Trexima Demonstrated Migraine-Free Response Across Multiple Attacks
Trexima, when taken early, was nearly twice as effective as placebo in eliminating all traditional migraine symptoms at two and four hours across multiple attacks with just one tablet.
The findings will be presented tomorrow at the 49th Annual Scientific Meeting of the American Headache Society.
In addition to head pain, migraine attacks often include nausea, vomiting and sensitivity to light or sound, making it difficult for sufferers to participate in daily activities. Most migraine studies focus on pain relief or pain-freedom, which only assesses head pain. This is one of the few studies to measure migraine-free response across multiple attacks, which is significant because it means that the associated symptoms of migraine, as well as the head pain, are gone.
"I believe this key endpoint will have more meaning to patients, as it measures when the whole migraine is gone rather than just the head pain," said Dr. Paul Winner, lead author and director of the Palm Beach Headache Center. "In these studies we found Trexima consistently eliminated migraine symptoms in more patients without the need for rescue medication."
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 FDA for the acute treatment of migraines in adults.
The data are from two identical multi-center, double-blind, placebo- controlled cross-over studies of adult migraine sufferers. Migraine-freeresponse is defined as freedom from migraine pain, nausea, vomiting, sensitivity to light and sound, and without the use of rescue medication at or before the time points specified. Subjects were randomized to one of five sequence groups and instructed to treat four migraine attacks. Patients in four groups received Trexima in three of four attacks and placebo in the remaining attack. Patients in the fifth group received Trexima for all four attacks.
In each study, approximately 40 percent of patients taking Trexima were migraine-free at two hours, compared to about 20 percent on placebo. At four hours, about two-thirds of patients taking Trexima were migraine-free, compared to about one-third of those on placebo.
In more than 1,100 patients treating more than 3,300 attacks, the overall adverse event rate, corrected for attack, was 9 percent and 7 percent in Study 1 and 13 percent and 9 percent in Study 2, for Trexima and placebo, respectively. Adverse events reported in at least 2 percent of patients within 72 hours of taking Trexima were nausea, dizziness, dry mouth, somnolence and fatigue.