Regulators in the US have accepted Aquestive Therapeutics’ New Drug Application (NDA) for the investigation product riluzole oral film (ROF).
ROF – which the company intends to market under the brand name Exservan – is a novel formulation of riluzole, which is used as an adjunctive therapy in the treatment of amyotrophic lateral sclerosis (ALS).
“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.”
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 fulfil 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.