RHB-103 is a proprietary oral fast dissolving thin film formulation of rizatriptan for the treatment of migraine. RHB-103 is being co-developed with Montreal-based IntelGenx Corp. following an August 2010 RedHill-IntelGenx co-development agreement. RHB-103 is planned to be indicated for the treatment of acute migraines.
In May 2012, RedHill announced positive results in a pivotal bioequivalence clinical trial demonstrating bioequivalence between RedHill’s oral thin-film RHB-103 and Merck & Co.’s Maxalt-MLT®.
In November 2013, RedHill announced it had concluded a positive European Scientific Advice meeting with the German Federal Institute for Drugs and Medical Devices (BfArM). Following the meeting with the BfArM, RedHill conducted a successful bioavailability study, which established the bioequivalence of RHB-103 and the European reference drug, Maxalt® lingua.
RedHill plans to submit a Marketing Authorization Application (MAA) for marketing approval of RHB-103 in Europe during the third quarter of 2014, with Germany as the reference member state under the European Mutual Recognition Procedure (MRP).