Evaluation of a Novel Solubilized Formulation of Ibuprofen in the Treatment of Migraine Headache: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study

Abstract

A total of 729 migraine sufferers with moderate to severe baseline pain evaluated a single 200, 400 or 600 mg dose of a new liquigel formulation of ibuprofen over 8 h. Ibuprofen liquigels were significantly superior to placebo 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 response rates for ibuprofen 200, 400 and 600 mg and placebo were 64%, 72%, 72% and 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 mild or no limitation of activity (2-8 h). Ibuprofen liquigels were generally superior to placebo for reducing photophobia, phonophobia, or nausea (1-4 h) and for global evaluation. All doses were well tolerated. These data demonstrate that ibuprofen liquigels relieve the pain, ancillary symptoms, and limitation of activity, of migraine.