Healthcare Industry News: Trexima
News Release - June 9, 2006
POZEN Inc. and GlaxoSmithKline Report Receipt of Approvable Letter for Investigational Migraine TreatmentCHAPEL HILL and RESEARCH TRIANGLE PARK, N.C., June 9 (HSMN NewsFeed) -- POZEN Inc. (Nasdaq: POZN ) and GlaxoSmithKline (NYSE: GSK ) announced today that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for Trexima(TM). An approvable letter is an official notification from the FDA that contains conditions that must be satisfied prior to obtaining final U.S. marketing approval.
The FDA has determined that Trexima is effective as an acute treatment for migraine headaches. The Agency has requested additional safety information on Trexima, which may require new studies. POZEN and GSK intend to request a meeting with the FDA as quickly as possible to discuss the approvable letter and determine the appropriate next steps to gain full approval.
Trexima, the proposed brand name for the product candidate combining sumatriptan 85 mg, as the succinate salt, formulated with RT Technology(TM) and naproxen sodium 500 mg in a single tablet, is the first product designed to treat multiple mechanisms of migraine: inflammation and vasodilation.
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.
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. POZEN's efforts are focused 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 .
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