FDA approves Exservan oral film, for the treatment of amyotrophic lateral sclerosis.- Aquestive Therapoeutics

Aquestive Therapeutics, Inc. announced that Exservan (riluzole) Oral Film received early-action approval from the FDA, in advance of our PDUFA action date, for the treatment of amyotrophic lateral sclerosis (ALS), an orphan disease. Exservan (riluzole) Oral Film is now approved for the treatment of ALS, a debilitating and rare disease affecting as many as 30,000 Americans and 52,000 Europeans. Exservan will now fill a critical need in the armamentarium for ALS patients because it can be administered safely and easily, twice daily, without water where many patients have trouble swallowing.

Development initiatives conducted by Aquestive have included studies demonstrating Exservan's pharmacokinetic bioequivalence to the reference listed drug, Rilutek, as well as additional studies to assess patients' ability to swallow Exservan. Exservan received FDA orphan drug designation in January 2018.