Trexima Working on Approval

Pozen, in partnership with GlaxoSmithKline, is still working on FDA approval for its new migraine drug called Trexima. Previously the FDA had concerns about the potential cardiovascular side effects of the drug. However, Pozen is now doing extra testing to provide the FDA with data on the geneotoxic potential of their product. While they feel there is no problem with the drug, they want to have the information ready just in case the FDA requests it.

Pozen has asked for a 60-day review. Their product is a combination of the popular migraine medicine Imitrex and naproxen. Naproxen is a non-steroid anti-inflammatory drug. The benefits of these drugs in one pill are that it will address the problems of blood vessel dilation as well as inflamation around the blood vessels. If approved, Trexima could help many the 28 million people in the United States who suffer from migraine pain.