Trexima Provided Relief Of Both Traditional And Non-traditional Migraine Symptoms

Migraine Symptoms

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.

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.

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.