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Orally dissolving film formulation of riluzole is now available for patients who have difficulty swallowing.
PANTHERx Rare has been selected by Mitsubishi Tanabe Pharma America (MTPA) as the U.S. pharmacy distribution partner for Exservan (riluzole). PANTHERx, part of Envolve Pharmacy Solutions, is a rare disease pharmacy located in Pittsburgh, Pa.
The drug, an oral film formulation of riluzole, was approved by the FDA in November 2019 for the treatment of amyotrophic lateral sclerosis (ALS). The approval was based on a pivotal bioavailability and bioequivalence study to bridge the safety and efficacy of the new oral film formulation to the approved tablet dosage form of riluzole. Exservan was shown to deliver a similar amount of medication throughout the bloodstream as the riluzole tablets.
“People with ALS can develop difficulty swallowing, affecting how certain medications are administered,” Atsushi Fujimoto, president, MTPA, said in a statement.
Exservan was developed by Aquestive Therapeutics using its PharmFilm drug delivery technology. Under the terms of a licensing and supply deal agreement, MTPA is commercializing the therapy in the United States and Aquestive is serving as the exclusive sole manufacturer and supplier for the product.
ALS affects as many as 30,000 people in the United States, with 5,000 new cases diagnosed each year. As the disease progresses, patients can have difficulty swallowing.