FDA decision on Trexima may trigger new studies

The FDA has issued an approvable letter to POZEN and GlaxoSmithKline for Trexima as an acute therapy for migraines. But the drug developer says the agency's request for more safety data may require more studies of the drug. Researchers are seeking a meeting with the FDA to clarify their request. Trexima is a combination of sumatriptan 85 mg, as the succinate salt, formulated with RT Technology and naproxen sodium 500 mg in a single tablet. It is the first product designed to treat multiple mechanisms of migraine: inflammation and vasodilation.

- here's the release on Trexima