Press release: Treximet(TM) (Sumatriptan and Naproxen Sodium) Tablets Approved by FDA for Acute Treatment of Migraine

    Clinical studies show Treximet provided significantly more patients
             migraine pain relief compared to sumatriptan 85 mg

    LONDON, April 15 /PRNewswire-FirstCall/ — GlaxoSmithKline and POZEN Inc.) announced today that the FDA has approved Treximet for the acute treatment of migraine attacks with or without aura in adults. Treximet is the first and only migraine product designed to target multiple mechanisms of migraine by combining a triptan, a class of migraine-specific medicines pioneered by GSK, and an anti-inflammatory pain reliever in a single tablet.

    Treximet contains 85 mg sumatriptan, formulated with RT Technology(TM), and 500 mg naproxen sodium. Sumatriptan is the active ingredient in Imitrex(R) Tablets, available in 25 mg, 50 mg and 100 mg strengths. In clinical trials, Treximet provided a significantly greater percentage of patients migraine pain relief at two hours compared to sumatriptan 85 mg or naproxen sodium 500 mg alone. In addition, Treximet provided more patients sustained migraine pain relief from two to 24 hours compared to the individual components.

    “Migraine patients want their medicine to work early, and to continue to provide relief,” said Dr. Stephen Silberstein, professor of neurology and director of the Jefferson Headache Center at Thomas Jefferson University and an investigator who participated in clinical trials. “The FDA approval of Treximet is good news for migraine patients because clinical trials showed that Treximet produced sustained migraine pain relief for a significant number of patients.” Further, Silberstein said,  significantly fewer patients on Treximet required the use of a rescue medication to treat their migraine attack than those taking sumatriptan 85 mg.

    Treximet is well studied, with more than 3,700 migraine sufferers treating nearly 30,000 migraine attacks in clinical studies. The product is expected to be available in U.S. pharmacies by mid-May.

    Clinical Trials Demonstrated Superior Efficacy to Individual Components

    The approval of Treximet was based on data from two identical double-blind, randomized, placebo-controlled, parallel-group, multicenter studies of more than 2,900 migraine sufferers.

    Findings from these pivotal studies demonstrated that Treximet provided more patients migraine pain relief at two and four hours compared to sumatriptan 85 mg, naproxen sodium 500 mg or placebo alone. Importantly, in these studies Treximet was effective at relieving the pain of a migraine attack and maintaining that relief from two to 24 hours. In addition, Treximet effectively relieved migraine associated symptoms — nausea and sensitivity to light and sound — compared to placebo.

    Treximet was generally well-tolerated in these pivotal studies. The most common treatment-related adverse events reported within 24 hours of taking Treximet were dizziness; nausea; somnolence; chest discomfort and chest pain; neck, throat and jaw pain, tightness and pressure; numbness/tingling; upset stomach; and dry mouth.

    Treximet was also studied in a one-year open-label tolerability and safety study of 565 patients who treated nearly 24,500 migraine attacks with the active drug. Patients completing the one-year study treated an average of five migraine attacks per month with Treximet.

    Migraines Impact Millions of Americans

    Migraine headaches continue to be a significant problem for the estimated 29.5 million Americans, nearly half of which are undiagnosed. According to the International Headache Society’s diagnostic criteria, migraine is characterized by recurrent headaches which, if untreated, typically last four to 72 hours, with symptoms including moderate to severe headache pain, throbbing head pain, head pain located on one side of the head, head pain aggravated by routine activity, nausea, vomiting, and sensitivity to light and sound.

    In the past, many clinicians believed that migraine was a vascular condition, induced by blood vessel dilation alone. Today, new insight suggests that migraine is much more complex, involving a chain of events that are both neurovascular and inflammatory. Treximet contains sumatriptan that mediates vasoconstriction, which correlates with the relief of migraine headache. It also contains naproxen, an anti-inflammatory agent. Therefore, sumatriptan and naproxen sodium contribute to the relief of migraine through pharmacologically different mechanisms of action.

    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 mthysergide) 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.

SOURCE GlaxoSmithKline

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