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Study Newly Published in Mayo Clinic Proceedings Demonstrated Long-Term Safety and Tolerability of Trexima(TM) (Sumatriptan/Naproxen Sodium) for Acute Treatment of Migraine

Data from Almost 25,000 Migraine Attacks Show Trexima Was Generally Well Tolerated

RESEARCH TRIANGLE PARK, NC, and CHAPEL HILL, NC -- January 30, 2007 -- Long-term safety and tolerability are important attributes for migraine medicines as migraine attacks can affect sufferers for many years. In a study published in the current issue of Mayo Clinic Proceedings, the investigational migraine therapy Trexima (sumatriptan/naproxen sodium) was generally well tolerated when used repeatedly for the acute treatment of migraine headaches in adults over a period of up to one year.

In this large, multi-center, open-label safety study, 565 migraine patients treated almost 25,000 migraine attacks. According to Paul Winner, DO, FAAN, lead author of the study and director of the Palm Beach Headache Center in Florida, the study authors concluded that the adverse events reported with Trexima did not differ from those expected for the individual components alone and there were no new or unexpected safety findings.

Trexima is the proposed brand name for a single tablet containing sumatriptan 85 mg as the succinate salt, formulated with RT Technology™, and naproxen sodium 500 mg, for the acute treatment of migraines in adults. The findings from this study are included in the New Drug Application, currently under review by the FDA.

About the Study
The data were derived from an open-label, 12-month safety study conducted at 39 sites across the U.S. Of the 565 patients who treated at least one migraine attack with Trexima, 414 completed 6 months of treatment and 362 completed 12 months of treatment. Patients who completed the study treated on average five attacks per month. Doses of Trexima per attack in the second 6 months were comparable to those in the first 6 months of the study, indicating no reduction of therapeutic effect over the 12-month period. If the first dose did not produce adequate relief, patients were permitted to take a second dose two hours later; 70 percent of migraine attacks were treated with just one dose. Patients were provided with diaries to record any medications taken during the 24 hours prior to and after the migraine, as well as any adverse events.

No new or unexpected adverse events were reported by study participants. Most of the patients who reported adverse events described them as mild or moderate in severity. The most common treatment-related adverse events reported within 24 hours of taking a single tablet of Trexima were nausea (6 percent), muscle tightness (3 percent), and dizziness (3 percent). There was no significant difference in the rates of adverse events reported when attacks were treated with
two tablets versus one tablet. Fewer than 3 percent of patients experienced a serious adverse
event (defined as an event resulting in hospitalization or death); one event was labeled as probably treatment related. No events were life-threatening.

About Migraines
More than 28 million Americans suffer from migraines, yet under-diagnosis and misdiagnosis of the condition remains a problem. It is estimated that as many as 14 million people who have migraines have never been diagnosed by a physician. Migraine can lead to missed days of work, lost time with family and friends, and a disrupted daily routine.

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.

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.



SOURCE: GlaxoSmithKline and Pozen

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