Press Release

Printer Friendly Version View printer-friendly version
<< Back
New Data Presented on Satisfaction, Productivity and Long-Term Safety of a Single Tablet Containing Sumatriptan Formulated With RT Technology(TM) and Naproxen Sodium

SAN DIEGO, April 5 /PRNewswire-FirstCall/ -- New data from several clinical studies presented at the 58th Annual Meeting of the American Academy of Neurology (AAN) describe multiple benefits of a single tablet containing sumatriptan succinate and naproxen sodium for the acute treatment of migraine headaches. Furthermore, findings from an animal study also presented at AAN support an existing theory that current migraine treatments alone do not address all components of migraine progression.

The results of two clinical studies in migraine sufferers showed that a single tablet containing sumatriptan 85 mg as the succinate salt, formulated with RT Technology, and naproxen sodium 500 mg provides superior results for patient satisfaction and workplace productivity compared to the acute treatment of migraine with either sumatriptan formulated with RT Technology or naproxen sodium alone. In addition, a long-term safety study of 12 months showed that the single tablet was well-tolerated.

This single tablet is currently under review with the United States Food and Drug Administration, under the proposed brand name Trexima(TM) (sumatriptan succinate/naproxen sodium).

Patient Satisfaction

An analysis of more than 2,800 migraine patients evaluated self-reported patient satisfaction.

  • Significantly more patients taking the single tablet were satisfied/very satisfied than compared to those taking placebo, sumatriptan formulated with RT Technology or naproxen sodium alone.
Workplace Productivity

Patients taking the single tablet had a significant reduction in mean total lost workplace productivity versus placebo, sumatriptan or naproxen sodium alone. Productivity was measured by completion of a productivity assessment evaluating lost productivity, activity time and total productivity loss.

Long-term Safety

A one-year study of 565 patients who treated nearly 24,500 migraine attacks (an average of five attacks per month) with the single tablet reported no new or unexpected adverse events. The most common treatment-related adverse events reported within 24 hours of taking the single tablet were nausea (6%), dizziness (3%), muscle tightness (3%), dyspepsia (2%) and paresthesia (2%).

Pozen, Inc. sponsored and GlaxoSmithKline supported these studies.

Other Data

Animal data presented by Rami Burstein, Ph.D., Associate Professor, Vice Chairman of Research, Department of Anesthesia and Critical Care, Beth Israel Deaconess Medical Center, Department of Neurobiology, Harvard Medical School, Boston, Mass., at the AAN meeting suggests that current migraine treatments alone do not address all of the components of migraine progression. Specifically, triptans cannot block the central neuronal sensitization that results from stimulation of the main sensory nerve (trigeminal nerve). In this study, investigators found that naproxen was effective at suppressing central neuronal sensitization. This study was funded by GlaxoSmithKline.

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 (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: www.gsk.com.

About POZEN

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, migraine or other pain related conditions. POZEN is also exploring the development of product candidates in other pain-related therapeutic areas. POZEN has 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: www.pozen.com.

SOURCE GlaxoSmithKline; Pozen, Inc.

CONTACT: Media, Robin Gaitens, +1-919-483-2839, or Analyst-Investor, Frank Murdolo, +1-215-751-7002, or Tom Curry, +1-215-751-5419, all of GSK US; or Investor, Bill Hodges, Chief Financial Officer, +1-919-913-1030, or Fran Barsky, Director, Investor Relations, +1-919-913-1044, or Media, Andrea Johnston, Pure Communications, 910-681-1088, all for POZEN, Inc.


Replication or redistribution of EDGAR Online, Inc. content is expressly prohibited without the prior written consent of EDGAR Online, Inc. EDGAR Online, Inc. shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.