While many migraine sufferers experience
traditional symptoms such as nausea or sensitivity to light and sound,
migraine attacks can also involve symptoms like neck pain or sinus pain
that are not traditionally associated with migraine headaches. New data
show that significantly more patients using the investigational migraine
treatment Trexima early in their migraine attacks were pain free at two
hours and experienced relief from both traditional and non-traditional
symptoms, compared to patients taking placebo. These data were presented
today at the 59th Annual Meeting of the American Academy of Neurology.
In these studies, more than 1,100 patients treated more than 3,300
migraine attacks. At the beginning of the studies, many patients
experienced traditional migraine symptoms: nausea (27-33 percent),
sensitivity to light (69-74 percent) and sensitivity to sound (62-69
percent). Additionally, many patients also reported the non-traditional
migraine-associated symptoms of sinus pain/pressure (39-44 percent) or neck
pain/discomfort (59-61 percent).
"One of the challenges in migraine treatment is helping patients get
relief for the specific symptoms associated with each attack," said Robert
Kaniecki, MD, director of the Headache Center at the University of
Pittsburgh. "These data are important because for the first time we have
evidence of efficacy in treating both traditional and non-traditional
migraine-associated symptoms across multiple migraine attacks."
Trexima, the proposed brand name for a single tablet containing
sumatriptan 85 mg formulated with RT Technology(TM) and naproxen sodium 500
mg, is currently under review by the US Food and Drug Administration for
the acute treatment of migraines in adults.
Understanding the Multiple Mechanisms of Migraine
Migraine pain is believed to be induced not only by the widening of the
blood vessels, or vasodilation, but also involves neurochemical release and
prostaglandin production. These mechanisms lead to inflammation, resulting
in increased pain perception and sensitization of nerves. Understanding the
multiple mechanisms of migraine may also explain why migraine sufferers
often experience a variety of non-traditional migraine symptoms in addition
to head pain, nausea or vomiting, and sensitivity to light and sound.
Stimulation of the main sensory nerve may cause referral of pain to any of
the nerve's three branches, resulting in sinus or facial pain; it may also
cause referral of pain to the sensory nerves of the posterior head and
neck, resulting in neck pain.
Relief from Non-Traditional and Traditional Migraine Symptoms
The data are from two identical multi-center, double-blind, placebo-
controlled cross-over studies of adult migraine sufferers. The study
incorporated an early intervention model, in which patients were instructed
to treat while migraine pain was mild and within one hour of onset.
Endpoints included post-treatment incidence of traditional symptoms,
defined as nausea, vomiting, photophobia (sensitivity to light) and
phonophobia (sensitivity to noise); and non-traditional symptoms, defined
as sinus pain/pressure and neck pain/discomfort. Response to these symptoms
was measured at two and four hours. This is the first study to evaluate
traditional and non-traditional migraine-associated symptoms in a
controlled early intervention setting across multiple attacks.
In both studies, patients taking Trexima reported a significantly lower
incidence of traditional and non-traditional migraine-associated symptoms
compared to placebo at two and at four hours.
-- The approximate difference between Trexima and placebo at two hours for
each symptom was as follows: nausea (6 percent), sensitivity to light
(22 percent), sensitivity to sound (18 percent), sinus pain/pressure
(14 percent) and neck pain/discomfort (10 percent).
-- The approximate difference between Trexima and placebo at four hours
for each symptom was as follows: nausea (12 percent), sensitivity to
light (26 percent), sensitivity to sound (24 percent), sinus
pain/pressure (16 percent) and neck pain/discomfort (16 percent).
In more than 1,100 patients treating more than 3,300 attacks, adverse
events reported in at least 2 percent of patients within 72 hours of taking
Trexima were nausea, dizziness, dry mouth, somnolence and fatigue.
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 smoking, 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 with asthma and nasal polyps in whom aspirin or
other NSAIDs induce an exacerbation of asthma. 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 -- 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:
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About POZEN
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 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: pozen.
Pozen Inc. sponsored and GlaxoSmithKline supported these studies.
GlaxoSmithKline
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View drug information on Imitrex.