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FDA Approves Combination Sumatriptan/Naproxen Sodium for Acute Treatment of Migraine

NEW YORK -- April 17, 2008 -- The US Food and Drug Administration (FDA) has approved a combination pill, sumatriptan/naproxen sodium (Treximet) for the acute treatment of migraine attacks with or without aura in adults. This is the first and only migraine treatment that combines 2 therapies in 1 tablet -- a triptan and an anti-inflammatory pain reliever -- thereby targeting multiple mechanisms of migraine. The combination pill contains sumatriptan 85 mg and naproxen sodium 500 mg.

In clinical trials, a significantly greater percentage of patients achieved migraine pain relief at 2 hours with the sumatriptan/naproxen combination compared with sumatriptan 85 mg or naproxen sodium 500 mg alone. In addition, the combination pill provided more patients with sustained migraine pain relief from 2 to 24 hours compared with the individual components.

"Migraine patients want their medicine to work early and to continue to provide relief," said Stephen Silberstein, MD, Professor of Neurology and Director, Jefferson Headache Center, Thomas Jefferson University, Philadelphia, Pennsylvania, and an investigator who participated in clinical trials. "The FDA approval of [sumatriptan/naproxen] is good news for migraine patients, because clinical trials showed that [the combination pill] produced sustained migraine pain relief for a significant number of patients." Furthermore, Dr. Silberstein said that significantly fewer patients on sumatriptan/naproxen required the use of a rescue medication to treat their migraine attack compared with those taking sumatriptan 85 mg alone.

The approval of sumatriptan/naproxen was based on data from 2 identical double-blind, randomised, placebo-controlled, parallel-group, multicentre studies of more than 2,900 migraine sufferers. Findings from these studies demonstrated that the combination tablet provided more patients with migraine pain relief at 2 and 4 hours compared with sumatriptan 85 mg, naproxen sodium 500 mg, or placebo alone. In these studies, sumatriptan/naproxen was effective at relieving the pain of a migraine attack and maintaining that relief from 2 to 24 hours. In addition, sumatriptan/naproxen effectively relieved migraine-associated symptoms -- nausea and sensitivity to light and sound -- compared with placebo.

The most common treatment-related adverse events reported within 24 hours of taking sumatriptan/naproxen were dizziness; nausea; somnolence; chest discomfort and chest pain; neck, throat, and jaw pain, tightness, and pressure; numbness/tingling; upset stomach; and dry mouth.

Sumatriptan/naproxen was also studied in a 1-year, open-label tolerability and safety study of 565 patients who treated nearly 24,500 migraine attacks with the active drug. Patients completing the 1-year study treated an average of 5 migraine attacks per month with the combination tablet.

The combination sumatriptan/naproxen tablets are expected to be available in US pharmacies by mid-May.

SOURCE: GlaxoSmithKline and POZEN Inc.

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