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 migraine.
The RHB-103 NDA is currently under substantive review by the FDA, with a PDUFA goal date of February 3, 2014.
In November 2013, RedHill announced is had concluded a positive European Scientific Advice meeting with the German Federal Institute for Drugs and Medical Devices (BfArM).
Following the positive meeting with the BfArM, RedHill plans to complete a bioavailability study and submit a Marketing Authorization Application (MAA) for marketing approval of RHB-103 in Europe, with Germany as the reference member state under the European Mutual Recognition Procedure (MRP), during the first half of 2014.
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® with 2012 world-wide annual sales exceeding $600 million in its various formulations..