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New Data Show Investigational Migraine Therapy Demonstrates Effective Treatment of Migraine-Associated Neck and Sinus Pain
6/26/2006

Single Tablet Combination Therapy Containing Sumatriptan Formulated With RT Technology(TM) and Naproxen Sodium Provides Rapid and Sustained Relief

LOS ANGELES, June 26, 2006, 2006 /PRNewswire-FirstCall via COMTEX News Network/ --

(NYSE: GSK; Nasdaq: POZN) An investigational migraine treatment demonstrates effective treatment of migraine-associated neck pain/discomfort and sinus pain/pressure, according to new data presented at the Annual Meeting of the American Headache Society (AHS) in Los Angeles. In addition, use of the compound was statistically superior in producing pain-free rates as early as 30 minutes. Furthermore, significantly more patients reached pain-free status at two hours; this result was sustained for 24 hours without the use of additional medicine. This single tablet combination therapy -- currently under review with the U.S. Food and Drug Administration (FDA) under the proposed trade name Trexima(TM) -- contains sumatriptan 85 mg, as the succinate salt, formulated with RT Technology(TM), and naproxen sodium 500 mg.

"These data suggest that a single treatment designed to target multiple mechanisms of migraine may be an effective option for many patients," said Stephen Silberstein, MD, director of the Jefferson Headache Center and lead study investigator. "In particular, we're excited because these studies show promise at treating associated symptoms of migraine such as neck pain and discomfort and sinus pain and pressure, which can be difficult to alleviate."

Recent data indicate 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. 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.

About the Studies

The studies evaluated the efficacy and tolerability of sumatriptan 85mg, formulated with RT Technology(TM), and naproxen sodium 500 mg versus placebo for the treatment of mild migraine pain. The data were derived from two identical randomized, multi-center, double-blind, placebo-controlled parallel group, single attack (treating mild pain within one hour of onset) trials of adult migraineurs in the U.S. Study results indicated:

-- Neck pain and discomfort decreased significantly at two hours for the
compound versus placebo in study 1 (35 and 44 percent) and study 2
(28 and 54 percent).
-- Sinus pain and pressure decreased significantly at two hours for the
compound versus placebo in study 1 (19 and 33 percent) and study 2
(23 and 38 percent).(1)
-- More patients were pain free at two hours in both studies (52 and
51 percent) compared to placebo (17 and 15 percent) and sustained
pain-free response was maintained for significantly more patients
(45 and 40 percent), without the use of a rescue medication, to
24 hours, compared to placebo (12 and 14 percent).
-- The compound was effective in rapidly eliminating migraine pain, as
measured by pain-free rates at 30 minutes, one hour, two hours and
four hours.
-- Incidence of migraine associated symptoms (nausea, phonophobia
(sensitivity to sound) and photophobia (sensitivity to light)) was
lower with the compound than with placebo.
-- The compound was generally well-tolerated. In both studies, only
nausea (3 and 4 percent) and dizziness (1 and 2 percent) were reported
in at least 2 percent of patients who took the compound versus placebo
(1 and 2 percent for nausea, 0 and < 1 percent for dizziness).


"This data illustrates how the new understanding of migraine pathophysiology is leading to the development of effective treatments with an early and sustained effect," continued Dr. Silberstein.

Multiple Mechanisms of Migraine

Understanding the multiple mechanisms of migraine may 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.

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: http://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 and other pain related conditions. 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 .