Trexima(TM) (Sumatriptan/Naproxen Sodium) Superior Efficacy Data Published in JAMA

Trexima provided superior sustained pain-free results compared to

sumatriptan



RESEARCH TRIANGLE PARK and CHAPEL HILL, N.C., April 3

/PRNewswire-FirstCall/ -- ( GSK) ( POZN) -- Findings from two
 pivotal efficacy studies of more than 2,900 migraine sufferers demonstrated
 that Trexima(TM) provided superior headache relief at two hours and four
 hours compared to placebo, and two through 24-hour sustained pain-free
 results versus sumatriptan or naproxen monotherapy. The results were
 published today in the Journal of the American Medical Association (JAMA).
     "Recent research suggests that migraine is more complex than previously
 believed, consisting of multiple mechanisms that each contribute to
 migraine pain in different ways," said lead author Jan Lewis Brandes, M.D.,
 assistant clinical professor at Vanderbilt University School of Medicine
 and director of the Nashville Neuroscience Group. "These studies found that
 Trexima, which is the first migraine-specific product designed to treat
 both inflammation and vasodilation in a single tablet, provided superior
 efficacy compared to placebo and its individual components."
     Trexima is the proposed brand name for a single tablet containing
 sumatriptan 85 mg as the succinate salt, formulated with RT Technology(TM),
 and naproxen sodium 500 mg, for the acute treatment of migraine. These
 studies were the pivotal efficacy studies included in the New Drug
 Application currently under review by the FDA.
     Trexima: Both Early and Sustained Relief
     To help evaluate the efficacy and safety of Trexima, two randomized,
 double-blind, parallel-group, placebo-controlled single-attack studies were
 conducted in 118 sites in the United States. A total of 3,413 patients were
 randomized to receive a single Trexima tablet, a single tablet containing
 sumatriptan 85 mg formulated with RT Technology(TM), a single tablet
 containing naproxen sodium 500 mg, or placebo. If patients did not achieve
 headache relief within two hours, they were permitted to use rescue
 medication (defined as one dose of non-study medicine prescribed or
 recommended by a physician). Efficacy data were reported from 2,911
 patients who treated one attack each.
     There were two objectives of these studies. The first was to evaluate
 the efficacy of Trexima at two hours post-dose versus placebo on the
 following variables:
      -- Headache relief
      -- Absence of phonophobia (sensitivity to sound)
      -- Absence of photophobia (sensitivity to light)
      -- Absence of nausea
     The second objective was to assess the sustained effect of Trexima from
 two through 24 hours compared to sumatriptan or naproxen sodium alone.
     In Study 1, Trexima demonstrated superiority for all primary endpoints.
 In Study 2, Trexima demonstrated superiority for the primary endpoints,
 with the exception of the incidence of nausea-free at two hours. Trexima
 did reach statistical significance for sustained nausea-free two through 24
 hours compared to placebo.
     Significantly fewer patients on Trexima (only 22 percent in Study 1, 23
 percent in Study 2) required use of rescue medication compared to
 sumatriptan (32 percent in Study 1, 38 percent in Study 2).
     Trexima was generally well-tolerated in these studies. No serious
 adverse events (defined as resulting in hospitalization or death) were
 reported in either study for patients taking Trexima. The most common
 adverse effects in patients taking Trexima were dizziness (5 percent in
 Study 1; 3 percent in Study 2), somnolence (3 percent/4 percent), nausea (3
 percent/4 percent) and paresthesia (3 percent/2 percent), dyspepsia (3
 percent in Study 2 only), dry mouth (2 percent/2 percent) and chest
 discomfort (2 percent in Study 1 only.)
     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 tendonitis, 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, migraine or 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 this study.
 
 

SOURCE GlaxoSmithKline; POZEN