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Trexima™ (sumatriptan/naproxen sodium) superior efficacy data published in JAMA


(NYSE: GSK;NNASDAQ: POZN) — Findings from two pivotal efficacy studies of more than 2,900 migraine sufferers demonstrated that Trexima™ provided superior headache relief at two hours and four hours compared to placebo, and two through 24-hour sustained pain-free results versus sumatriptan or naproxen monotherapy. The results were published today in the Journal of the American Medical Association (JAMA).

“Recent research suggests that migraine is more complex than previously believed, consisting of multiple mechanisms that each contribute to migraine pain in different ways,” said lead author Jan Lewis Brandes, M.D., assistant clinical professor at Vanderbilt University School of Medicine and director of the Nashville Neuroscience Group. “These studies found that Trexima, which is the first migraine-specific product designed to treat both inflammation and vasodilation in a single tablet, provided superior efficacy compared to placebo and its individual components.”

Treximais the proposed brand name for a single tablet containing sumatriptan 85 mg as the succinate salt, formulated with RT Technology™, and naproxen sodium 500 mg, for the acute treatment of migraine. These studies were the pivotal efficacy studies included in the New Drug Application currently under review by the FDA.

Trexima: Both Early and Sustained Relief

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 United States. 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 (defined as one dose of non-study medicine prescribed or recommended by a physician.) Efficacy data were reported from 2,911 patients who treated one attack each.

There were two objectives of these studies. The first was to evaluate the efficacy of Trexima at two hours post-dose versus placebo on the following variables:

Headache relief
Absence of phonophobia (sensitivity to sound)
Absence of photophobia (sensitivity to light)
Absence of nausea

The second objective was to assess the sustained effect of Trexima from two through 24 hours compared to 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-free at two hours. Trexima did reach statistical significance for sustained nausea-free two through 24 hours compared to placebo.

Significantly fewer patients on Trexima (only 22 percent in Study 1, 23 percent in Study 2) required use of rescue medication compared to sumatriptan (32 percent in Study 1, 38 percent in Study 2).

Trexima was generally well-tolerated in these studies. No serious adverse events (defined as resulting in hospitalization or death) were reported in either study for patients taking Trexima. The most common adverse effects in patients taking Trexima were dizziness (5 percent in Study 1; 3 percent in Study 2), somnolence (3 percent/4 percent), nausea (3 percent/4 percent) and paresthesia (3 percent/2 percent), dyspepsia (3 percent in Study 2 only), dry mouth (2 percent/2 percent) and chest discomfort (2 percent in Study 1 only.)


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