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Aquestive Therapeutics Announces U.S. Food and Drug Administration (FDA) Acceptance of New Drug Application for Riluzole Oral Film for Treatment of ALS

2.5 from 4 votes
Thursday, April 18, 2019

WARREN, N.J. - Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products to solve therapeutic problems, announced that 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.

"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.

About Aquestive Therapeutics
Aquestive Therapeutics is a specialty pharmaceutical company that applies innovative technology to solve therapeutic problems and improve medicines for patients. Aquestive is advancing a late-stage proprietary product pipeline to treat CNS conditions and provide alternatives to invasively-administered standard of care therapies. The company also collaborates with pharmaceutical partners to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm, and has proven capabilities for drug development and commercialization.

Christopher Hippolyte

Stephanie Carrington

Source: Aquestive Therapeutics
2.5 from 4 votes
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