Single Tablet Designed to Target Multiple Mechanisms of Migraine
SAN DIEGO, April 5 /PRNewswire-FirstCall/ -- A single tablet containing
sumatriptan 85 mg as the succinate salt, formulated with RT Technology, and
naproxen sodium 500 mg showed superior results in treating acute migraine pain
compared to use of sumatriptan alone or placebo, according to new data
presented today at the 58th Annual Meeting of the American Academy of
Neurology (AAN) in San Diego. Findings from two identical studies including
more than 2,800 migraine sufferers 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.
"We now have a better understanding of how a migraine develops in the
brain, enabling us to develop new therapies that target multiple mechanisms,"
said Dr. Stephen Silberstein, professor of neurology and director of the
Jefferson Headache Center at Thomas Jefferson University. "Current treatments
do not address all of the mechanisms of migraine that produce symptoms. The
product evaluated in these studies is designed to target multiple mechanisms
About the Studies
The studies evaluated the efficacy and tolerability of an acute migraine
treatment currently under review by the United States Food and Drug
Administration 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:
Multiple Mechanisms of Migraine
- The compound was more effective than either sumatriptan 85 mg
formulated with RT Technology alone or placebo for pain relief at two
hours in study 1 (57%, 50%, 29% respectively) and also in study 2 (65%,
55%, 28% respectively).
- The compound was more effective than either sumatriptan 85 mg
formulated with RT Technology alone or placebo for pain relief at four
hours in study 1 (72%, 61%, 37% respectively) and in study 2 (78%, 66%,
- In comparisons with placebo, the compound resulted in lower rates of
associated symptoms of migraine - photophobia, phonophobia and nausea -
at two hours after dosing. 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.
- The most commonly reported adverse events with the compound were
dizziness (4%), somnolence (3%), nausea (3%), tingling (2%), dyspepsia
(2%), dry mouth (2%) and chest discomfort (2%).
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.
"Medications like triptans treat migraines by preventing the release of
inflammatory substances and pain transmitting signals, but they do not address
initial inflammation, which is essentially where the migraine begins," said
Dr. Silberstein. "A therapy that both inhibits inflammation and treats pain
may address multiple mechanisms of migraine."
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 and 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.
Pozen, Inc. sponsored and GlaxoSmithKline supported these studies.
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.