Pozen's Trexima Performs Better Than Other Migraine Drugs in Published Studies

Findings from two pivotal efficacy studies of more than 2,900 migraine sufferers demonstrated that Pozen's Trexima provided superior headache relief at two and four hours compared with placebo. The results were published in The Journal of the American Medical Association.

Trexima is the proposed brand name for a single tablet containing sumatriptan 85 mg, formulated with RT Technology, and naproxen sodium 500 mg for the acute treatment of migraine. These trials were the pivotal efficacy studies included in the company's new drug application, which was submitted in 2005.

To help evaluate the efficacy and safety of Trexima, two randomized, double-blind, parallel-group, placebo-controlled, single-attack studies were conducted in 118 sites in the U.S. A total of 3,413 patients were randomized to receive a single Trexima tablet, a single tablet containing sumatriptan 85 mg formulated with RT Technology, a single tablet containing naproxen sodium 500 mg or placebo. If patients did not achieve headache relief within two hours, they were permitted to use rescue medication.

There were two objectives of these studies. The first was to evaluate the effects of Trexima versus placebo at two hours post-dose on: headache relief, absence of phonophobia, absence of photophobia and absence of nausea. The second objective was to assess the sustained effect of Trexima from two to 24 hours compared with sumatriptan or naproxen sodium alone.

In Study 1, Trexima demonstrated superiority for all primary endpoints. In Study 2, Trexima demonstrated superiority for the primary endpoints, with the exception of the incidence of nausea at two hours. Trexima did reach statistical significance for sustained nausea relief at two to 24 hours compared with placebo. Trexima was generally well tolerated.