AbbVie said its oral migraine medicine atogepant met the primary endpoint and all eight ranked secondary endpoints in a Phase3 study evaluating prevention of menstrual migraine in adults.
The LUNA trial enrolled 468 adult women with pure menstrual migraine or menstrually related migraine, with or without aura, at sites in Europe and Asia. It was a multicenter, randomized, double-blind, placebo-controlled study with an open-label extension.
Participants took atogepant for seven consecutive days, beginning three days before the expected onset of menstruation, over three menstrual cycles. The drug is a calcitonin gene-related peptide, or CGRP, receptor antagonist.
The primary endpoint measured change from baseline in the number of migraine days during the perimenstrual period, averaged across the three menstrual cycles in the double-blind portion of the trial.
Patients treated with atogepant had an average reduction of 1.20 perimenstrual migraine days, compared with a 0.40-day reduction among placebo recipients. That represented 0.80 fewer migraine days versus placebo, a statistically significant difference with a reported p-value of less than 0.0001.
Atogepant also showed statistically significant differences from placebo across measures that included headache burden, acute medication use, functional disability, cognitive function and responder outcomes, AbbVie said. The company did not provide numerical results for the secondary endpoints in its announcement.
Safety findings were consistent with atogepant’s previously known profile, and the company said no new safety signals were observed.
Atogepant is marketed as Qulipta in the United States, Canada, Israel and Puerto Rico, and as Aquipta in the European Union. It is approved for preventive migraine treatment in adults but is not specifically approved for menstrual migraine.
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