Phase 3 Study for AbbVie’s Ubrelvy Reports Promising Results

AbbVie announced 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. According to a Phase 3 prodrome study, results indicated that the medication significantly reduced the likelihood of development of moderate or severe headache, and reduced functional disability compared to placebo within 24 hours post-dose.¹

“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, VP, neuroscience development, AbbVie, in a company press release. “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.”

First approved in December 2019 as a new drug application for the acute treatment of migraine with or without aura in adults by Allergan, Ubrelvy was acquired along with Allergan by AbbVie in the same year for $63 billion.^2,3

In the trial, patients able to identify prodromal symptoms leading to headaches were assigned to double-blind crossover treatment. Results showed that Ubrelvy led to a 46% absence of moderate or severe headaches within 24 hours compared to 29% with a placebo. Similar positive outcomes were observed at 48 hours and included improved overall function.¹

“As a neurologist, I have many patients who can describe the premonitory, or prodrome, symptoms of their migraine attacks, and previously, we have not had adequate data for treatment options during this earliest phase,” said Peter J. Goadsby, MD, PhD, FRS, neurologist and professor at King’s College London. “These new data speak directly to a gap in migraine treatment and the option to use ubrogepant.”

References

1. Results Published in The Lancet Show UBRELVY® (ubrogepant) Reduces the Headache Phase of a Migraine Attack When Dosed During the Prodrome of Migraine. AbbVie. November 16, 2023. Accessed November 20, 2023. https://news.abbvie.com/2023-11-16-Results-Published-in-The-Lancet-Show-UBRELVY-R-ubrogepant-Reduces-the-Headache-Phase-of-a-Migraine-Attack-When-Dosed-During-the-Prodrome-of-Migraine

2. AbbVie’s Migraine Drug Ubrelvy Scores Victory in Phase III Study. BioSpace. November 17, 2023. Accessed November 20, 2023. https://www.biospace.com/article/abbvie-s-migraine-drug-ubrelvy-scores-victory-in-phase-iii-study-/

3. Allergan Receives U.S. FDA Approval for UBRELVY™ for the Acute Treatment of Migraine with or without Aura in Adults. BioSpace. December 23, 2023. Accessed November 20, 2023. https://www.biospace.com/article/releases/allergan-receives-u-s-fda-approval-for-ubrelvy-for-the-acute-treatment-of-migraine-with-or-without-aura-in-adults/?keywords=%22ubrelvy%22