RedHill Biopharma Ltd. and IntelGenx Corp. have received a Complete Response Letter (CRL) from the FDA regarding the NDA for RHB-103 for the treatment of acute migraines. RHB-103 is an oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck’s Maxalt. The questions raised in the CRL for RHB-103 primarily relate to third party Chemistry, Manufacturing and Controls (CMC) and to the packaging and labeling of the product. There were no questions or deficiencies relating to the product's safety and the FDA’s CRL does not require additional clinical studies.
The companies believe that they can supply the requested information based on available data and that the majority of issues raised by the FDA were recently addressed in an amendment submitted by the companies for review. The companies will work with the FDA to address the remaining questions in the CRL in pursuit of marketing approval in the U.S. RedHill and IntelGenx are in the process of selecting potential partners for the commercialization of RHB-103.
"We appreciate the thorough review of the RHB-103 NDA by the FDA. We remain committed to bringing RHB-103 to market as quickly as possible and will work closely with the FDA to advance the application and address all questions raised by the FDA," said Rajiv Khosla, IntelGenx' president and chief executive officer and Dror Ben-Asher, RedHill's chief executive officer in a joint statement. "We believe that the questions raised by the FDA can be addressed based on available data, and we plan to work vigorously to submit our response within a few weeks in order to bring this product to market as a new therapeutic option for the benefit of patients suffering from migraines."