FDA REQUESTS MORE DATA ON POZEN'S MIGRAINE DRUG

Pozen announced that the FDA has completed its initial review of the company's response to the approvable letter for Trexima sent in June, and the agency and has determined the response not yet complete. The FDA has requested additional analyses and supporting information relating to the data submitted in the November response.

Provision of the additional information will allow the FDA to determine the comparability of the new data submitted in November to that contained within the original Trexima new drug application (NDA) and to more fully assess the relative safety profile of Trexima, according to the company. Pozen expects to prepare and submit the revised response before the end of the year.

"We appreciate this additional guidance from the FDA with respect to the information to be included in our complete response. Although there is no certainty that these revisions, coupled with the original data, will lead to the approval of the Trexima NDA, we continue to believe that the data for Trexima demonstrate superior efficacy and a safety profile comparable to sumatriptan," Marshall Reese, executive vice president of product development at Pozen, said.

Trexima, a combination of sumatriptan and naproxen sodium in a single tablet, is designed to address two major causes of migraine: blood vessel dilation and the inflammation around the blood vessels and nerves, according to the company.