CHAPEL HILL, N.C. In response to an approving letter from the FDA, drug developer Pozen Inc. submitted data for its new migraine drug, the company announced Monday.
Pozen and partner GlaxoSmithKline recently met with the FDA to discuss the companies’ future plan for fulfilling the agency’s appeal for the information. Pozen provided the FDA with data from three non-clinical studies for its proposed migraine medication called Trexima.
In addition to the study results submission, the company also provided the FDA with a required routine safety update and revised product labeling. The FDA may take up to six months to review this submission, although the company has requested a 60-day review.
The company also said it will launch a clinical evaluation of the Trexima’s potential of having genotoxicity, any toxic change to DNA’s structure or function.
Results of genotoxic testing will be 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 Marshall Reese, executive vice president of product development.