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FDA's letter accepted the bioequivalence study and safety information submitted and requires no additional clinical studies; RedHill and IntelGenx plan to address remaining issues, primarily related to third party manufacturing, packaging and labeling, within weeks, based on available data
In light of the increased regulatory clarity, RedHill and IntelGenx plan to rapidly advance ongoing discussions with potential partners for the commercialization of RHB-103
In addition to pursuing marketing approval in the U.S., RedHill and IntelGenx plan to complete the development program for the European market and submit a Marketing Authorization Application later this year
TEL-AVIV, Israel, Feb. 4, 2014 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) ("RedHill"), an Israeli biopharmaceutical company focused on the development and acquisition of late clinical-stage drugs, together with IntelGenx Corp. (TSXV:IGX) (OTCQX:IGXT) ("IntelGenx"), a Canadian drug delivery company focusing on oral drug delivery, today announced that they received a Complete Response Letter ("CRL") from the U.S. Food and Drug Administration ("FDA") regarding the New Drug Application ("NDA") for RHB-103 for the treatment of acute migraines. RHB-103 is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT
1 receptor agonist and the active drug in Merck & Co.'s Maxalt®.
A CRL is issued by the FDA's Center for Drug Evaluation and Research to inform companies that certain questions and deficiencies remain that preclude the approval of the application in its present form. The questions raised by the FDA in the CRL regarding the NDA for RHB-103 primarily relate to third party Chemistry, Manufacturing and Controls ("CMC") and to the packaging and labeling of the product. No questions or deficiencies were raised relating to the product's safety and the FDA's CRL does not require additional clinical studies.
While continuing to review the FDA's CRL, RedHill and IntelGenx believe that they can supply the requested information based on available data. IntelGenx and RedHill further believe that the majority of issues raised by the FDA were recently addressed in an amendment submitted by the companies to the FDA that has yet to be reviewed. The companies will work with the FDA to address the remaining questions in the CRL and plan to submit the requested information within a few weeks.