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Phase 3 Trial of Sumatriptan/Naproxen Combination Launched
The Phase III program will begin immediately. POZEN will conduct two Phase III pivotal trials, designed to determine the effectiveness and safety of Trexima for the acute treatment of migraine. In addition, POZEN will conduct a long-term, open label safety study.
"Moving into Phase III is a major step in the development of this important new medicine," said Stan Hull, GSK Senior Vice President, US Pharmaceuticals. "GSK has long been a leader in discovering and developing migraine treatments, and we are pleased to be working with POZEN to move Trexima into the final stage of development."
"We look forward to a rapid development program for Trexima, with a targeted NDA filing in the second half of 2005. We believe Trexima, which uses POZEN's MT 400(TM) technology, has the potential to be one of the best treatments for migraine," said John R. Plachetka, Pharm.D., POZEN's Chairman, President and Chief Executive Officer.
POZEN and GSK signed an agreement in June 2003 for the development and commercialization of proprietary combinations of a triptan (5-HT1B/1D agonist) and a non-steroidal anti-inflammatory drug (NSAID), including the combination that makes up Trexima. Under the agreement, POZEN is responsible for the pre-clinical, clinical, and regulatory development activities for Trexima, while GSK is responsible for formulation development, manufacturing and commercialization. The commencement of the Phase III program will trigger a $15 million development milestone payment to POZEN by GSK. The companies expect the New Drug Application (NDA) for Trexima to be filed in the second half of 2005.
Migraine afflicts approximately 28 million people in the United States alone, of which roughly three out of four migraine sufferers are women. Migraine attacks can last from 4 hours to 72 hours and are typically characterized by sharp pulsating pain on one side of the head, nausea, and extreme sensitivity to light and sound. While the precise mechanism of migraine is unknown, researchers believe migraine attacks are caused by acute inflammation surrounding selected vessels in the head. The average migraine sufferer experiences the first attack during the early teen years, and the attacks generally continue throughout adulthood.
Imitrex (sumatriptan) tablets are approved for the acute treatment of migraines with or without aura in adults and are available by prescription in pharmacies nationwide. Imitrex should only be used when a clear diagnosis of migraine has been established by a physician. 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. 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: Pozen and GlaxoSmithKline