New Data Show Investigational Migraine Therapy Demonstrates Effective Treatment of Migraine-Associated Neck and Sinus Pain

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significantly more patients reached pain-free
status at two hours; this result was sustained for 24 hours without the use
of additional medicine. This single tablet combination therapy -- currently
under review with the U.S. Food and Drug Administration (FDA) under the
proposed trade name Trexima(TM) -- contains sumatriptan 85 mg, as the
succinate salt, formulated with RT Technology(TM), and naproxen sodium 500
mg.
    "These data suggest that a single treatment designed to target multiple
mechanisms of migraine may be an effective option for many patients," said
Stephen Silberstein, MD, director of the Jefferson Headache Center and lead
study investigator. "In particular, we're excited because these studies
show promise at treating associated symptoms of migraine such as neck pain
and discomfort and sinus pain and pressure, which can be difficult to
alleviate."
    Recent data indicate 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. 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.
    About the Studies
    The studies evaluated the efficacy and tolerability of sumatriptan
85mg, formulated with RT Technology(TM), and naproxen sodium 500 mg versus
placebo for the treatment of mild migraine pain. The data were derived from
two identical randomized, multi-center, double-blind, placebo-controlled
parallel group, single attack (treating mild pain within one hour of onset)
trials of adult migraineurs in the U.S. Study results indicated:
    --  Neck pain and discomfort decreased significantly at two hours for the
        compound versus placebo in study 1 (35 and 44 percent) and study 2
        (28 and 54 percent).
    --  Sinus pain and pressure decreased significantly at two hours for the
        compound versus placebo in study 1 (19 and 33 percent) and study 2
        (23 and 38 percent).(1)
    --  More patients were pain free at two hours in both studies (52 and
        51 percent) compared to placebo (17 and 15 percent) and sustained
        pain-free response was maintained for significantly more patients
        (45 and 40 percent), without the use of a rescue medication, to
        24 hours, compared to placebo (12 and 14 percent).
    --  The compound was effective in rapidly eliminating migraine pain, as
        measured by pain-free rates at 30 minutes, one hour, two hours and
        four hours.
    --  Incidence of migraine associated symptoms (nausea, phonophobia
        (sensitivity to sound) and photophobia (sensitivity to light)) was
        lower with the compound than with placebo.
    --  The compound was generally well-tolerated.  In both studies, only
        nausea (3 and 4 percent) and dizziness (1 and 2 percent) were reported
        in at least 2 percent of patients who took the compound versus placebo
        (1 and 2 percent for nausea, 0 and < 1 percent for dizziness).
    "This data illustrates how the new understanding of migraine
pathophysiology is leading to the development of effective treatments with
an early and sustained effect," continued Dr. Silberstein.
    Multiple Mechanisms of Migraine
    Understanding the multiple mechanisms of migraine may 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.
    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: http://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 and
other pain related conditions. 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 .
    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 current expectations and are subject to a number of risks and
uncertainties, 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 additional studies, or the failure to obtain such approval
of our product candidates, including as a result of changes in regulatory
standards or the regulatory environment during the development period of
any of our product candidates; uncertainties in clinical trial results or
the timing of such trials, resulting in, among other things, an extension
in the period over which we recognize deferred revenue or our failure to
achieve milestones that would have provided us with revenue; our inability
to maintain or enter into, and the risks resulting from our dependence
upon, collaboration or contractual arrangements necessary for the
development, manufacture, commercialization, marketing, sales and
distribution of any products; competitive factors; our inability to protect
our patents or proprietary rights and obtain necessary rights to third
party patents and intellectual property to operate our business; our
inability to operate our business without infringing the patents and
proprietary rights of others; general economic conditions; the failure of
any products to gain market acceptance; our inability to obtain any
additional required financing; technological changes; government
regulation; changes in industry practice; and one-time events, including
those discussed herein and in our Quarterly Report on Form 10-Q for the
period ended March 31, 2006. We do not intend to update any of these
factors or to publicly announce the results of any revisions to these
forward-looking statements.
    POZEN Inc. sponsored and GlaxoSmithKline supported these studies.

Taken from PR Newswire

MedicineNet Migraine General
MedicineNet Migraine General

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