RedHill Biopharma receives complete response letter from FDA for acute migraines drug

RHB-103 is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1 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.

RedHill and IntelGenx have been in active discussions with potential partners for the commercialization of RHB-103 and expect to advance these discussions rapidly following FDA’s CRL which provides increased regulatory clarity, indicates that no further clinical trials are required, and raises no issues regarding RHB-103’s safety.

In addition to pursuing marketing approval in the US, and following a positive meeting with the German pharmaceuticals regulation authority "BfArM" in October 2013, RedHill and IntelGenx plan to complete the development program for the European market and submit a marketing authorization application for marketing approval of RHB-103 in Europe later this year, with Germany as the reference member state under the European Mutual Recognition Procedure.

RHB-103 is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck & Co.’s Maxalt.

Rizatriptan is considered one of the most effective oral triptans, a class of molecules that constrict blood vessels in the brain to relieve swelling and other migraine symptoms.

RHB-103 is based on IntelGenx’ proprietary VersaFilm technology. It dissolves rapidly in the mouth, leading to the absorption of the drug through the gastro intestinal track and into the bloodstream.

The administration method of the RHB-103 oral thin film does not require the patient to swallow a pill or consume water, and presents a potentially attractive therapeutic alternative for many migraine patients, including those who suffer from migraine-related nausea.