Trexima (Sumatriptan/Naproxen Sodium) Provided Relief of Both Traditional and Non-traditional Migraine Symptoms

New data show efficacy across the range of migraine symptoms

BOSTON, May 02, 2007 /PRNewswire/ -- While many migraine sufferers experience traditional symptoms such as nausea or sensitivity to light and sound, migraine attacks can also involve symptoms like neck pain or sinus pain that are not traditionally associated with migraine headaches. New data show that significantly more patients using the investigational migraine treatment Trexima early in their migraine attacks were pain free at two hours and experienced relief from both traditional and non-traditional symptoms, compared to patients taking placebo. These data were presented today at the 59th Annual Meeting of the American Academy of Neurology.

In these studies, more than 1,100 patients treated more than 3,300 migraine attacks. At the beginning of the studies, many patients experienced traditional migraine symptoms: nausea (27-33 percent), sensitivity to light (69-74 percent) and sensitivity to sound (62-69 percent). Additionally, many patients also reported the non-traditional migraine-associated symptoms of sinus pain/pressure (39-44 percent) or neck pain/discomfort (59-61 percent).

"One of the challenges in migraine treatment is helping patients get relief for the specific symptoms associated with each attack," said Robert Kaniecki, MD, director of the Headache Center at the University of Pittsburgh. "These data are important because for the first time we have evidence of efficacy in treating both traditional and non-traditional migraine-associated symptoms across multiple migraine attacks."

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 US Food and Drug Administration for the acute treatment of migraines in adults.

Understanding the Multiple Mechanisms of Migraine

Migraine pain is believed to be induced not only by the widening of the blood vessels, or vasodilation, but also involves neurochemical release and prostaglandin production. These mechanisms lead to inflammation, resulting in increased pain perception and sensitization of nerves. Understanding the multiple mechanisms of migraine may also explain why migraine sufferers often experience a variety of non-traditional migraine symptoms in addition to head pain, nausea or vomiting, and sensitivity to light and sound. Stimulation of the main sensory nerve may cause referral of pain to any of the nerve's three branches, resulting in sinus or facial pain; it may also cause referral of pain to the sensory nerves of the posterior head and neck, resulting in neck pain.

Relief from Non-Traditional and Traditional Migraine Symptoms

The data are from two identical multi-center, double-blind, placebo- controlled cross-over studies of adult migraine sufferers. The study incorporated an early intervention model, in which patients were instructed to treat while migraine pain was mild and within one hour of onset. Endpoints included post-treatment incidence of traditional symptoms, defined as nausea, vomiting, photophobia (sensitivity to light) and phonophobia (sensitivity to noise); and non-traditional symptoms, defined as sinus pain/pressure and neck pain/discomfort. Response to these symptoms was measured at two and four hours. This is the first study to evaluate traditional and non-traditional migraine-associated symptoms in a controlled early intervention setting across multiple attacks.

In both studies, patients taking Trexima reported a significantly lower incidence of traditional and non-traditional migraine-associated symptoms compared to placebo at two and at four hours.

    -- The approximate difference between Trexima and placebo at two hours for

       each symptom was as follows: nausea (6 percent), sensitivity to light

       (22 percent), sensitivity to sound (18 percent), sinus pain/pressure

       (14 percent) and neck pain/discomfort (10 percent).

    -- The approximate difference between Trexima and placebo at four hours

       for each symptom was as follows: nausea (12 percent), sensitivity to

       light (26 percent), sensitivity to sound (24 percent), sinus

       pain/pressure (16 percent) and neck pain/discomfort (16 percent).

In more than 1,100 patients treating more than 3,300 attacks, adverse events reported in at least 2 percent of patients within 72 hours of taking Trexima were nausea, dizziness, dry mouth, somnolence and fatigue.

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 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.

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 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.

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. Since its inception, POZEN has focused its efforts primarily on the development of pharmaceutical products for the treatment of acute and chronic pain, migraine and other pain related conditions. POZEN is also exploring the development of product candidates in other pain-related therapeutic areas. POZEN has a development and a commercialization alliance with GlaxoSmithKline. 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.

CONTACT: GSK US Media, Robin Gaitens, +1-919-483-2839, GSK US Analyst-Investor, Frank Murdolo, +1-215-751-7002, or Tom Curry, +1-215-751-5419,POZEN Inc. Investor, Bill Hodges, Chief Financial Officer, +1-919-913-1030,or Fran Barsky, Director, Investor Relations, +1-919-913-1044, POZEN Inc.Media, Andrea Johnston, Pure Communications, +1-910-681-1088

Web site: http://www.pozen.com/http://www.gsk.com/

Ticker Symbol: (:POZN)

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Posted: May 2007

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