Research & Development
Aquestive submits Riluzole Oral Film NDA with US FDA for ALS
17 April 2019 -

Pharmaceutical company Aquestive Therapeutics Inc (NASDAQ:AQST) said on Tuesday that it has successfully filed a New Drug Application (NDA) with the US Food and Drug Administration (FDA) for the investigational product riluzole oral film (ROF) for the treatment of amyotrophic lateral sclerosis (ALS).

The company plans to market the riluzole oral film (ROF) under the brand name Exservan. It added that the goal date for the PDUFA (Prescription Drug User Fee Act) is 30 November 2019.

ROF is a novel formulation of riluzole that is used as an adjunctive therapy in the treatment of amyotrophic lateral sclerosis (ALS). The company is exploring commercial opportunities for ROF in the US and abroad and the candidate received US FDA orphan drug designation in January 2018.

Based on the company's PharmFilm technology, the development of ROF included studies demonstrating its pharmacokinetic bioequivalence to the reference listed drug, Rilutek, as well as additional studies to assess patients' ability to swallow ROF. It can be administered safely and easily, twice daily, without water, fulfilling a critical need for ALS patient.