Aquestive Therapeutics announced the U.S. Food and Drug Administration (FDA) has accepted the Company's New Drug Application (NDA) for the investigational product riluzole oral film (ROF), which the Company intends to market under the brand name Exservan™. ROF is a novel formulation of riluzole, which is used as an adjunctive therapy in the treatment of amyotrophic lateral sclerosis (ALS). The PDUFA (Prescription Drug User Fee Act) goal date is November 30, 2019. The Company is exploring commercial opportunities for ROF in the U.S. and abroad.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox! Sign up now!
"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 U.S. and globally," said Daniel Barber, Chief Strategy and Development Officer of Aquestive. "Oral films offer great promise to patients who face difficulty swallowing or administering traditional forms of medication. In addition to Exservan, we are also focused on advancing Libervant toward an NDA filing this year. We believe these innovations are important and can help patients interact consistently and compliantly with their medication."
The development of ROF with PharmFilm® technology included studies demonstrating the product's pharmacokinetic bioequivalence to the reference listed drug, Rilutek®, as well as additional studies to assess patients' ability to swallow ROF. Aquestive believes that ROF can fulfill a critical need for ALS patients, given it can be administered safely and easily, twice daily, without water.
Riluzole oral film received FDA orphan drug designation in January 2018.