The submission includes, in addition to a required routine safety update and revised product labeling, the results of three non-clinical (in vitro) studies that provide clarifying information about a previously submitted non-clinical study, the Chinese hamster ovary assay. Although the company has requested a 60-day review, the FDA may take up to six months to make a decision, Pozen said.
Pozen plans to conduct a clinical evaluation of the genotoxic potential of Trexima in a short-term study in human volunteers in the event the FDA requires this data. This study is expected to begin this quarter with results available for submission to and review by the FDA, if required, during the first quarter of 2008.
“Although we believe that our submission addresses FDA’s concern regarding the genotoxic potential of Trexima, we feel it is prudent to conduct this clinical trial so that we can provide this information without delay, if required,” said Dr Marshall Reese, executive vice president, product development.
The submission is Pozen and GSK’s second response to an approvable letter from the FDA. The first letter, in January, required additional data regarding the cardiovascular safety of Trexima, while the second, in August, asked the companies to address the agency’s concern about a study which appeared to demonstrate genotoxicity for the combination of naproxen sodium and sumatriptan.
Trexima combines GSK’s migraine drug Imitrex (sumatriptan succinate) with NSAID naproxen sodium, and was developed to treat both inflammation and vasodilation in a single tablet in order to provide sustained pain relief for migraine sufferers.