Aquestive Therapeutics, Inc. 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. In 2023, over 55,000 prescriptions were filled for patients between the ages of 2 and 5. This was an increase of 10.8% over the previous year and an average increase of 9.3% over the last three years for this patient population.

Over 90% of filled prescriptions in 2023 for this patient population were for diazepam rectal gel. Prescription writing for this indication is highly concentrated among pediatric epileptologists and pediatric neurologists. The Company?s Anaphylm?

(epinephrine) Sublingual Film clinical development program remains on track. The Company is currently in the clinic completing the remaining studies required for the submission of the New Drug Application (NDA) for Anaphylm, which is planned for the end of 2024. The Company will provide a more detailed update on Anaphylm at its upcoming first quarter 2024 earnings call on May 8, 2024.