The Food and Drug Administration (FDA) has approved Exservan (riluzole oral film; Aquestive Therapeutics) for the treatment of amyotrophic lateral sclerosis (ALS).

The approval was based on pharmacokinetic studies demonstrating bioequivalence of Exservan oral film to oral riluzole tablets. The mechanism by which riluzole exerts its therapeutic effects in ALS patients is unknown, however clinical studies have shown that it modulates glutamate neurotransmission by inhibiting both glutamate release and postsynaptic glutamate receptor signaling.

“We anticipate that Exservan, via our orally administered PharmFilm dosage form, will bring meaningful treatment to patients who are diagnosed with ALS and face difficulties swallowing or administering traditional forms of medication,” said Keith J. Kendall, Chief Executive Officer of Aquestive.

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Each oral film contains 50mg of riluzole and is packaged in individual pouches, with 60 pouches per carton. The oral film is applied on top of the tongue where it adheres and dissolves.

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