- 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.1 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%).
"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
- Headache Classification Committee of the International Headache
Society. The International Classification of Headache Disorders,
3rd edition. Cephalalgia 2018; 38: 1–211.
- Laurell K, Artto V, Bendtsen L, et al. Premonitory symptoms in
migraine: a cross-sectional study in 2714 persons. Cephalalgia
2016; 36: 951–59.
- Giffin NJ, Ruggiero L, Lipton RB, et al. Premonitory symptoms
in migraine: an electronic diary study. Neurology 2003; 60:
935–40.
- Lipton RB, Pavlovic JM, Haut SR, Grosberg BM, Buse DC.
Methodological issues in studying trigger factors and premonitory
features of migraine. Headache 2014; 54: 1661–69.
- Amiri P, Kazeminasab S, Nejadghaderi SA, Mohammadinasab R,
Pourfathi H, Araj-Khodaei M, Sullman MJM, Kolahi AA, Safiri S.
Migraine: A Review on Its History, Global Epidemiology, Risk
Factors, and Comorbidities. Front Neurol. 2022 Feb 23;12:800605.
doi: 10.3389/fneur.2021.800605. PMID: 35281991; PMCID:
PMC8904749.
- Steiner, T. J., Stovner, L. J., Vos, T., Jensen, R., &
Katsarava, Z. Migraine is first cause of disability in under 50s:
Will health politicians now take notice? J Headache Pain.
2018;19:17.
- AbbVie. Data on File: ABVRRTI73750
- 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.
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