INDICATED FOR MIGRAINE
RizaportTM is the first rizatriptan oral disintegrating film for the treatment of migraine to achieve EU marketing approval. RizaportTM is a new product opportunity co-developed in partnership with RedHill Biopharma and formulated using VersaFilm™, IntelGenx’s proprietary thin film technology. Rizatriptan is a selective 5-HT1B/1D receptor agonist indicated for the treatment of migraine. Compared to other triptan-based medications, rizatriptan demonstrates the highest efficacy and exhibits the shortest Tmax providing a quick onset of action for migraine sufferers. Rizatriptan is also indicated for the treatment of migraine attacks in children and elderly who could both benefit from the ease of administration of the film formulation. RizaportTM demonstrated bioequivalence in a successful pivotal clinical trial compared to the reference listed drug Maxalt MLT®. IntelGenx submitted a 505(b)(2) New Drug Application for regulatory approval to the U.S. Food and Drug Administration in Q1 2013. In addition, in November 2015, the German Federal Institute for Drugs and Medical Devices (BfArM) has granted national marketing approval for RizaportTM for the treatment of acute migraines under the European Decentralized Procedure (DCP). According to Merck’s annual report, sales of Maxalt® were $638 million in 2012. IntelGenx and RedHill are currently looking for a partnership or alliance opportunity to commercialize RizaportTM.