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FDA Grants Orphan Drug Designation to Aquestive

For their Riluzole Oral Soluble Film

By: Betsy Louda

, Contract Pharma

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Aquestive Therapeutics’ Riluzole Oral Soluble Film (riluzole OSF), for the treatment of amyotrophic lateral sclerosis (ALS). Riluzole OSF is currently in late-stage clinical development.

 

“We hope to bring riluzole OSF to ALS patients in the second half of 2019,” said Keith J. Kendall, chief executive officer of Aquestive. “Patients suffering from this debilitating neurodegenerative disease often find swallowing to be difficult or impossible. To help manage one element of this challenging disease for people with ALS and their caregivers, we developed riluzole OSF to dissolve instantly in the mouth without water, using our proprietary PharmFilm technology.”

 

The FDA’s Office of Orphan Products Development grants drug sponsors with orphan drug designation for medications that are intended for use in diseases which affect fewer than 200,000 persons in the U.S.

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