Oral CGRP Receptor Antagonist Ubrelvy (ubrogepant) Significantly Reduces Migraine Attacks Within Hours: Phase 3 PRODROME Trial Published in The Lancet

▎Edited by the WuXi AppTec content team

Recently, AbbVie announced detailed results from the Phase 3 clinical trial PRODROME evaluating the efficacy, safety, and tolerability of 100 mg Ubrelvy (ubrogepant) for the acute treatment of migraine during the prodromal phase on The Lancet, a top-tier global medical journal. Compared with placebo,Taking Ubrelvy during the premonitory phase of a migraine attack (i.e., 1-6 hours before the anticipated headache) can significantly reduce the likelihood of moderate or severe headaches and decrease functional disability within 24 hours after taking the medication.

During the trial, at least 75% of migraine patients (518 individuals) experienced prodromal symptoms that could lead to headaches. These patients were randomly assigned to receive double-blind crossover treatment. The study results are as follows:

Among patients treated with Ubrelvy, 46% did not experience moderate or severe headache within 24 hours, compared to 29% of those treated with placebo (P

Among patients treated with Ubrelvy, 41% did not experience moderate or severe headaches within 48 hours, compared to 25% of those treated with placebo (P

Compared with the use of placebo, more patients returned to normal function within 24 hours after using Ubrelvy to treat prodromal symptoms.

Image Source: WuXi AppTec Content Team

After receiving Ubrelvy treatment,24% of patients with prodromal symptoms did not experience any degree of headache within 24 hours, compared to only 14% of patients receiving placebo who did not experience any degree of headache within the same timeframe (P

The safety analysis of the trial included 480 patients, and the efficacy analysis population included 477 patients. The most commonly reported prodromal symptoms in the study were sensitivity to light, fatigue, neck pain, sensitivity to sound, and dizziness/lightheadedness.Ubrelvy was well tolerated, with no new safety signals observed when used during the prodromal phase.The most common side effects are nausea (Ubrelvy: 5%, placebo: 3%), fatigue (Ubrelvy: 3%, placebo: 2%), dizziness (Ubrelvy: 2%, placebo: 3%), and somnolence (Ubrelvy: 2%, placebo: 1%).

Ubrelvy is an orally administered calcitonin gene-related peptide (CGRP) receptor antagonist, used for the acute treatment of migraine with or without aura in adults. In 2019, the U.S. FDA approved Ubrelvy's new drug application for the acute treatment of migraine. The press release noted,Ubrelvy is the first oral CGRP receptor antagonist for the treatment of migraine, representing a new class of drugs for this stubborn disease.。