BRIEF—RedHill Biopharma and IntelGenx file for Rizaport approval

Israeli biotech firm RedHill Biopharma together with IntelGenx, a Canadian oral drug delivery company, today announced that they have resubmitted the 505(b)(2) New Drug Application (NDA) for Rizaport 10mg to the US Food and Drug Administration.

Rizaport is a proprietary oral thin film formulation of rizatriptan for the treatment of acute migraines.

Following a first NDA submission to the FDA in March 2013, RedHill and IntelGenx received a Complete Response Letter (CRL) from the FDA.

The questions raised by the FDA, which triggered the current resubmission, primarily related to third party chemistry, manufacturing and controls (CMC) and to the packaging and labeling of the product.

The FDA letter raised no questions or deficiencies relating to Rizaport’s safety and bio-equivalence data and did not require additional clinical trials.

If the Rizaport NDA resubmission is deemed complete and permits a full review by the FDA, a Prescription Drug User Fee Act (PDUFA) date is expected to be set by the FDA for the first half of 2018.