Pharmaceuticals / Regulatory Affairs / GMPs

RedHill, IntelGenx Get Complete Response Letter for Migraine Drug


Israeli-owned RedHill Biopharma and Canada’s IntelGenx have received a complete response letter from the FDA for their RHB-103 migraine drug, which cites problems with the pharma partners’ third-party chemistry, manufacturing and controls, packaging and labeling issues. The letter did not raise any concerns about the safety and effectiveness of RHB-103 and no further clinical trials will be required, the drugmakers said.

“We plan to work vigorously to submit our response within a few weeks in order to bring this product to market,” RedHill CEO Dror Ben-Asher and IntelGenx CEO Rajiv Khosla said in a joint statement. Both companies believe that the FDA’s observations can be addressed in an amendment already submitted but yet to be reviewed.

RHB-103 is a thin oral film consisting of rizatriptan benzoate that is one of a class of drugs that constrict blood vessels in the brain to relieve swelling and other symptoms of migraines. The drugmakers are planning to submit an EU marketing authorization application later this year.

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