LOS ANGELES, June 26, 2006 /PRNewswire-FirstCall/ -- A single tablet combination therapy containing sumatriptan 85 mg, as the succinate salt, formulated with RT Technology(TM), and naproxen sodium 500 mg showed superior sustained pain-free results in treating acute migraine pain compared to use of sumatriptan alone, naproxen sodium alone or placebo, according to new data presented at the Annual Meeting of the American Headache Society (AHS) in Los Angeles. Sustained pain-free was defined as no pain at two hours maintained through 24 hours without use of additional, or rescue, medication. In addition, results showed that patients taking sumatriptan/naproxen sodium needed a rescue medication less often than patients taking sumatriptan alone, naproxen sodium alone or placebo. Findings from two identical studies of migraine sufferers also showed more patients in the sumatriptan/naproxen sodium arm reported pain relief at two hours and four hours compared to sumatriptan alone or placebo.
Recent data suggest 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.
“These data suggest that a therapy designed to target multiple mechanisms of migraine may be an effective treatment option and good news for both physicians and migraine patients, many of whom still have not found a treatment that provides both early and sustained relief,” said Jan Lewis Brandes, MD, director of the Nashville Neurosciences Institute and lead study investigator.
About the Studies
The studies evaluated the clinical efficacy and tolerability of an acute migraine treatment currently under review by the United States Food and Drug Administration (FDA) under the proposed trade name Trexima(TM) (sumatriptan succinate/naproxen sodium). The data were derived from two identical randomized, double-blind, placebo controlled parallel group, single attack multicenter studies of adult migraineurs in the U.S. Study results indicated:
-- The compound was more effective than sumatriptan 85 mg formulated with RT Technology alone, naproxen sodium 500 mg alone or placebo for pain relief at two hours in study 1 (57, 50, 43, 29 percent respectively) and also in study 2 (65, 55, 44, 28 percent respectively). The compound was more effective than sumatriptan 85 mg formulated with RT Technology alone, naproxen 500 mg alone or placebo for pain relief at four hours in study 1 (72, 61, 54, 37 percent respectively) and in study 2 (78, 66, 55, 37 percent respectively). -- The compound was more effective than sumatriptan 85 mg formulated with RT Technology alone, naproxen sodium 500 mg alone or placebo for sustained pain free response (from two to 24 hours) in study 1 (23, 14, 10, 7 percent respectively) and in study 2 (25, 16, 10, 8 percent respectively). -- In comparison to sumatriptan 85 mg formulated with RT Technology alone, naproxen sodium 500 mg alone or placebo, patients in the compound arm were less likely to use as a rescue medication in study 1 (23, 38, 39, 58 percent respectively) and in study 2 (22, 32, 38, 53 percent respectively). -- In comparisons with placebo, the compound resulted in lower rates of associated symptoms of migraine - photophobia, phonophobia and nausea - at two hours after dosing. Data for nausea show a significant reduction with the compound compared to placebo from two to 24 hours. These results were statistically significant with the exception of nausea incidence in study 1 where a baseline imbalance in the incidence of nausea was present. -- All treatments were well-tolerated. The adverse event profile of the compound was similar to those of the individual components. Multiple Mechanisms of Migraine
Migraine pain is believed to be induced not only by the widening of blood vessels, or vasodilation, but also by inflammation, leading to nociception (perception of pain) and central and peripheral sensitization.
Understanding the multiple mechanisms of migraine may also explain why migraine sufferers often experience different types of symptoms. For example, during a migraine, stimulation of the trigeminal nerve (fifth cranial nerve, carrying sensory information from the face) may cause referral of pain to any of the nerve’s three branches, resulting in facial pain. It can also cause referral of pain to the sensory nerves of the posterior head and neck, resulting in neck pain.
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 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.
About GlaxoSmithKline
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 .
About POZEN
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 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 .
Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management’s current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval of our product candidates, including as a result of the need to conduct additional studies, or the failure to obtain such approval of our product candidates, including as a result of changes in regulatory standards or the regulatory environment during the development period of any of our product candidates; uncertainties in clinical trial results or the timing of such trials, resulting in, among other things, an extension in the period over which we recognize deferred revenue or our failure to achieve milestones that would have provided us with revenue; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events, including those discussed herein and in our Quarterly Report on Form 10-Q for the period ended March 31, 2006. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.
POZEN Inc. sponsored and GlaxoSmithKline supported these studies.
POZEN Inc.; GlaxoSmithKline
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