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Trexima (Sumatriptan/Naproxen Sodium) Provided Relief of Both,Traditional and Non-traditional Migraine Symptoms

eved 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 soun
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