The U.S. Food and Drug Administration has “accepted for review” the latest information drug developer Pozen filed on behalf of its proposed migraine drug, Pozen said Thursday.
A decision by the FDA whether to approve Trexima could be made within six months, Pozen said in a brief statement.
Pozen and its partner GlaxoSmithKline have been fighting to win approval of Trexima for nearly two years. Pozen submitted additional information to the FDA last month after the latest in a series of FDA setbacks in August.
“The FDA has also notified Pozen that it considers the submission to be a complete, Class II response (six months) which could result in a new decision date of April 15, 2008,” the company said.
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.