RESEARCH TRIANGLE PARK and CHAPEL HILL, N.C., April 03, 2007 /PRNewswire-FirstCall/ -- -- Findings from two pivotal efficacy studies of more than 2,900 migraine sufferers demonstrated that Trexima(TM) provided superior headache relief at two hours and four hours compared to placebo, and two through 24-hour sustained pain-free results versus sumatriptan or naproxen monotherapy. The results were published today in the Journal of the American Medical Association (JAMA).
"Recent research suggests that migraine is more complex than previously believed, consisting of multiple mechanisms that each contribute to migraine pain in different ways," said lead author Jan Lewis Brandes, M.D., assistant clinical professor at Vanderbilt University School of Medicine and director of the Nashville Neuroscience Group. "These studies found that Trexima, which is the first migraine-specific product designed to treat both inflammation and vasodilation in a single tablet, provided superior efficacy compared to placebo and its individual components."
Trexima is 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, for the acute treatment of migraine. These studies were the pivotal efficacy studies included in the New Drug Application currently under review by the FDA.
Trexima: Both Early and Sustained Relief
To help evaluate the efficacy and safety of Trexima, two randomized, double-blind, parallel-group, placebo-controlled single-attack studies were conducted in 118 sites in the United States. A total of 3,413 patients were randomized to receive a single Trexima tablet, a single tablet containing sumatriptan 85 mg formulated with RT Technology(TM), a single tablet containing naproxen sodium 500 mg, or placebo. If patients did not achieve headache relief within two hours, they were permitted to use rescue medication (defined as one dose of non-study medicine prescribed or recommended by a physician). Efficacy data were reported from 2,911 patients who treated one attack each.
There were two objectives of these studies. The first was to evaluate the efficacy of Trexima at two hours post-dose versus placebo on the following variables:
-- Headache relief -- Absence of phonophobia (sensitivity to sound) -- Absence of photophobia (sensitivity to light) -- Absence of nausea
The second objective was to assess the sustained effect of Trexima from two through 24 hours compared to sumatriptan or naproxen sodium alone.
In Study 1, Trexima demonstrated superiority for all primary endpoints. In Study 2, Trexima demonstrated superiority for the primary endpoints, with the exception of the incidence of nausea-free at two hours. Trexima did reach statistical significance for sustained nausea-free two through 24 hours compared to placebo.
Significantly fewer patients on Trexima (only 22 percent in Study 1, 23 percent in Study 2) required use of rescue medication compared to sumatriptan (32 percent in Study 1, 38 percent in Study 2).
Trexima was generally well-tolerated in these studies. No serious adverse events (defined as resulting in hospitalization or death) were reported in either study for patients taking Trexima. The most common adverse effects in patients taking Trexima were dizziness (5 percent in Study 1; 3 percent in Study 2), somnolence (3 percent/4 percent), nausea (3 percent/4 percent) and paresthesia (3 percent/2 percent), dyspepsia (3 percent in Study 2 only), dry mouth (2 percent/2 percent) and chest discomfort (2 percent in Study 1 only.)
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 tendonitis, 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 i n 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.
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 .
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 or 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 this study.
CONTACT: GSK US Media, Robin Gaitens, +1-919-483-2839, or GSK USAnalysts-Investors, Frank Murdolo, +1-215-751-7002, or Tom Curry,+1-215-751-5419; or POZEN, Inc. Investors, Bill Hodges, Chief FinancialOfficer, +1-919-913-1030, or Fran Barsky, Director, Investor Relations,+1-919-913-1044, or POZEN, Inc. Media, Andrea Johnston, PureCommunications, +1-910-681-1088
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