AbbVie’s Migraine Drug Ubrelvy Scores Victory in Phase III Study
Pictured: AbbVie's office in California/iStock, Michael Vi
Data from the Phase III PRODROME study showed that AbbVie’s migraine drug Ubrelvy (ubrogepant), when given ahead of an expected episode, safely and effectively reduces the likelihood of developing moderate or severe headache, the company reported Thursday.
When given during the prodrome phase—around one to six hours before an anticipated attack—Ubrelvy led to the absence of moderate or severe headaches within 24 hours of treatment in 46% of qualifying prodrome events. In comparison, only 29% of qualifying prodrome events were free of such headaches in the placebo group.
This effect was highly statistically significant, with p-value less than 0.0001, according to AbbVie’s announcement.
In addition, more patients in the Ubrelvy arm achieved normal function within 24 hours of treatment versus placebo. During this observation window, the absence of headaches of any intensity was likewise higher in patients treated with AbbVie’s migraine drug, as compared with placebo.
In terms of safety, the PRODROME trial found Ubrelvy to be safe with no new signals of concern. The most common side effects were nausea, fatigue, dizziness and somnolence.
The results were also published in the medical journal The Lancet.
Patients who are able to spot their prodromal symptoms are given an “opportunity to stop migraine attacks before they become fully debilitating,” Dawn Carlson, vice president of neuroscience at AbbVie, said in a statement.
These new data from PRODROME highlight such preventive benefits of Ubrelvy and “demonstrate the important role of Ubrelvy in treating migraine attacks early and reducing the overall burden of a migraine attack,” Carlson said.
Ubrelvy is an oral small molecule drug that binds and inhibits the CGRP receptor, which is commonly expressed in primary sensory neurons and is typically elevated during migraine attacks. The drug won the FDA’s approval in December 2019 for the acute treatment of migraine with or without aura in adults. In the U.S., Ubrelvy is the first oral pill designed to block CGRP.
AbbVie became a leader in the migraine space after it acquired Allergan in 2019 for $63 billion—a deal that secured it rights over Ubrelvy. In 2021, AbbVie deepened its migraine franchise with an FDA approval for Qulipta (atogepant), another oral CGRP receptor antagonist, for the treatment of episodic migraine headaches.
In April 2013, AbbVie successfully expanded Qulipta’s label to include chronic migraine, making the drug the only oral CGRP receptor blocker indicated for both episodic and chronic migraine.