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New Pivotal Trial Data Demonstrated Superior Clinical Benefits of Single Tablet Containing Sumatriptan Formulated With RT Technology(TM) and Naproxen Sodium

Single Tablet Designed to Target Multiple Mechanisms of Migraine

SAN DIEGO, April 5 /PRNewswire-FirstCall/ -- A single tablet containing sumatriptan 85 mg as the succinate salt, formulated with RT Technology, and naproxen sodium 500 mg showed superior results in treating acute migraine pain compared to use of sumatriptan alone or placebo, according to new data presented today at the 58th Annual Meeting of the American Academy of Neurology (AAN) in San Diego. Findings from two identical studies including more than 2,800 migraine sufferers showed more patients in the sumatriptan/naproxen sodium arm reported pain relief at two hours and four hours, compared to sumatriptan alone or placebo.

Recent data suggest that the pathophysiology of migraine is complex and that migraine is not merely a vascular problem, but a result of a chain of events that are both vascular and neurological. These events develop early in the migraine process, often long before a patient actually feels the sensation of headache pain.

"We now have a better understanding of how a migraine develops in the brain, enabling us to develop new therapies that target multiple mechanisms," said Dr. Stephen Silberstein, professor of neurology and director of the Jefferson Headache Center at Thomas Jefferson University. "Current treatments do not address all of the mechanisms of migraine that produce symptoms. The product evaluated in these studies is designed to target multiple mechanisms of migraine."

About the Studies

The studies evaluated the efficacy and tolerability of an acute migraine treatment currently under review by the United States Food and Drug Administration under the proposed trade name Trexima(TM) (sumatriptan succinate/naproxen sodium). The data were derived from two identical randomized, double-blind, placebo controlled parallel group, single attack multicenter studies of adult migraineurs in the U.S. Study results indicated:

  • The compound was more effective than either sumatriptan 85 mg formulated with RT Technology alone or placebo for pain relief at two hours in study 1 (57%, 50%, 29% respectively) and also in study 2 (65%, 55%, 28% respectively).
  • The compound was more effective than either sumatriptan 85 mg formulated with RT Technology alone or placebo for pain relief at four hours in study 1 (72%, 61%, 37% respectively) and in study 2 (78%, 66%, 37% respectively).
  • In comparisons with placebo, the compound resulted in lower rates of associated symptoms of migraine - photophobia, phonophobia and nausea - at two hours after dosing. These results were statistically significant with the exception of nausea incidence in study 1 where a baseline imbalance in the incidence of nausea was present.
  • The most commonly reported adverse events with the compound were dizziness (4%), somnolence (3%), nausea (3%), tingling (2%), dyspepsia (2%), dry mouth (2%) and chest discomfort (2%).
Multiple Mechanisms of Migraine

Migraine pain is believed to be induced not only by the widening of blood vessels, or vasodilation, but also by inflammation, leading to nociception (perception of pain) and central and peripheral sensitization.

Understanding the multiple mechanisms of migraine may also explain why migraine sufferers often experience different types of symptoms. For example, during a migraine, stimulation of the trigeminal nerve (fifth cranial nerve, carrying sensory information from the face) may cause referral of pain to any of the nerve's three branches, resulting in facial pain. It can also cause referral of pain to the sensory nerves of the posterior head and neck, resulting in neck pain.

"Medications like triptans treat migraines by preventing the release of inflammatory substances and pain transmitting signals, but they do not address initial inflammation, which is essentially where the migraine begins," said Dr. Silberstein. "A therapy that both inhibits inflammation and treats pain may address multiple mechanisms of migraine."

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.

About GlaxoSmithKline

GlaxoSmithKline (NYSE: GSK) - 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: www.gsk.com.

About POZEN

POZEN (Nasdaq: POZN) 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 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: www.pozen.com.

Pozen, Inc. sponsored and GlaxoSmithKline supported these studies.

SOURCE GlaxoSmithKline; Pozen, Inc.

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