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New Data Show Peak Concentration of Sumatriptan Occurred Earlier With Sumatriptan Succinate/Naproxen Sodium Combination Compared to Sumatriptan Succinate

Data Also Show Comparable Blood Levels of Sumatriptan in Trexima Compared to Imitrex

LONDON, UK -- September 20, 2006 -- For migraine sufferers, the rate at which their migraine medications are absorbed into the blood stream may make a difference in how fast the medicines work. Now, according to new data, the median of the differences indicated that sumatriptan reached peak blood levels 53 minutes earlier with Trexima compared to Imitrex.

The study, presented today at the 16th Migraine Trust International Symposium in London, compared the blood levels of sumatriptan when taken in Imitrex and when taken in Trexima, which combines sumatriptan with naproxen sodium.

The data show that the blood levels during the two hours after dosing (early exposure) and peak blood level of the 85 mg dose of sumatriptan in Trexima and the 100 mg dose of sumatriptan in Imitrex were not significantly different, although the peak level was achieved faster with Trexima.

Trexima. the proposed brand name for a single tablet containing sumatriptan 85 mg as the succinate salt, formulated with RT Technology(TM), and naproxen sodium 500 mg. is currently under review by the United States Food and Drug Administration (FDA) for the acute treatment of migraine. RT Technology, currently only available in Imitrex Tablets, is an innovative tablet formulation designed to rapidly disintegrate and disperse in the stomach after swallowing, which may allow the medicine to be absorbed more quickly into the blood stream.

About the Study
A single-center, randomized, open-label two-way cross over bioavailability study in 32 healthy adult volunteers was conducted. (Bioavailability is the degree to which, or rate at which, a medication is absorbed after administration.) This study evaluated the pharmacokinetics of sumatriptan following a single oral dose of 85 mg sumatriptan and 500 mg naproxen sodium compared to a single oral dose of 100 mg Imitrex, the most commonly prescribed dose of Imitrex.

Following each dose, blood samples were analyzed for drug concentrations at multiple times. The differences in each patient's time to peak blood levels of sumatriptan for Imitrex and Trexima were determined. The median of the differences across the entire study population was 53 minutes.

About Migraines
Migraines affect 28 million Americans, approximately half of whom remain undiagnosed. Symptoms of migraine can vary from attack to attack in the same person, and different people may exhibit different symptoms. Because relief can mean the difference between debilitating pain and the ability to resume activities of daily life, it is important for migraine sufferers to have a variety of treatment options.

According to the American Migraine Study II, one of the top desires of migraine patients is rapid onset of relief from their migraine medicine. It is important that migraine sufferers treat at the first sign of pain, so they can get back to their life more quickly.

About Imitrex(R) (sumatriptan succinate) Tablets
Imitrex is a prescription medication indicated for the acute treatment of 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 are a smoker, 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.

About Naproxen Sodium
Naproxen sodium is a non-steroidal anti-inflammatory drug (NSAID) and is contained in Anaprox(R), Anaprox DS(R), Naprelan(R), Aleve(R) 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 in whom aspirin or other NSAIDs induce the syndrome of asthma, rhinitis, and nasal polyps. 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.

POZEN, Inc. sponsored and GlaxoSmithKline supported these studies.


SOURCE: POZEN; GlaxoSmithKline

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