RedHill Biopharma and IntelGenx respond to CRL on rizatriptan

Emerging Israeli biotech firm RedHill Biopharma (TASE: RDHL), together with Canadian drug delivery specialist IntelGenx (TSXV: IGX), has submitted a response to the Complete Response Letter of the US Food and Drug Administration for the New Drug Application for RHB-103, an oral thin-film rizatriptan for the treatment of acute migraines.

The companies previously reported on February 4 that they received the FDA's CRL which raised questions primarily related to third party chemistry, manufacturing and controls (CMC) and to the packaging and labeling of the product. The FDA's CRL did not raise any questions or deficiencies relating to RHB-103's safety and did not require additional clinical studies. RedHill and IntelGenx believe that their response to the FDA addresses all the issues raised in the CRL.

RedHill and IntelGenx will continue working with the FDA on the continuing review of
the RHB-103 NDA, and will provide additional updates as and when applicable.