IntelGenx announced in partnership with RedHill Biopharma announced they resubmitted the 505(b)(2) NDA to the FDA for RIZAPORT 10 mg.
IntelGenx (TSXV:IGX; OTCQX:IGXT) announced in partnership with RedHill Biopharma (NASDAQ:RDHL) announced they resubmitted the 505(b)(2) New Drug Application (NDA) to the US Food and Drug Administration (FDA) for RIZAPORT 10 mg.
As quoted in the press release:
RIZAPORT is a proprietary oral thin-film formulation of rizatriptan for the treatment of acute migraines. RIZAPORT offers an innovative and potentially advantageous 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 flavor.
Following a first RIZAPORT NDA submission to the FDA in March 2013, IntelGenx and RedHill received a Complete Response Letter (“CRL”) from the Agency. The questions raised by the FDA, which triggered the current resubmission, primarily related to third party chemistry, manufacturing and controls, and the packaging and labeling of the product. The FDA raised no questions or deficiencies relating to RIZAPORT’s safety and bio-equivalence data and did not require additional clinical trials.