NORTH CHICAGO, Ill.,
Oct. 2, 2020 /PRNewswire/ -- AbbVie
(NYSE: ABBV) today announced it will present results from several
clinical trials, including new data from the Phase 3 ADVANCE trial,
evaluating the efficacy and safety of the investigational medicine
atogepant, an orally administered calcitonin gene-related peptide
(CGRP) receptor antagonist (gepant), for the prevention of
migraine, at the 2020 Virtual Migraine Trust International
Symposium (MTIS), October 3-9. In
total, 15 abstracts will be presented evaluating the safety,
efficacy, and impact on patients and the healthcare system of
AbbVie's migraine treatment portfolio, including BOTOX®
(onabotulinumtoxinA) and UBRELVY® (ubrogepant).
Migraine is a complex, chronic disease with episodic attacks
that are often incapacitating and characterized by headache pain as
well as neurologic and autonomic
symptoms.2 It is highly prevalent,
affecting more than 1 billion people worldwide, and is one of
the highest causes of disability worldwide for people under 50
years of age.3,4 Daily activities, work, school,
and personal relationships can be negatively affected by migraine,
leading to a significant burden on the person with migraine, their
family, and friends, and often extending to employers and
healthcare systems.
"Migraine attacks can be unpredictable, and the frequency and
severity of these attacks often fluctuate, making it very
challenging for people with migraine to manage their symptoms,"
Michael Gold, MD, vice president,
neuroscience development, AbbVie. "The clinical trial results and
real-world data being presented at MTIS demonstrate our efforts
working with scientists and healthcare professionals from around
the world to research potential solutions for people with migraine
to either treat or prevent their migraine attacks."
Studies Evaluating Atogepant
Data from three abstracts
will be presented, including new results from the Phase 3 ADVANCE
trial, which evaluated the safety and efficacy of atogepant for the
preventive treatment of migraine. The data will be presented at an
oral session on Wednesday, October 7,
at 12:25 p.m. EDT/5:25 BST.
The topline results from the ADVANCE trial were announced in a
press release issued in July
2020, and additional data from this trial will be presented
at upcoming medical congresses.
Additionally, two Phase 1 trials assessing the potential
drug-to-drug interactions of atogepant combined with sumatriptan, a
serotonin receptor antagonist that is commonly used as an acute
treatment of migraine in the U.S., and atogepant in combination
with acetaminophen or naproxen, two commonly-used pain relievers,
will be presented as posters, available on demand October 3-9.
Studies Evaluating BOTOX®
(onabotulinumtoxinA)
Findings from nine abstracts evaluating
treatment with BOTOX® in clinical and real-world
settings will be presented as posters, also available on demand
October 3-9.
Notably, these presentations include a real-world data analysis
of the safety and tolerability of adding calcitonin
gene–related peptide (CGRP) monoclonal antibodies (mAbs) to
BOTOX® for the treatment of chronic migraine, real-world
evidence from the PREDICT study evaluating the impact of
BOTOX® treatment on healthcare resource utilization and
health-related quality of life in patients with chronic migraine,
and a 29-year retrospective analysis evaluating pregnancy outcomes
in women exposed to BOTOX®, including more than 30
percent of women with migraine.
Studies Evaluating UBRELVY® (ubrogepant)
Three
abstracts evaluating UBRELVY®, which is currently approved in the
U.S. for the acute treatment of migraine with or without aura in
adults, demonstrating efficacy in treating migraine with
moderate-to-severe pain,5 will be
presented. These include an oral presentation of results from
the Phase 3 trial evaluating the safety and efficacy of UBRELVY®
for acute treatment of migraine when pain is mild on Wednesday, October 7, at 12:05 p.m. EDT/5:05
BST.
Additionally, results from an analysis of the ACHIEVE I and II
trials, which evaluated the impact of concomitant preventive
medication use on the efficacy and safety of URBRELVY for the acute
treatment of migraine, will be presented as a poster, available on
demand October 3-9.
About AbbVie Leadership in Migraine
AbbVie, a leader
in the migraine space, markets BOTOX®
(onabotulinumtoxinA), the first FDA-approved, preventive treatment
for adults with Chronic Migraine and UBRELVY®
(ubrogepant), the first FDA-approved oral calcitonin gene-related
peptide (CGRP) receptor antagonist (gepant), which is indicated for
the acute treatment of migraine with or without aura in adults.
About Atogepant
Atogepant is an investigational orally
administered, CGRP receptor antagonist (gepant) specifically
developed for the preventive treatment of migraine. CGRP and its
receptors are expressed in regions of the nervous system associated
with migraine pathophysiology. Studies have shown that CGRP levels
are elevated during migraine attacks and selective CGRP receptor
antagonists confer clinical benefit in migraine.
BOTOX® Indications
BOTOX® is a prescription
medicine that is injected to prevent headaches in adults with
chronic migraine who have 15 or more days each month with headache
lasting 4 or more hours each day in people 18 years or older.
It is not known whether BOTOX® is safe or effective to prevent
headaches in patients with migraine who have 14 or fewer headache
days each month (episodic migraine).
IMPORTANT SAFETY INFORMATION
BOTOX® may cause serious side effects that can be life
threatening. Get medical help right away if you have
any of these problems any time (hours to weeks) after injection of
BOTOX®:
- Problems swallowing, speaking, or breathing, due to
weakening of associated muscles, can be severe and result in loss
of life. You are at the highest risk if these problems are
pre-existing before injection. Swallowing problems may last for
several months
- Spread of toxin effects. The effect of botulinum
toxin may affect areas away from the injection site and cause
serious symptoms including: loss of strength and all-over muscle
weakness, double vision, blurred vision and drooping eyelids,
hoarseness or change or loss of voice, trouble saying words
clearly, loss of bladder control, trouble breathing, and trouble
swallowing
There has not been a confirmed serious case of spread of toxin
effect away from the injection site when BOTOX® has
been used at the recommended dose to treat chronic migraine.
