Aquestive Therapeutics receives FDA ODE for Libervant Buccal Film

Aquestive Therapeutics (AQST) announced the U.S. Food and Drug Administration, FDA, has granted seven years of orphan drug exclusivity, ODE, to Libervant Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern in patients with epilepsy between two to five years of age. On April 26, 2024, Libervant Buccal Film was approved for pediatric patients between two to five years of age. FDA granted ODE based on their assessment that Libervant’s buccal route of administration provides a major contribution to patient care over the rectal route of administration by providing a significantly improved ease of use.