RedHill Biopharma and IntelGenx submit NDA to FDA for Rizaport for migraines

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

Rizaport - a proprietary oral thin-film formulation of rizatriptan for the treatment of acute migraines - offers an innovative therapeutic alternative for many migraine patients, primarily patients who suffer from dysphagia or migraine-related nausea, due to its convenient dosing, facile intake due to the lack of need for water, and neutral flavour.

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 Riza[prtNDA 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.

Reza Fathi, PhD, RedHill’s Senior VP Research & Development, said: “We are very pleased with the resubmission of the US NDA for Rizaport, which follows the marketing authorization received for Rizaport in Germany and Luxembourg under the European Decentralized Procedure. Our efforts are focused on commercializing Rizaport through partners in the US, Europe and other territories in the near future, and we are continuing the dialogue with potential partners.”

“This resubmission of the Rizaport 505(b)(2) NDA is an important milestone for IntelGenx,” commented Dr Horst G. Zerbe, President and CEO of IntelGenx. “We look forward to continuing to work with the FDA as we seek to bring this product to market as a new therapeutic option for the benefit of patients suffering from migraines."