More participants reported pain freedom at two hours with 50-mg, 25-mg ubrogepant versus placebo
TUESDAY, Nov. 19, 2019 (HealthDay News) — Acute treatment of migraine with ubrogepant leads to significantly greater rates of pain freedom at two hours than placebo, according to a study published online Nov. 19 in the Journal of the American Medical Association.
Richard B. Lipton, M.D., from the Albert Einstein College of Medicine in Bronx, New York, and colleagues conducted a phase 3 multicenter trial involving adults with migraine with or without aura experiencing two to eight migraine attacks per month. Participants were randomly assigned to either ubrogepant 50 mg (562 participants), ubrogepant 25 mg (561 participants), or placebo (563 participants) for a migraine attack of moderate or severe pain intensity.
The researchers found that pain freedom at two hours was reported by 21.8, 20.7, and 14.3 percent of participants in the ubrogepant 50-mg, ubrogepant 25-mg, and placebo groups, respectively (absolute difference for 50 mg versus placebo, 7.5 percent [95 percent confidence interval (CI), 2.6 to 12.5 percent; P = 0.01]; absolute difference for 25 mg versus placebo, 6.4 percent [95 percent CI, 1.5 to 11.5 percent; P = 0.03]). Absence of the most bothersome associated symptom at two hours was reported by 38.9, 34.1, and 27.4 percent of participants in the ubrogepant 50-mg, ubrogepant 25-mg, and placebo groups, respectively (absolute difference for 50 mg versus placebo, 11.5 percent [95 percent CI, 5.4 to 17.5 percent; P = 0.01]; absolute difference for 25 mg versus placebo, 6.7 percent [95 percent CI, 0.6 to 12.7 percent; P = 0.07]).
“Further research is needed to assess the effectiveness of ubrogepant against other acute treatments for migraine and to evaluate the long-term safety of ubrogepant among unselected patient populations,” the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Allergan, which manufactures ubrogepant and funded the study.
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