Pozen has submitted additional data to the Food and Drug Administration in its continuing efforts to win approval for the proposed migraine drug Trexima.
The company also plans an additional clinical trial to gather data about the genotoxic potential of Trexima “in the event the FDA requires this data,” Pozen said in a statement.
Genotoxic refers to chemicals that can damage DNA.
Pozen (Nasdaq: ) and GlaxoSmithKline, its partner in development of Trexima, recently met with the FDA to discuss additional information after the FDA rejected Trexima on August 1.
While the FDA could take up to six months to evaluate the additional information, Pozen said it has requested a 60-day review.
Newly submitted information covers a safety update, revised product labeling and additional lab test results.
“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 product development at Pozen, in a statement.
In an earlier review of the drug the FDA expressed concern about cardiovascular side effects.
Pozen used its proprietary technology to combine an existing GSK migraine drug Imitrex with naproxen, a non-sterodial anti-inflammatory drug.
According to the American Medical Association, migraines affect an estimated 28 million people.
GSK has paid Pozen more than $35 million to develop Trexima.