FDA delays decision on Pozen/GSK's Trexima

North Carolina, USA-based drugmaker Pozen and UK pharmaceutical giant GlaxoSmithKline say that the US Food and Drug Administration has issued an approvable letter for its migraine pill Trexima (sumatriptan and naproxen sodium). The approvable letter is the FDA's official notification that contains conditions that must be satisfied before final clearance to market a drug in the USA.

According to the firms, the agency has determined that Trexima is effective as an acute treatment for migraine headaches but has requested additional safety information on the drug, which may require new studies. Pozen and GSK intend to request a meeting with the FDA as quickly as possible to discuss the approvable letter and determine the next steps. A likely approval date can only be known once it is clear what action the agency wants the firms to take.

Trexima, the proposed brand name for the product candidate combining sumatriptan 85mg, as the succinate salt, formulated with RT Technology and naproxen 500mg in a single tablet, is the first product designed to treat multiple mechanisms of migraine - inflammation and vasodilation.