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New Analysis Shows Patients Who Treat Their Migraine Pain Early With Trexima™ (Sumatriptan Succinate/Naproxen Sodium) Have Higher Sustained Pain-Free Rates Than Those Who Treat Late

Patients Who Treated Early Were More Likely to be Pain-free from 2 Through 24 Hours

LONDON, Sept. 20 /PRNewswire-FirstCall/ -- (NYSE: GSK - News; Nasdaq: POZN - News) -- Migraine sufferers frequently cite lack of recurrence of migraine symptoms as one of the most desired attributes of an acute migraine treatment. Now, a new analysis of four studies showed that patients who treated their migraines with Trexima while pain was mild and within one hour of the start of pain were nearly twice as likely to be pain free at 2 hours, and remain pain free through 24 hours, than those who waited until the pain was more severe. These findings were presented today at the 16th Migraine Trust International Symposium in London.

"Patients are often hesitant to treat their migraine early as they are concerned that the medicine will wear off and their symptoms will return. These results are exciting because they may help dispel this myth." said Jan Lewis Brandes, MD, director of the Nashville Neurosciences Institute and lead study investigator. "These findings show that by treating a migraine early with a product like Trexima patients are more likely to still be pain free 24-hours later than if they wait to treat in the later stages of a migraine."

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 500mg, is currently under review by the United States Food and Drug Administration (FDA) for the acute treatment of migraines in adults.

Migraine pain is believed to be induced not only by the widening of blood vessels, or vasodilation, but also by inflammation, leading to increased nociception (perception of pain) and sensitization of nerves. This complex sequence of events occurs long before patients feel pain and take their medication.

About the Studies

Data were derived from identical, randomized, multi-center, double-blind, placebo controlled studies. This analysis evaluated sustained pain-free responses, defined as pain free at 2 hours and maintained through 24 hours, in these studies.

Two studies evaluated the clinical benefits of treating migraine early (while pain was mild and within one hour of the start of pain) with sumatriptan/naproxen sodium or placebo. These findings showed:

  • Significantly more patients who treated with sumatriptan/naproxen sodium achieved a sustained pain-free response (45 percent and 40 percent) compared to patients who received placebo (12 percent and 14 percent).

Two studies evaluated the benefits of treating migraine late (when pain is moderate to severe) with sumatriptan/naproxen sodium; 85 mg of sumatriptan, formulated with RT Technology; 500 mg of naproxen sodium; or placebo.

  • Significantly more patients who treated with sumatriptan/naproxen sodium achieved a sustained pain-free response (23 percent and 25 percent) compared to patients who treated with sumatriptan alone (14 percent and 16 percent), naproxen sodium alone (10 percent and 10 percent), or placebo (7 percent and 8 percent).1

Sumatriptan/naproxen sodium was well-tolerated in all four studies. The most common adverse events were dizziness, somnolence, nausea, tingling, dry mouth, dyspepsia, and chest discomfort.

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® (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®, 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 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.

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: http://www.gsk.com .

About POZEN

POZEN is a pharmaceutical company committed to developing therapeutic advancements for diseases with unmet medical needs where it can improve efficacy, safety, and/or patient convenience. POZEN's efforts are focused primarily on the development of pharmaceutical products for the treatment of acute and chronic pain and other pain-related conditions. POZEN has development and commercialization alliances with GlaxoSmithKline and AstraZeneca. The company's common stock is traded on The NASDAQ Stock Market under the symbol "POZN". For detailed company information, including copies of this and other press releases, see POZEN's website: http://www.pozen.com .

POZEN, Inc. sponsored and GlaxoSmithKline supported these studies.

Source: POZEN; GlaxoSmithKline