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 will be indicated for the treatment of migraine.
In March 2013, RedHill and IntelGenx submitted a New Drug Application (NDA) to the FDA seeking marketing approval of RHB-103, following a positive Pre-NDA meeting with the FDA held in November 2012.
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.