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news.GlaxoSmithKline has reported that treatment with Treximet provided sustained pain-free results at two through 24 hours and was generally well-tolerated in two studies of migraineurs who had poor response to, or did not tolerate, short-acting triptans.
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The data are from two identical randomized multi-center, double-blind, placebo-controlled crossover trials that evaluated 283 men and women who typically had a history of four to five migraines each month. Subjects were randomized to receive Treximet or placebo and were instructed to treat within an hour of onset of the migraine while the headache pain was still mild.
In both studies – Treximet was superior to placebo in producing sustained pain-free results from two through 24 hours (26% versus eight percent in Study one; and 31% versus eight percent in Study two). At two hours, four in 10 subjects taking Treximet were pain-free as compared to fewer than two in 10 subjects taking placebo.
The majority of subjects taking Treximet were pain-free at eight hours (65%in Study one; 66% in Study two). Fewer than three in 10 subjects taking Treximet reported the need for a rescue medication as compared to approximately six in 10 subjects taking placebo.
Each study demonstrated that, as compared to placebo, Treximet provided sustained relief at two through 24 hours of traditional migraine-associated symptoms including nausea and sensitivity to light and sound, as well as non-traditional migraine-associated symptoms including sinus and neck pain. In addition, subjects taking Treximet reported higher medication satisfaction, as compared to placebo and the triptans used prior to the study.