AbbVie's Ubrelvy significantly cuts headache pain if taken during prodrome

16 Nov 2023
firstwordpharma.com
Phase 3Clinical ResultDrug Approval
AbbVie said Thursday that significantly more migraine patients in a Phase III study who took its oral CGRP receptor antagonist Ubrelvy (ubrogepant) in the hours before the predicted onset of headache pain, avoided experiencing moderate-to-severe headache in the 24 hours that followed, compared to placebo. "These data… demonstrate the important role of Ubrelvy in treating migraine attacks early and reducing the overall burden of a migraine attack," remarked Dawn Carlson, the company's head of neuroscience development.
The drug, which was approved in the US in 2019, is indicated for the acute treatment of migraine with or without aura in adults. AbbVie said Ubrelvy sales were up close to 46% during the third quarter, reaching $233 million.
The Phase III PRODROME study included 518 adult participants who experienced 2 to 8 migraine attacks with moderate-to-severe headache per month. Eligible patients treated two qualifying prodrome events in a crossover fashion. A qualifying prodrome event was defined as a migraine attack with prodromal symptoms in which the patient was confident that a headache would ensue within 1 to 6 hours. The most commonly reported prodrome symptoms in the study were sensitivity to light, fatigue, neck pain, sensitivity to sound and dizziness/lightheadedness.
Stopping migraine attacks early
The primary endpoint was absence of moderate-to-severe intensity headache within 24 hours post-dose. Findings, which was published in The Lancet, showed that the absence of moderate or severe intensity headache within 24 hours was achieved following 46% of qualifying prodrome events when treated with Ubrelvy, versus 29% of placebo-treated events. At 48 hours, the rates were 41% and 25%, respectively. In addition, more patients had normal function within the 24 hours after treatment of qualifying prodrome events with Ubrelvy, than they did if they took placebo.
"For patients who are able to identify prodromal symptoms, the ability to treat a migraine attack before the headache phase creates an opportunity to stop migraine attacks before they become fully debilitating," Carlson said. Meanwhile, AbbVie reported that Ubrelvy was well-tolerated with no new safety signals observed when administered during the prodrome phase. The most common side effects were nausea, fatigue, dizziness and somnolence.
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