Provision of the additional information will allow the FDA to determine the comparability of the new data to that contained within the original Trexima new drug application and to more fully assess the relative safety profile of Trexima. Trexima is indicated for the treatment of acute migraine.
“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,” stated Dr Marshall Reese, executive vice president.
Pozen expects to prepare and submit the revised response before year end.