Evaluation of a novel solubilized formulation of ibuprofen in the treatment of migraine headache: a randomized, double-blind, placebo-controlled, dose-ranging study

A total of 729 migraine sufferers with moderate to severe baseline pain eva luated a single 200, 400 or 600 mg dose of a new liquigel formulation of ib uprofen over 8 h. Ibuprofen liquigels were significantly superior to placeb o for cumulative headache response (pain reduced to mild or none) from 0.5 (600 mg) or 1 h (200 and 400 mg) to 8 h. At 2 h, respective headache respon se rates for ibuprofen 200, 400 and 600 mg and placebo were 64%, 72%, 72% a nd 50%. All three doses were also significantly superior to placebo for 2-h pain-free (25%, 28%, 29% and 13%, respectively) and for proportions with m ild or no limitation of activity (2-8 h). Ibuprofen liquigels were generall y superior to placebo for reducing photophobia, phonophobia, or nausea (1-4 h) and for global evaluation. All doses were well tolerated. These data de monstrate that ibuprofen liquigels relieve the pain, ancillary symptoms, an d limitation of activity, of migraine.