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New Data Show Consistent Efficacy and Tolerability of Trexima™ (Sumatriptan Succinate/Naproxen Sodium) Across Multiple Migraine Attacks

Data from a Separate Study Also Highlight the Need for New Migraine Treatments that Better Meet Patients' Needs

LONDON, Sept. 20 /PRNewswire-FirstCall/ -- (NYSE: GSK - News; Nasdaq: POZN - News) -- New data examining more than 4,200 migraine attacks in more than 1,100 patients demonstrated that Trexima delivered consistent efficacy over multiple migraine attacks. The findings, presented today at the 16th Migraine Trust International Symposium in London, suggest Trexima may address an unmet need among migraine sufferers, who frequently cite inconsistent effectiveness as a reason for their dissatisfaction with their medicine. Additionally, Trexima was generally well tolerated across both studies.

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 migraines in adults.

"While current therapies may be efficacious for many patients, we know that consistency across migraine attacks continues to be a problem for some," said Richard Lipton, MD, professor of Neurology, Epidemiology and Social Medicine, Albert Einstein College of Medicine in New York. "These study results are significant because they demonstrated that treatment with this therapy was consistent across multiple attacks in a large number of patients."

The desire for treatments that better meet migraine patients' needs was underscored in other data presented at the Symposium. The Migraine Assessment of Current Therapy (ACT), an office-based questionnaire, was administered to 418 migraine patients to assess whether their medication works consistently, relieves pain within two hours, allows normal functioning within two hours, and enables enough comfort to plan daily activities. Respondents were categorized by primary therapy, including triptans, barbiturates, opioids, prescription NSAIDs or OTC analgesics, isometheptene, dichloralphenazone, and acetaminophen (IDA) combinations, and other. Results showed that while patients taking triptans had the best responses, there is still room for improvement.

About the Studies

Consistent Efficacy Across Four Migraine Attacks

Two identical cross-over clinical trials were conducted in adults with multiple migraine attacks. The trials were randomized, multi-center, double- blind, placebo-controlled, and utilized early intervention (treating mild migraine pain and within one hour of the start of pain).

Subjects were randomized to one of five treatment sequences and instructed to treat four migraine attacks. Patients in four groups received sumatriptan/naproxen sodium in three of four attacks and placebo in the remaining attack. Patients in the fifth group received sumatriptan/naproxen sodium for all four attacks. The primary analyses used repeated measures techniques across attacks for both pain severity at two hours and sustained through 24 hours (co-primaries).


    In the first consistency study:
    -- Five hundred and seventy (570) patients treated 1,693 attacks with
       sumatriptan/naproxen sodium and 424 attacks with placebo.
    -- The percentage of patients who were pain free at two hours was
       52 percent and 25 percent (p<0.001) for sumatriptan/naproxen sodium and
       placebo, respectively.
    -- The percentage of patients who were sustained pain free at 24 hours was
       37 percent and 17 percent (p<0.001) for sumatriptan/naproxen sodium and
       placebo, respectively.


    In the second consistency study:
    -- Five-hundred and sixty-five (565) patients treated 1,678 attacks with
       sumatriptan/naproxen sodium and 422 attacks with placebo.
    -- The percentage of patients who were pain free at two hours was
       50 percent and 20 percent (p<0.001) for sumatriptan/naproxen sodium and
       placebo, respectively.
    -- The percentage of patients who were sustained pain free at 24 hours was
       34 percent and 12 percent (p<0.001) for sumatriptan/naproxen sodium and
       placebo, respectively.

Adverse events were generally mild with the most common being dry mouth, nausea, and dizziness across all attacks treated in both studies. No serious drug-related adverse events were reported.

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.

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 sumatriptan. 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