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).
An analysis of more than 2,800 migraine patients evaluated self-reported
- 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.
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
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.
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
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:
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.