RIZAPORT™ (formerly RHB-103) is a proprietary oral fast dissolving thin film formulation of rizatriptan for the treatment of migraine. RIZAPORT™ is being co-developed with Montreal-based IntelGenx Corp. following an August 2010 RedHill-IntelGenx co-development agreement. RIZAPORT™ is planned to be indicated for the treatment of acute migraines.
In March 2013, RedHill and IntelGenx submitted a New Drug Application (NDA) to the FDA seeking marketing approval of RIZAPORT™, following a positive Pre-NDA meeting with the FDA held in November 2012 and a successful bioequivalence study. The pivotal bioequivalence clinical trial demonstrated the bioequivalence between RedHill’s oral thin-film RIZAPORT™ and Merck & Co.’s Maxalt-MLT®.
In October 2014 RedHill and IntelGenx submitted a Marketing Authorization Application (MAA) to the German Federal Institute for Drugs and Medical Devices (BfArM) seeking European marketing approval of RIZAPORT™ under the European Mutual Recognition Procedure (MRP). The submission is supported by several studies, including a successful bioavailability study which established the bioequivalence of RIZAPORT™ and the European reference drug, Maxalt® lingua, and followed a a positive European Scientific Advice meeting with the German BfArM. RedHill expects to receive feedback from the BfArM regarding the marketing application during the second half of 2015.