GlaxoSmithKline, Pozen say one tablet combats vascular, neurological causes of migraine

By Elaine Rigoli

Tampa, Fla., April 5 - A single tablet containing sumatriptan 85 mg as the succinate salt, formulated with RT Technology, and naproxen sodium 500 mg showed superior results in treating acute migraine pain compared to sumatriptan alone or a placebo, GlaxoSmithKline and Pozen announced.

Findings from two identical studies including more than 2,800 migraine sufferers showed more patients in the sumatriptan/naproxen sodium arm reported pain relief at two hours and four hours, compared to sumatriptan alone or a placebo, according to a news release.

Significantly more patients taking the single tablet were satisfied/very satisfied than compared to those taking a placebo, sumatriptan formulated with RT Technology or naproxen sodium alone, the release said.

Further, patients taking the single tablet had a significant reduction in mean total lost workplace productivity versus a placebo.

A one-year study of 565 patients who treated nearly 24,500 migraine attacks (an average of five attacks per month) with the single tablet reported no new or unexpected adverse events.

This single tablet is under review with the Food and Drug Administration under the proposed brand name Trexima (sumatriptan succinate/naproxen sodium).

Recent data suggest that the pathophysiology of migraine is complex and that migraine is not merely a vascular problem, but a result of a chain of events that are both vascular and neurological, the release said.

The new data was presented Wednesday at the annual meeting of the American Academy of Neurology in San Diego.

GlaxoSmithKline is a London-based pharmaceutical and health care company.

Based in Chapel Hill, N.C., Pozen focuses on the development of pharmaceutical products for the treatment of acute and chronic pain, migraine or other pain-related conditions.

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