Aquestive Therapeutics Receives U.S. FDA Approval and Market Access for Libervant (diazepam) Buccal Film in Pediatric Patients Ages 2 to 5 and Provides Update on Anaphylm (epinephrine) Sublingual Film

• Libervant is the first and only FDA approved orally administered rescue product for the treatment of seizure clusters in patients ages 2 to 5
  
• Announces immediate availability of Libervant 5mg, 7.5mg, 10mg, 12.5mg, and 15mg for patients between 2 to 5 years of age
• Company track record now includes 4 FDA approvals since 2018
• Anaphylm program on track; NDA submission expected by the end of 2024
• Hosts conference call for investors on April 29 at 8:00 a.m. ET
  

WARREN, N.J., April 29, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced the U.S. Food and Drug Administration (FDA) has approved Libervant (diazepam) Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy between 2 to 5 years of age.

“We are thrilled to have received FDA approval for Libervant in patients between the ages of two and five,” said Daniel Barber, Chief Executive Officer of Aquestive. “Patients have been waiting years for Libervant, the first and only FDA approved orally-administered rescue product for the treatment of seizure clusters. Our first priority is to provide and maintain availability of Libervant to the intended patient population. I am pleased to announce that we are currently able to accept and fill non-Medicaid prescriptions. We expect to expand our distribution capabilities over the coming weeks and months. I am also pleased with our continued track record of success with the FDA. We respect the FDA’s mission to protect public health and we will always seek to partner with the FDA wherever possible.”

“Libervant provides a new way to deliver diazepam for the treatment of acute repetitive seizure emergencies in children aged two to five,” said Michael Rogawski, M.D., Ph.D, distinguished professor of neurology and pharmacology, University of California, Davis, “The film is placed onto the buccal mucosa inside the cheek where it adheres firmly and dissolves quickly, delivering a consistent dose of diazepam. Studies show that the film is easy to administer and performs reliably in children as young as 2 years of age. Libervant is packaged in a compact foil pouch that is convenient to carry so that the treatment can be available wherever these children may be.”