FDA Clears Oral Film Formulation of ALS Drug Riluzole (Exservan)

Megan Brooks


November 25, 2019

The US Food and Drug Administration (FDA) has approved an oral film formulation of riluzole (Exservan, Aquestive Therapeutics) for the treatment of patients with amyotrophic lateral sclerosis (ALS), the company has announced.

Exservan oral film fills 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," the company said in a news release.

Studies conducted by the company demonstrate the product's pharmacokinetic bioequivalence to the reference listed drug Rilutek.

Exservan received FDA orphan drug designation in January 2018. The FDA approved the new drug application for the product ahead of the Prescription Drug User Fee Act action date.

Last year, the FDA approved a liquid form of riluzole (Tiglutik, ITF Pharma), which is administered via oral syringe for patients with ALS.

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