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news.RedHill Biopharma has announced positive results from a pivotal bioequivalence trial with RHB-103, an oral thin-film formulation of Rizatriptan for the treatment of acute migraine.
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The trial met its specified endpoints and FDA’s criteria, in all parameters for bioequivalence, between RedHill’s RHB-103 oral thin-film, and Merck’s Maxalt-MLT.
RedHill RHB-103 Product Manager Elkan Gamzu said, "The positive clinical trial results, coupled with RHB-103’s unique delivery – a rapidly dissolving oral thin-film – may prove to be a significant competitive advantage in the large market for migraine treatments, estimated in billions."
RedHill has exclusive world-wide rights and is developing RHB-103 with its co-development partner IntelGenx, in Canada.
The company and IntelGenx intend to file a new drug application with the FDA for a US marketing approval, once the final report of the trial gets ready.