Despite competing against several drugs that have been approved to fend off migraine headaches, AbbVie’s Ubrelvy (ubrogepant) —which is approved only to treat them—has carved out a significant niche in the crowded migraine market.
Recent trial results, however, indicate that Ubrelvy holds the potential to prevent migraines when used in reaction to their warning signs. In a study published this week in the journal Neurology, Ubrelvy was 73% more effective in preventing a migraine attack than a placebo.
In the phase 3 PRODROME trial, 518 patients who have had 2 to 8 migraine headaches per month for at least a year were instructed to take their medicine after receiving warning signals that an attack was on its way. The symptoms in the prodrome (initial) stage of migraine include fatigue, dizziness, visual aura, neck pain and sensitivity to light and sound.
In the first round of treatment—which included two migraine episodes over a period of two months—patients received a 100 mg dose of Ubrelvy or placebo. In a second round of testing, patients were provided with the treatment that they did not receive in the initial round.
After 24 hours, 65% of those who received Ubrelvy reported that they were either “not at all limited” or were “a little limited,” compared to 48% of placebo recipients who reported the same. Additionally, within two hours of dosing, patients who had taken Ubrelvy were 73% more likely to report “no disability, able to function,” than those on placebo.
“Based on our findings, treatment with ubrogepant may allow people with migraine who experience early warning signs before a migraine occurs to quickly treat migraine attacks in their earliest stages and go about their daily lives with little discomfort and disruption,” Richard Lipton, M.D., vice chair of neurology at the Albert Einstein College of Medicine in Bronx, N.Y., said in a news release.
The results combine with similar findings from the PRODROME trial which were published in The Lancet in November of last year. Those showed an absence of moderate or severe headache within 24 hours of taking a dose in 46% of those who took ubrogepant compared to 29% of those who received a placebo.
Ubrelvy, which was approved in 2019 and achieved sales of $815 million in 2023, is one of several calcitonin gene-related peptide receptor (CGRP) antagonists on the market for migraine headaches. Another is AbbVie’s Qulipta, which was approved as a preventative in 2021 and racked up sales of $408 million last year.
The top-selling CGRP is Pfizer’s Nurtec, which rang up sales of $928 million last year. It was approved in 2020 and was endorsed for preventative use in 2021.
Three other CGRPs—all approved in 2018 for the prevention of migraines—remain formidable. Eli Lilly’s Emgality generated $678 million in sales last year, while Teva’s Ajovy pulled in $435 million and Amgen’s Aimovig collected $303 million.