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Trexima Demonstrated Migraine-Free Response Across Multiple Attacks

2007-06-09 00:14

Trexima, when taken early, was nearly twice as effective as placebo in eliminating all traditional migraine symptoms at two and four hours across multiple attacks with just one tablet.

The findings will be presented tomorrow at the 49th Annual Scientific Meeting of the American Headache Society.

In addition to head pain, migraine attacks often include nausea, vomiting and sensitivity to light or sound, making it difficult for sufferers to participate in daily activities. Most migraine studies focus on pain relief or pain-freedom, which only assesses head pain. This is one of the few studies to measure migraine-free response across multiple attacks, which is significant because it means that the associated symptoms of migraine, as well as the head pain, are gone.

"I believe this key endpoint will have more meaning to patients, as it measures when the whole migraine is gone rather than just the head pain," said Dr. Paul Winner, lead author and director of the Palm Beach Headache Center. "In these studies we found Trexima consistently eliminated migraine symptoms in more patients without the need for rescue medication."

Trexima, the proposed brand name for a single tablet containing sumatriptan 85 mg formulated with RT Technology(TM) and naproxen sodium 500 mg, is currently under review by the FDA for the acute treatment of migraines in adults.

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The data are from two identical multi-center, double-blind, placebo- controlled cross-over studies of adult migraine sufferers. Migraine-freeresponse is defined as freedom from migraine pain, nausea, vomiting, sensitivity to light and sound, and without the use of rescue medication at or before the time points specified. Subjects were randomized to one of five sequence groups and instructed to treat four migraine attacks. Patients in four groups received Trexima in three of four attacks and placebo in the remaining attack. Patients in the fifth group received Trexima for all four attacks.

In each study, approximately 40 percent of patients taking Trexima were migraine-free at two hours, compared to about 20 percent on placebo. At four hours, about two-thirds of patients taking Trexima were migraine-free, compared to about one-third of those on placebo.

In more than 1,100 patients treating more than 3,300 attacks, the overall adverse event rate, corrected for attack, was 9 percent and 7 percent in Study 1 and 13 percent and 9 percent in Study 2, for Trexima and placebo, respectively. Adverse events reported in at least 2 percent of patients within 72 hours of taking Trexima were nausea, dizziness, dry mouth, somnolence and fatigue.

Imitrex is a prescription medication indicated for the acute treatmentof migraine in adults. Imitrex should only be used when a clear diagnosis of migraine has been established. Patients should not take Imitrex if they have certain types of heart disease, history of stroke or TIAs, peripheral vascular disease, Raynaud syndrome, or blood pressure that is uncontrolled. Patients with risk factors for heart disease, such as high blood pressure, high cholesterol, diabetes or smoking, should be evaluated by a doctor before taking Imitrex. Very rarely, certain people, even some without heart disease, have had serious heart related problems. Patients who are pregnant, nursing, or taking medications should talk to their doctor.

Naproxen sodium is a non-steroidal anti-inflammatory drug (NSAID) and is contained in Anaprox, Anaprox DS, Naprelan, Aleve and in a number of over-the-counter medications. Naproxen sodium is indicated for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and juvenile arthritis. It is also indicated for the treatment of tendinitis, bursitis, acute gout and for the management of pain and primary dysmenorrhea. Naproxen-containing products should not be used by patients who have had allergic reactions to any product containing naproxen, nor in patients with asthma and nasal polyps in whom aspirin or other NSAIDs induce an exacerbation of asthma. Patients who have a history of peptic ulcer or gastrointestinal bleeding, kidney problems, uncontrolled hypertension or heart failure should consult a physician before using naproxen-containing medications. NSAIDs may cause increased risk of serious cardiovascular thrombotic events, myocardial infarction and stroke. This risk may increase with duration of use and in patients with cardiovascular disease or risk factors for cardiovascular disease. Serious gastrointestinal toxicity such as bleeding, ulceration and perforation can occur at any time in patients treated chronically with NSAID therapy and physicians should remain alert for such effects even in the absence of previous GI tract symptoms. Patients who are pregnant or are nursing should consult a physician before use of a naproxen-containing medication.

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