Treximet(TM) (Sumatriptan and Naproxen Sodium) Tablets Approved by FDA for Acute...

Treximet(TM) (Sumatriptan and Naproxen Sodium) Tablets Approved by FDA for
Acute Treatment of Migraine
Clinical studies show Treximet provided significantly more patients migraine
pain relief compared to sumatriptan 85 mg

LONDON, April 15 /PRNewswire-FirstCall/ -- GlaxoSmithKline (LSE: GSK)
(NYSE: GSK) and POZEN Inc. (Nasdaq: POZN) announced today that the FDA has
approved Treximet for the acute treatment of migraine attacks with or without
aura in adults. Treximet is the first and only migraine product designed to
target multiple mechanisms of migraine by combining a triptan, a class of
migraine-specific medicines pioneered by GSK, and an anti-inflammatory pain
reliever in a single tablet.
Treximet contains 85 mg sumatriptan, formulated with RT Technology(TM),
and 500 mg naproxen sodium. Sumatriptan is the active ingredient in Imitrex(R)
Tablets, available in 25 mg, 50 mg and 100 mg strengths. In clinical trials,
Treximet provided a significantly greater percentage of patients migraine pain
relief at two hours compared to sumatriptan 85 mg or naproxen sodium 500 mg
alone. In addition, Treximet provided more patients sustained migraine pain
relief from two to 24 hours compared to the individual components.
"Migraine patients want their medicine to work early, and to continue to
provide relief," said Dr. Stephen Silberstein, professor of neurology and
director of the Jefferson Headache Center at Thomas Jefferson University and
an investigator who participated in clinical trials. "The FDA approval of
Treximet is good news for migraine patients because clinical trials showed
that Treximet produced sustained migraine pain relief for a significant number
of patients." Further, Silberstein said, significantly fewer patients on
Treximet required the use of a rescue medication to treat their migraine
attack than those taking sumatriptan 85 mg.
Treximet is well studied, with more than 3,700 migraine sufferers treating
nearly 30,000 migraine attacks in clinical studies. The product is expected to
be available in U.S. pharmacies by mid-May.
Clinical Trials Demonstrated Superior Efficacy to Individual Components
The approval of Treximet was based on data from two identical
double-blind, randomized, placebo-controlled, parallel-group, multicenter
studies of more than 2,900 migraine sufferers.
Findings from these pivotal studies demonstrated that Treximet provided
more patients migraine pain relief at two and four hours compared to
sumatriptan 85 mg, naproxen sodium 500 mg or placebo alone. Importantly, in
these studies Treximet was effective at relieving the pain of a migraine
attack and maintaining that relief from two to 24 hours. In addition, Treximet
effectively relieved migraine associated symptoms -- nausea and sensitivity to
light and sound -- compared to placebo.
Treximet was generally well-tolerated in these pivotal studies. The most
common treatment-related adverse events reported within 24 hours of taking
Treximet were dizziness; nausea; somnolence; chest discomfort and chest pain;
neck, throat and jaw pain, tightness and pressure; numbness/tingling; upset
stomach; and dry mouth.
Treximet was also studied in a one-year open-label tolerability and safety
study of 565 patients who treated nearly 24,500 migraine attacks with the
active drug. Patients completing the one-year study treated an average of five
migraine attacks per month with Treximet.
Migraines Impact Millions of Americans
Migraine headaches continue to be a significant problem for the estimated
29.5 million Americans, nearly half of which are undiagnosed. According to the
International Headache Society's diagnostic criteria, migraine is
characterized by recurrent headaches which, if untreated, typically last four
to 72 hours, with symptoms including moderate to severe headache pain,
throbbing head pain, head pain located on one side of the head, head pain
aggravated by routine activity, nausea, vomiting, and sensitivity to light and
sound.
In the past, many clinicians believed that migraine was a vascular
condition, induced by blood vessel dilation alone. Today, new insight
suggests that migraine is much more complex, involving a chain of events that
are both neurovascular and inflammatory. Treximet contains sumatriptan that
mediates vasoconstriction, which correlates with the relief of migraine
headache. It also contains naproxen, an anti-inflammatory agent. Therefore,
sumatriptan and naproxen sodium contribute to the relief of migraine through
pharmacologically different mechanisms of action.
