AbbVie’s Ubrelvy shows efficacy in migraine in The Lancet-published study

AbbVie announced detailed results published in The Lancet evaluating the efficacy, safety, and tolerability of Ubrelvy 100 mg for the acute treatment of migraine when administered during the prodrome of a migraine attack. The Phase 3 study, PRODROME, showed that Ubrelvy given during the prodrome – 1-6 hours before the predicted onset of headache pain – significantly reduced the likelihood of development of moderate or severe headache and reduced functional disability compared to placebo within 24 hours post-dose. The prodrome is the earliest of four phases of a migraine attack and consists of various symptoms, including sensitivity to light and/or sound, fatigue, and neck pain, that can be an early sign that the headache phase will follow. Study results demonstrated: absence of moderate or severe intensity headache within 24 hours was achieved following 46% of qualifying prodrome events when treated with Ubrelvy vs. 29% of placebo-treated events; absence of moderate or severe intensity headache within 48 hours was achieved following 41% of qualifying prodrome events when treated with Ubrelvy vs. 25% of placebo-treated events; more patients had normal function within the 24 hours after treatment of qualifying prodrome events with Ubrelvy than after treatment with placebo; absence of headache of any intensity within 24 hours was achieved following 24% of qualifying prodrome events when treated with Ubrelvy vs. 14% of placebo-treated events. The safety population included 480 patients, and the efficacy analysis population included 477 patients. The most commonly reported prodrome symptoms in the study were sensitivity to light, fatigue, neck pain, sensitivity to sound and dizziness/lightheadedness. Ubrelvy was well-tolerated with no new safety signals observed when administered during the prodrome.