Trexima (Sumatriptan/Naproxen Sodium) Demonstrated Efficacy Across Multiple Migraine AttacksStudy Results Show Individuals Reported Consistent Pain-Free Results From Attack to Attack
BOSTON, May 02, 2007 /PRNewswire/ -- Patients who suffer from migraines frequently cite inconsistent effectiveness as a reason for their dissatisfaction with their medicine. New data from more than 1,100 patients show that the investigational migraine therapy Trexima, when taken early, produced pain-free results at two and four hours, as well as a sustained pain- free response 2-24 hours, across individual patients' multiple migraine attacks, demonstrating the consistency in efficacy that patients desire. Furthermore, nearly one third of all patients were pain free at two hours. These findings were presented today at the 59th Annual Meeting of the American Academy of Neurology.
"The anticipation of the next attack can be quite stressful for patients," said Richard Lipton, MD, Professor of Neurology, Epidemiology and Social Medicine, Albert Einstein College of Medicine in New York. "Patients want a treatment that works quickly and provides consistent relief for each attack. These data are significant because they show that Trexima produced consistent pain-free results across multiple attacks in the same patient."
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 FDA for the acute treatment of migraines in adults.
About the Studies
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. Patients were randomized to one of five groups and instructed to treat four migraine attacks. Most patients (80 percent) treated three of four attacks with Trexima and the remaining attack with placebo; the remaining patients treated all four attacks with Trexima.
In both studies, Trexima produced a consistent response from attack to attack experienced by individual study participants. In patients treating three attacks with Trexima, more than half of patients taking Trexima were pain free at two hours, more than three-quarters were pain-free at four hours, and about one-third achieved a sustained pain free response in at least two attacks; 29 percent were pain-free at two hours in all three attacks. Similar findings were reported among patients who treated all four attacks with Trexima.
As further evidence of the consistent response with Trexima, of patients who were pain free at two and four hours during the first attack, more than seven in 10 were pain-free in the second attack.
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 may 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.
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 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/
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Posted: May 2007