Results Published in The Lancet Show UBRELVY® (ubrogepant) Reduces the Headache Phase of a Migraine Attack When Dosed During the Prodrome of Migraine

Published

-     More patients treated with UBRELVY® 100 mg during the prodrome avoided the development of moderate or severe headache within 24 hours post-dose vs. placebo in those who could identify prodrome symptoms that were reliably followed by headache 1-     UBRELVY is the first and only acute treatment for migraine that has demonstrated data in the prodrome phase in a Phase 3, double-blind, placebo-controlled trial-     AbbVie is the only company with three prescription treatments designed to meet patient needs across the full spectrum of migraine

NORTH CHICAGO, Ill., Nov. 16, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced detailed results published in The Lancet evaluating the efficacy, safety, and tolerability of UBRELVY® (ubrogepant) 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 (i.e., 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.1

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.2,3 In people with migraine who experience a prodrome, symptoms can occur hours to days before the onset of headache. Treatment during the prodrome provides an opportunity to avoid the development or attenuate the severity of the headache phase of a migraine attack.4,5

"Migraine impacts nearly 40 million Americans and is a highly debilitating disease that can cause people to miss work, and time with friends and family. 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," said Dawn Carlson, vice president, neuroscience development, AbbVie. "These data published in The Lancet demonstrate the important role of UBRELVY in treating migraine attacks early and reducing the overall burden of a migraine attack."

During the trial, patients with migraine who could identify prodromal symptoms that led to headache at least 75% of the time (N=518), were randomly assigned to double-blind crossover treatment. Study results demonstrated the following:

  • 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 (P

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