Important Safety Information About Treximet
Prescription Treximet is indicated for the acute treatment of migraine
attacks, with or without aura, in adults. Treximet should only be used where a
clear diagnosis of migraine headache has been established. Treximet may cause
an increased risk of serious cardiovascular thrombotic events, myocardial
infarction, and stroke, which can be fatal. This risk may increase with
duration of use. Patients with cardiovascular disease or risk factors for
cardiovascular disease may be at greater risk. Treximet contains a non-
steroidal anti-inflammatory drug (NSAID). NSAID-containing products cause an
increased risk of serious gastrointestinal adverse events including bleeding,
ulceration, and perforation of the stomach or intestines, which can be fatal.
These events can occur at any time during use and without warning symptoms.
Elderly patients are at greater risk for serious gastrointestinal events.
Treximet is contraindicated in patients with history, symptoms, or signs of
ischemic cardiac, cerebrovascular, or peripheral vascular syndromes and in
patients with other significant underlying cardiovascular diseases. Treximet
should not be given to patients in whom unrecognized coronary artery disease
is predicted by the presence of risk factors without a prior cardiovascular
evaluation. Treximet should not be given to patients with uncontrolled
hypertension because the components have been shown to increase blood
pressure. Concurrent administration of MAO-A inhibitors or use of Treximet
within two weeks of discontinuation of MAO-A inhibitor therapy is
contraindicated. Treximet and any ergotamine-containing or ergot-type
medication (like dihydroergotamine and mthysergide) should not be used within
24 hours of each other. Since Treximet contains sumatriptan, it should not be
administered with another 5-HT1 agonist. Treximet is contraindicated in
patients with hepatic impairment. Treximet is contraindicated in patients who
have had allergic reactions to products containing naproxen. It is also
contraindicated in patients in whom aspirin or other NSAIDs/analgesic drugs
induce the syndrome of asthma, rhinitis, and nasal polyps. Both types of
reactions have the potential of being fatal. Treximet is contraindicated in
patients with hypersensitivity to sumatriptan, naproxen, or any other
component of the product. Cerebrovascular events have been reported in
patients treated with sumatriptan. In a number of cases, it appears possible
that the cerebrovascular events were primary. It is important to advise
patients not to administer Treximet if a headache being experienced is
atypical. The development of a potentially life-threatening serotonin syndrome
may occur with triptans, including treatment with Treximet, particularly
during combined use with selective serotonin reuptake inhibitors (SSRIs) or
selective norepinephrine reuptake inhibitors (SNRIs). NSAID-containing
products, including Treximet, should be prescribed with extreme caution in
those with a prior history of ulcer disease or gastrointestinal bleeding.
Treximet should not be used in late pregnancy because NSAID-containing
products have been shown to cause premature closure of the ductus arteriosus.
Treximet should not be used during early pregnancy unless the potential
benefit justifies the potential risk to the fetus.
For complete Prescribing Information please visit
www.gsk.com .
About GlaxoSmithKline (LSE: GSK) (NYSE: GSK)
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:
www.gsk.com .
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation
Reform Act of 1995, GSK cautions investors that any forward-looking statements
or projections made by GSK, including those made in this announcement, are
subject to risks and uncertainties that may cause actual results to differ
materially from those projected. Factors that may affect GSK's operations are
described under 'Risk Factors' in the 'Business Review' in the company's
Annual Report on Form 20-F for 2007.
About POZEN (Nasdaq: POZN)
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 and other pain related
conditions. POZEN is also exploring the development of product candidates in
other pain-related therapeutic areas. POZEN has a development and
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 .
Safe Harbor Statement
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
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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
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SOURCE GlaxoSmithKline

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