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# Aquestive Therapeutics Orphan Designation for ALS Drug
- URL: https://www.fdaweb.com/aquestive-therapeutics-orphan-designation-for-als-drug/
- Published: 2018-01-31T12:00:00.000Z
- Updated: 2026-09-14T23:18:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140649

FDA has granted Aquestive Therapeutics an orphan drug designation for riluzole oral soluble film (OSF) for treating amyotrophic lateral sclerosis (ALS), which affects about 30,000 Americans. Riluzole OSF is currently in late-stage clinical development. Patients suffering from ALS often have difficulty swallowing. Riluzole film was developed to dissolve instantly in the mouth without water, using the company’s proprietary PharmFilm technology.