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Treximet (sumatriptan and naproxen sodium) Tablets Shown to be Effective in Patients Who Previously Had Poor Response to, or Did Not Tolerate, Migraine Treatment with a Short-Acting Triptan

BOSTON, June 27, 2008 /PRNewswire-FirstCall/ -- New data offer hope for migraine sufferers who report that they have poor response or are intolerant to their migraine therapy. Two studies of migraineurs who reported that they had poor response to, or did not tolerate, short-acting triptans, showed that treatment with Treximet provided sustained pain-free results at two through 24 hours and was generally well-tolerated. These studies were presented today at the 50th Annual Scientific Meeting of the American Headache Society in Boston.

"This information is important to people who have tried and have not yet found relief from short-acting triptans," stated Ninan Mathew, M.D., director of the Houston Headache Clinic and lead author of the study. "Patients often need to try several medications before finding a therapy that is effective. Migraine sufferers should not be discouraged if the first treatment they try doesn't provide the relief they need, but rather should speak with their doctor and re-evaluate their migraine treatment."

These data also underscore the benefits of Treximet, a prescription treatment that addresses both the early and late stages of a migraine. Treximet, the only migraine treatment designed to target multiple mechanisms of migraine by combining a triptan and an anti-inflammatory pain reliever in a single tablet, was approved by FDA in April of this year.

About the Studies

The data are from two identical randomized multi-center, double-blind, placebo-controlled crossover trials that evaluated 283 men and women who typically had a history of four to five migraines each month. Subjects in these studies had, on average, a 22 to 24-year history of migraine without aura and reported that they had discontinued treatment with a short-acting triptan due to poor response or intolerance within the past year. Subjects were randomized to receive Treximet or placebo and were instructed to treat within an hour of onset of the migraine while the headache pain was still mild.

In both studies:

-- Treximet was superior to placebo in producing sustained pain-free results from two through 24 hours (26 percent vs. 8 percent in Study 1; and 31 percent vs. 8 percent in Study 2).

-- At two hours, four in 10 subjects taking Treximet were pain-free as compared to fewer than two in 10 subjects taking placebo.

-- The majority of subjects taking Treximet were pain-free at eight hours (65 percent in Study 1; 66 percent in Study 2).

-- Fewer than three in 10 subjects taking Treximet reported the need for a rescue medication as compared to approximately six in 10 subjects taking placebo.

Each study demonstrated that, as compared to placebo, Treximet provided sustained relief at two through 24 hours of traditional migraine-associated symptoms including nausea and sensitivity to light and sound, as well as non-traditional migraine-associated symptoms including sinus and neck pain. In addition, subjects taking Treximet reported higher medication satisfaction, as compared to placebo and the triptans used prior to the study.

Treximet was generally well-tolerated: 11 percent versus 4 percent of subjects in Study 1, and 9 percent versus 5 percent of subjects in Study 2, reported any adverse event, Treximet versus placebo, respectively). One subject withdrew due to an adverse event after placebo treatment. No serious adverse events were reported. The most common drug-related adverse event (greater than or equal to 2 percent and greater than placebo) reported in these studies was chest discomfort.

This study was funded by GlaxoSmithKline.

About GlaxoSmithKline

GlaxoSmithKline -- one of the world's leading research-based pharmaceutical and healthcare companies -- is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For detailed company information, see GlaxoSmithKline's website:

Important Safety Information About Treximet

Prescription Treximet is indicated for the acute treatment of migraine attacks, with or without aura, in adults. Treximet should only be used where a clear diagnosis of migraine headache has been established.

Treximet may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Treximet contains a non-steroidal anti-inflammatory drug (NSAID). NSAID-containing products cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.

Treximet is contraindicated in patients with history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes and in patients with other significant underlying cardiovascular diseases. Treximet should not be given to patients in whom unrecognized coronary artery disease is predicted by the presence of risk factors without a prior cardiovascular evaluation. Treximet should not be given to patients with uncontrolled hypertension because the components have been shown to increase blood pressure.

Concurrent administration of MAO-A inhibitors or use of Treximet within two weeks of discontinuation of MAO-A inhibitor therapy is contraindicated. Treximet and any ergotamine-containing or ergot-type medication (like dihydroergotamine and methysergide) should not be used within 24 hours of each other. Since Treximet contains sumatriptan, it should not be administered with another 5-HT1 agonist.

Treximet is contraindicated in patients with hepatic impairment. Treximet is contraindicated in patients who have had allergic reactions to products containing naproxen. It is also contraindicated in patients in whom aspirin or other NSAIDs/analgesic drugs induce the syndrome of asthma, rhinitis, and nasal polyps. Both types of reactions have the potential of being fatal. Treximet is contraindicated in patients with hypersensitivity to sumatriptan, naproxen, or any other component of the product.

Cerebrovascular events have been reported in patients treated with sumatriptan. In a number of cases, it appears possible that the cerebrovascular events were primary. It is important to advise patients not to administer Treximet if a headache being experienced is atypical.

The development of a potentially life-threatening serotonin syndrome may occur with triptans, including treatment with Treximet, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or selective norepinephrine reuptake inhibitors (SNRIs).

NSAID-containing products, including Treximet, should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding.

Treximet should not be used in late pregnancy because NSAID-containing products have been shown to cause premature closure of the ductus arteriosus. Treximet should not be used during early pregnancy unless the potential benefit justifies the potential risk to the fetus.

For complete Prescribing Information for Treximet please visit

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Posted: June 2008