FDA Accepts NDA for Riluzole Oral Film for ALS Treatment

The US Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for riluzole oral film, an investigational treatment, for the treatment of amyotrophic lateral sclerosis (ALS), which is also known as Lou Gehrig's Disease.

The FDA’s decision on whether to approve or not is expected by the Prescription Drug User Fee Act (PDUFA) date of November 30, 2019.

Aquestive Therapeutics, Inc., which submitted the NDA, intends to market riluzole oral film under the brand name Exservan.

"We're pleased the FDA has accepted our NDA for Exservan, given the needs ALS patients have for treatment advances. ALS, though relatively rare, represents a considerable economic and social burden in the US and globally," said Daniel Barber, Chief Strategy and Development Officer of Aquestive. He shared his belief that the oral film option “can help patients interact consistently and compliantly with their medication."

Riluzole oral film was granted FDA orphan drug designation in January 2018. The film formulation was developed using PharmFilm technology and is intended as an easier option for the many patients with ALS who develop dysphagia and cannot swallow easily. Riluzole oral film can be administered twice daily without the need for water or swallowing.

"Oral films offer great promise to patients who face difficulty swallowing or administering traditional forms of medication,” added Barber.

Riluzole has been offered in an oral suspension form (Tiglutik), approved by the FDA in September 2018, that was also intended for patients with ALS who have difficulty swallowing.

Riluzole in tablet form (Rilutek) was approved by the FDA in 1995 for the treatment of ALS. Riluzole oral film has been studied and demonstrated bioequivalence to the tablet form, according to Aquestive Therapeutics.