AbbVie Inc UBRELVY Results Published in The Lancet
AbbVie Inc (ABBV) 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.
What Is the Prodrome
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. 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.
Dawn Carlson, vice president, neuroscience development, AbbVie said, “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. “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.” He added, “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. These new data speak directly to a gap in migraine treatment and the option to use ubrogepant.”
During the trial, patients with migraine who could identify prodromal symptoms that led to headache at least 75% of the time, 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.
- Absence of moderate or severe intensity headache within 48 hours was achieved following 41% of qualifying prodrome events when treated with UBRELVY vs. 25% of placebo-treated event
- More patients had normal function within the 24 hours after treatment of qualifying prodrome events with UBRELVY than after placebo [Odds Ratio (OR) 1.66, 95% Confidence Interval (CI) 1∙40–1∙96.
- Absence of headache of any intensity within 24 hours was achieved following 24% of qualifying prodrome events when treated with UBRELVY vs. 14% of placebo-treated events.
- The safety population included 480 patients, and the efficacy analysis population included 477 patients.The most commonly reported prodrome 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 administered during the prodrome.The most common side effects are nausea (UBRELVY: 5% vs. placebo: 3%), fatigue (UBRELVY: 3% vs. placebo: 2%), dizziness (UBRELVY: 2% vs. placebo: 3%), and somnolence (UBRELVY: 2% vs. placebo: 1%).
PRODROME (NCT04492020) was a Phase 3, multicenter, randomized, double-blind, placebo-controlled, crossover trial that enrolled adults who experienced 2-8 migraine attacks with moderate-to-severe headache per month. Eligible patients treated 2 “qualifying prodrome events” in a crossover fashion. A qualifying prodrome event was defined as a migraine attack with prodromal symptoms in which the patient was confident a headache would follow within 1-6 hours. The primary endpoint was absence of moderate/severe intensity headache within 24 hours post-dose. Secondary endpoints were absence of moderate/severe intensity headache within 48 hours, ability to function normally over 24 hours, and absence of a headache of any intensity within 24 hours post-dose. Patients used an e-diary to record the presence and severity of symptoms at the time of each qualifying prodrome event.
What is UBRELVY® (ubrogepant)?
UBRELVY is a prescription medicine used for the acute treatment of migraine attacks with or without aura in adults. UBRELVY is not used for migraine prevention. UBRELVY® is orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the acute treatment of migraine with or without aura in adults that is an option for a wide range of patients who experience migraine attacks. UBRELVY® is the first pill of its kind designed to directly block CGRP, a protein released during a migraine attack, from binding to its receptors.
Migraine is a complex neurological disease with recurrent attacks that are often incapacitating and is characterized by severe, throbbing headache pain as well as compounding associated symptoms like extreme sensitivity to light, sound or nausea. It is highly prevalent, affecting more than 1 billion people worldwide, including nearly 40 million people in the United States alone, and is the highest cause of disability worldwide for people under 50 years of age.
About AbbVie Inc in Neuroscience:
At AbbVie, our commitment to preserve the personhood of those living with neurological and psychiatric disorders is unwavering. Every challenge in this uncharted territory makes us more determined and drives us harder to discover and deliver solutions for patients, care partners and clinicians. AbbVie’s Neuroscience portfolio consists of approved therapies in neurological and psychiatric disorders, including bipolar I disorder, cervical dystonia, major depressive disorder, migraine, Parkinson’s disease, post-stroke spasticity, schizophrenia and others, along with a robust pipeline.
We have a strong investment in neuroscience research, with our Foundational Neuroscience Center in Cambridge, Massachusetts, and our Neuroscience Discovery site in Ludwigshafen, Germany, where our research and resilience in these challenging therapeutic areas is yielding a deeper understanding of the pathophysiology of neurological and psychiatric disorders, and identifying targets for potential disease-modifying therapeutics aimed at making a difference in people’s lives.
AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com.
We believe it’s important that the people who are suffering from various kinds of devastating migraines be in contact with AbbVie, the only company that has three prescription treatments designed to meet patient needs across the full spectrum of migraine. It, indeed, helps the patients living with this debilitating disease and educates them through its advancing science and enables healthcare providers to care for people impacted across the spectrum of migraine. Through education and partnerships with the migraine community, AbbVie strive to help those with migraine reach effective treatments and reduce the impact of the devastating migraine on their lives.
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