|New Data Show Investigational Migraine Therapy Demonstrates Effective Treatment of Migraine-Associated Neck and Sinus Pain|
Single Tablet Combination Therapy Containing Sumatriptan Formulated With
RT Technology(TM) and Naproxen Sodium Provides Rapid and Sustained Relief
LOS ANGELES, June 26, 2006 /PRNewswire-FirstCall/ -- (NYSE: GSK; Nasdaq: POZN) An investigational migraine treatment demonstrates effective treatment of migraine-associated neck pain/discomfort and sinus pain/pressure, according to new data presented at the Annual Meeting of the American Headache Society (AHS) in Los Angeles. In addition, use of the compound was statistically superior in producing pain-free rates as early as 30 minutes. Furthermore, significantly more patients reached pain-free status at two hours; this result was sustained for 24 hours without the use of additional medicine. This single tablet combination therapy -- currently under review with the U.S. Food and Drug Administration (FDA) under the proposed trade name Trexima(TM) -- contains sumatriptan 85 mg, as the succinate salt, formulated with RT Technology(TM), and naproxen sodium 500 mg.
"These data suggest that a single treatment designed to target multiple mechanisms of migraine may be an effective option for many patients," said Stephen Silberstein, MD, director of the Jefferson Headache Center and lead study investigator. "In particular, we're excited because these studies show promise at treating associated symptoms of migraine such as neck pain and discomfort and sinus pain and pressure, which can be difficult to alleviate."
Recent data indicate 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. 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.
About the Studies
The studies evaluated the efficacy and tolerability of sumatriptan 85mg, formulated with RT Technology(TM), and naproxen sodium 500 mg versus placebo for the treatment of mild migraine pain. The data were derived from two identical randomized, multi-center, double-blind, placebo-controlled parallel group, single attack (treating mild pain within one hour of onset) trials of adult migraineurs in the U.S. Study results indicated:
-- Neck pain and discomfort decreased significantly at two hours for the compound versus placebo in study 1 (35 and 44 percent) and study 2 (28 and 54 percent). -- Sinus pain and pressure decreased significantly at two hours for the compound versus placebo in study 1 (19 and 33 percent) and study 2 (23 and 38 percent).(1) -- More patients were pain free at two hours in both studies (52 and 51 percent) compared to placebo (17 and 15 percent) and sustained pain-free response was maintained for significantly more patients (45 and 40 percent), without the use of a rescue medication, to 24 hours, compared to placebo (12 and 14 percent). -- The compound was effective in rapidly eliminating migraine pain, as measured by pain-free rates at 30 minutes, one hour, two hours and four hours. -- Incidence of migraine associated symptoms (nausea, phonophobia (sensitivity to sound) and photophobia (sensitivity to light)) was lower with the compound than with placebo. -- The compound was generally well-tolerated. In both studies, only nausea (3 and 4 percent) and dizziness (1 and 2 percent) were reported in at least 2 percent of patients who took the compound versus placebo (1 and 2 percent for nausea, 0 and < 1 percent for dizziness).
"This data illustrates how the new understanding of migraine pathophysiology is leading to the development of effective treatments with an early and sustained effect," continued Dr. Silberstein.
Multiple Mechanisms of Migraine
Understanding the multiple mechanisms of migraine may 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.
GlaxoSmithKline (NYSE: GSK) -- 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 (Nasdaq: POZN) 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.
SOURCE: POZEN Inc.; GlaxoSmithKline
CONTACT: GSK US Media, Robin Gaitens, +1-919-483-2839, or GSK US Analyst-Investor, Frank Murdolo, +1-215-751-7002, or Tom Curry, +1-215-751-5419; or POZEN Inc. Investor, Bill Hodges, Chief Financial Officer, +1-919-913-1030, or Fran Barsky, Director, Investor Relations, +1-919-913-1044, or POZEN Inc. Media, Andrea Johnston, Pure Communications, +1-910-681-1088