RedHill Migraine Trial Successful
RedHill Biopharma Ltd. (TASE: RDHL) announced positive results in a pivotal bioequivalence clinical trial with RHB-103, an oral thin-film formulation of Rizatriptan for the treatment of acute migraine. RedHill has exclusive world-wide rights and is developing RHB-103 with its Canadian co-development partner IntelGenx, Corp. (TSX: IGX ; OTCBB: IGXT). Analysis of the results demonstrates that 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 & Co.’s Maxalt-MLT, a leading, approved, migraine treatment, based on Rizatriptan, a 5-HT1 receptor agonist drug. RedHill awaits the final report of the clinical trial results, subject to which the Company and IntelGenx intend to file with the FDA a New Drug Application for a US marketing approval (NDA). The trial was conducted in Canada following discussions with the FDA and under a CTA (Clinical Trial Application) approval from Health Canada. RHB-103 is based on IntelGenx’ proprietary immediate release VersaFilm oral thin-film technology for rapid dissolution, and is targeting a significant segment of the migraine market – namely the family of triptan migraine drugs – estimated at approximately $2 billion in 2011. The world-wide sales of Merck & Co.’s Rizatriptan drugs, under their various names, including Maxalt and Maxalt-MLT – the reference drug in the RHB-103 pivotal clinical trial – exceeded $600 million in 2011.