orphan drug review process, we believe in patient choice and will continue to advocate for patient access to meaningful innovation across all age groups.” Chief Medical Officer Appointment“I am very pleased to welcome Carl to the Aquestive team. He brings over two decades of experience in drug development, ranging from discovery through late stage development, as well as a significant medical background,” said Mr. Barber. “His extensive clinical development experience will be invaluable in advancing the Anaphylm® development program as we plan to s...