Results Published in The Lancet Show UBRELVY® (ubrogepant) Reduces the Headache Phase of a Migraine Attack When Dosed During the Prodrome of Migraine

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Nov 16, 2023, 07:00 ET

- More patients treated with UBRELVY^® 100 mg during the prodrome avoided the development of moderate or severe headache within 24 hours post-dose vs. placebo in those who could identify prodrome symptoms that were reliably followed by headache ¹- UBRELVY is the first and only acute treatment for migraine that has demonstrated data in the prodrome phase in a Phase 3, double-blind, placebo-controlled trial
- AbbVie is the only company with three prescription treatments designed to meet patient needs across the full spectrum of migraine

NORTH CHICAGO, Ill., Nov. 16, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today 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.¹

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.^2,3 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.^4,5

"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, vice president, neuroscience development, AbbVie. "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."

During the trial, patients with migraine who could identify prodromal symptoms that led to headache at least 75% of the time (N=518), 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 (P<0.0001).¹
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 events (P<0.0001).¹
More patients had normal function within the 24 hours after treatment of qualifying prodrome events with UBRELVY than after treatment with placebo [Odds Ratio (OR) 1.66, 95% Confidence Interval (CI) 1∙40–1∙96; P<0.0001].¹
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 (P<0.0001).¹

The safety population included 480 patients, and the efficacy analysis population included 477 patients.¹ The most commonly reported prodrome symptoms in the study were sensitivity to light, fatigue, neck pain, sensitivity to sound and dizziness/lightheadedness.¹ UBRELVY was well-tolerated with no new safety signals observed when administered during the prodrome.¹The 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%).

"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, M.D., Ph.D., 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."

About the PRODROME study
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.

About UBRELVY^® (ubrogepant)
UBRELVY^® is an 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.

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.

IMPORTANT SAFETY INFORMATION
Do not take UBRELVY if you are taking medicines known as strong CYP3A4 inhibitors, such as ketoconazole, clarithromycin, or itraconazole, or if you are allergic to UBRELVY or any of its ingredients.

Before taking UBRELVY, tell your healthcare provider about all your medical conditions, including if you:

Have liver problems
Have kidney problems
Are pregnant or plan to become pregnant
Are breastfeeding or plan to breastfeed

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your healthcare provider can tell you if it is safe to take UBRELVY with other medicines.

UBRELVY may cause serious side effects, including allergic reactions. Most reactions happened within hours after taking UBRELVY and were not serious. Some reactions may occur days after taking UBRELVY. Call your healthcare provider or get emergency help right away if you have swelling of the face, mouth, tongue, or throat or trouble breathing.

The most common side effects of UBRELVY are nausea (4%) and sleepiness (3%). These are not all of the possible side effects of UBRELVY.

Please see UBRELVY full Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help.
Visit AbbVie.com/myAbbVieAssist to learn more.

About Migraine
Migraine is a complex neurological disease with recurrent attacks that are often incapacitating and characterized by severe, throbbing headache pain as well as compounding associated symptoms like extreme sensitivity to light, sound or nausea.² 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.^6-9

About AbbVie in Migraine
AbbVie is the only company with three prescription treatments designed to meet patient needs across the full spectrum of migraine to help patients living with this debilitating disease. At AbbVie, we are committed to empowering people living with migraine disease. We advance science that enables healthcare providers to care for people impacted across the spectrum of migraine. Through education and partnerships with the migraine community, we strive to help those with migraine navigate barriers to care, access effective treatments and reduce the impact of migraine on their lives.

About AbbVie 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.

About AbbVie
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. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube.

Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2022 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

US-UBR-230568

Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants (UBR Prodrome). ClinicalTrials.gov. Updated May 31, 2023. Accessed October 18, 2023. https://clinicaltrials.gov/study/NCT04492020?cond=PRODROME%20migraine&aggFilters=phase:3,results:with&rank=1
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Katsarava Z, Buse DC, Manack AN, Lipton RB. Defining the differences between episodic migraine and chronic migraine. Curr Pain Headache Rep. 2012;16:86-92.