FDA's "approvable" letter for Pozen's migraine treatment Trexima (sumatriptan/naproxen) relates to safety questions, the firm announced June 9.

The agency wants additional safety information on the drug, which may require new studies, according to Pozen and development partner GlaxoSmithKline. However, FDA is satisfied with efficacy, the companies said.

Pozen submitted the NDA on August 8, 2005 and received a standard review.

Pozen and GSK had planned to launch the drug in the third quarter. GSK told "The Pink Sheet" DAILY that it was unsure whether a delay would now occur. The companies plan to meet with FDA to discuss the letter and next steps for the application.

Under a June 2003 deal with GSK, Pozen is slated to receive a $10 mil. milestone payment if the NDA is approved and an additional $10 mil. upon commercial launch.

The approvable letter is the latest headache for Pozen, which discontinued development of another migraine treatment, MT 100 (naproxen/metococlopramide), last August following a negative advisory committee review (¹ Also see "Trexima NDA Filing Relieves Pozen’s MT 100 Headache" - Pink Sheet, 8 August, 2005.).

Trexima is a fast-acting co-formulation of sumatriptan (GSK's Imitrex ) that the company says interacts with naproxen to extend absorption. It is the first product designed to treat multiple mechanisms of migraine, inflammation and vasodilation, according to the firms.

GSK may have wanted to launch in the third quarter ahead of upcoming patent expirations on Imitrex. According to FDA's Orange Book, one patent expires on Dec. 28, 2006 and another on June 28, 2007.

-Jonathan Block

Trexima Approvable Letter Another Headache For Pozen

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