BOTOX® may cause loss of strength or general muscle weakness,
vision problems, or dizziness within hours to weeks of taking
BOTOX®. If this happens, do not drive a car, operate machinery,
or do other dangerous activities.
Do not receive BOTOX® if you: are allergic to any of the
ingredients in BOTOX® (see Medication Guide for ingredients); had
an allergic reaction to any other botulinum toxin product such as
Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or
Xeomin® (incobotulinumtoxinA); have a skin infection at the planned
injection site.
The dose of BOTOX® is not the same as, or comparable to, any
other botulinum toxin product.
Serious and/or immediate allergic reactions have been
reported, including itching, rash, red itchy welts, wheezing,
asthma symptoms, or dizziness or feeling faint. Get medical help
right away if you experience symptoms; further injection of BOTOX®
should be discontinued.
Tell your doctor about all your muscle or nerve
conditions such as ALS or Lou
Gehrig's disease, myasthenia gravis, or Lambert-Eaton
syndrome, as you may be at increased risk of serious side effects
including difficulty swallowing and difficulty breathing from
typical doses of BOTOX®.
Tell your doctor about all your medical conditions, including
if you: have or have had bleeding problems; have plans to have
surgery; had surgery on your face; weakness of forehead muscles;
trouble raising your eyebrows; drooping eyelids; any other abnormal
facial change; are pregnant or plan to become pregnant (it is not
known if BOTOX® can harm your unborn baby); are breastfeeding or
plan to breastfeed (it is not known if BOTOX® passes into breast
milk).
Tell your doctor about all the medicines you take,
including prescription and over-the-counter medicines, vitamins,
and herbal supplements. Using BOTOX® with certain other medicines
may cause serious side effects. Do not start any new medicines
until you have told your doctor that you have received BOTOX® in
the past.
Tell your doctor if you have received any other botulinum toxin
product in the last 4 months; have received injections of botulinum
toxin such as Myobloc®, Dysport®, or Xeomin® in the past (tell your
doctor exactly which product you received); have recently received
an antibiotic injection; take muscle relaxants; take allergy or
cold medicines; take sleep medicine; take aspirin-like products or
blood thinners.
Other side effects of BOTOX® include: dry mouth,
discomfort or pain at injection site, tiredness, headache, neck
pain, eye problems: double vision, blurred vision, decreased
eyesight, drooping eyelids, swelling of your eyelids, dry eyes;
drooping eyebrows.
For more information refer to the Medication Guide or talk
with your doctor.
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.
Please see BOTOX® full Prescribing Information,
including Boxed Warning and Medication Guide.
IMPORTANT SAFETY INFORMATION
Who should not take
UBRELVY® (ubrogepant)?
Do not take UBRELVY® if you are taking medicines known as strong
CYP3A4 inhibitors, such as ketoconazole, clarithromycin,
itraconazole.
What should I tell my healthcare provider 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.
What are the most common side effects of UBRELVY®?
The
most common side effects are nausea (4%) and sleepiness (3%). These
are not all of the possible side effects of UBRELVY®.
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 to
prevent migraine headaches.
Please see full Prescribing
Information.
About UBRELVY® (ubrogepant)
UBRELVY® (ubrogepant) is a
novel, highly potent, 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. Unlike
older medications, UBRELVY® is the first pill of its kind to
directly block CGRP, a protein released during a migraine attack,
from binding to its receptors. It works without constricting blood
vessels, which some older treatments are known to do.
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 and a robust pipeline in neurological and psychiatric
disorders, including Alzheimer's disease, bipolar disorder and
depression, major depressive disorder, migraine, multiple
sclerosis, Parkinson's disease, spinal cord injuries,
post-stroke spasticity, schizophrenia, and stroke.
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. For more information, please
visit www.abbvie.com.
About AbbVie
AbbVie's mission is to discover and
deliver innovative medicines 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, eye care, virology,
women's health and gastroenterology, in addition to products and
services across its Allergan Aesthetics portfolio. For more
information about AbbVie, please visit us at www.abbvie.com.
Follow @abbvie on
Twitter, Facebook, Instagram, YouTube and LinkedIn.
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, among others, 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
indicated in the forward-looking statements. Such risks and
uncertainties include, but are not limited to, failure to realize
the expected benefits from AbbVie's acquisition of Allergan plc
("Allergan"), failure to promptly and effectively integrate
Allergan's businesses, competition from other products, challenges
to intellectual property, difficulties inherent in the research and
development process, adverse litigation or government action,
changes to laws and regulations applicable to our industry and the
impact of public health outbreaks, epidemics or pandemics, such as
COVID-19. 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 2019 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 to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
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1 Headache Classification Committee
of the International Headache Society (IHS) The International
Classification of Headache Disorders, 3rd edition.
Cephalalgia. 2018;38:1-211.
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2 Headache Classification Committee
of the International Headache Society (IHS) The International
Classification of Headache Disorders, 3rd edition.
Cephalalgia. 2018;38:1-211.
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3 GBD
2016 Disease and Injury Incidence and Prevalence Collaborators.
Global, regional, and national incidence, prevalence, and years
lived with disability for 328 diseases and injuries for 195
countries, 1990-2016: a systematic analysis for the Global Burden
of Disease Study 2016. Lancet.
2017;390:1211-1259.
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4 Steiner TJ, Stovner LJ, 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.
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5 UBRELVY® Prescribing
Information. Available at
https://media.allergan.com/products/Ubrelvy_pi.pdf#page=14.
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SOURCE AbbVie