NORTH CHICAGO, Ill.,
Sept. 8, 2021 /PRNewswire/
-- AbbVie (NYSE: ABBV) today announced that data from its
migraine portfolio will be presented at the International Headache
Congress 2021, held jointly this year by the International Headache
Society and the European Headache Federation, from September 8-12. The company will share a total of
23 abstracts, including two oral presentations and one abstract
lecture.
"We continue to conduct research that seeks to provide
additional insights into the safety, efficacy and clinical utility
of our approved and investigational migraine therapies," said
Michael Gold, M.D., vice president,
neuroscience development, AbbVie. "The data we're presenting are a
result of AbbVie's ongoing commitment to driving progress in the
migraine community."
Among the new data being presented are results from an
open-label, multicenter extension to the pivotal Phase 3 ADVANCE
trial evaluating the long-term safety and tolerability of
atogepant, an investigational, orally administered calcitonin
gene-related peptide receptor antagonist developed for the
preventive treatment of migraine over 40 weeks. Researchers will
also share data from the Phase 1, single-center, open-label,
multiple-dose study assessing the potential for pharmacokinetic
drug-drug interactions between atogepant and topiramate; the
observational cross-sectional UNIVERSE study examining real-world
effectiveness and patient satisfaction of ubrogepant for acute
migraine treatment; and the POLARIS study, a retrospective claims
data analysis examining the real-world treatment patterns of oral
migraine preventive medication by pharmacologic class in people
with migraine.
Additional presentations will focus on the efficacy of atogepant
for the preventive treatment of migraine based on further analyses
from the ADVANCE trial, the safety and tolerability of
investigational ubrogepant as a potential acute treatment for
perimenstrual migraine, and real-world evidence regarding the
safety and efficacy of CGRP monoclonal antibody therapy added to
BOTOX® (onabotulinumtoxinA) for migraine prevention in
adult patients with chronic migraine. Results from a post-hoc
analysis of the Phase 3 PREEMPT trials evaluating the use of
BOTOX® for chronic migraine will also be presented.
AbbVie abstracts and presentation details for IHC 2021 are
outlined below.
Abstract
Title
|
Presentation
Details
All times
CT
|
Atogepant
|
Long-Term Safety and
Tolerability of Atogepant 60 mg Following Once Daily Dosing Over 1
Year for the Preventive Treatment of Migraine
|
ePoster
September 11,
2021
3:42 a.m.
CT
|
Atogepant 60 mg
Once-Daily Shows Efficacy for the Preventive Treatment of Migraine:
Results From a 52-Week Open-Label Extension Trial
|
ePoster (on-demand
only)
September 8,
2021
1 a.m.-1:15 p.m.
CT
|
Atogepant
Significantly Reduces Mean Monthly Migraine Days in the Phase 3
Trial (ADVANCE) for the Prevention of Migraine
|
ePoster (on-demand
only)
September 8,
2021
1 a.m.-1:15 p.m.
CT
|
Effects of Atogepant
as Evaluated by the Activity Impairment in Migraine-Diary (AIM-D)
and Headache Impact Test (HIT-6) in a 12-Week, Double-blind,
Randomized Phase 3 (ADVANCE) Trial for Preventive Treatment of
Migraine
|
ePoster (on-demand
only)
September 8,
2021
1 a.m.-1:15 p.m.
CT
|
Atogepant Improved
Patient-Reported Migraine-Specific Quality of Life in a 12-Week
Phase 3 (ADVANCE) Trial for Preventive Treatment of
Migraine
|
ePoster (on-demand
only)
September 8,
2021
1 a.m.-1:15 p.m.
CT
|
Oral Daily Atogepant
for the Preventive Treatment of Migraine Increases Responder Rates
for Reduction in Mean Monthly Migraine Days
|
ePoster (on-demand
only)
September 8,
2021
1 a.m.-1:15 p.m.
CT
|
Daily Dosing of Oral
Atogepant Improved Patient-Reported Measures of Quality of Life,
Activity Impairment, and Headache Impact in a 52-week
Trial
|
ePoster (on-demand
only)
September 8,
2021
1 a.m.-1:15 p.m.
CT
|
Daily Atogepant
Provides a Rapid Onset and Sustained Benefit in the Preventive
Treatment of Migraine
|
ePoster (on-demand
only)
September 8,
2021
1 a.m.-1:15 p.m.
CT
|
Evaluation of The
Long-Term Safety and Tolerability of Oral Atogepant 60 mg Once
Daily for Preventive Treatment of Migraine: A Phase 3, 40-Week,
Multicenter Extension to the ADVANCE Trial
|
Abstract
Lecture
September 12,
2021
2:45-2:55 a.m.
CT
|
Evaluation of the
Pharmacokinetic Interaction and Safety of Coadministered Atogepant
and Topiramate
|
ePoster (on-demand
only)
September 8,
2021
1 a.m.-1:15 p.m.
CT
|
Ubrogepant
|
Preventive Oral
Migraine Treatment Utilization Patterns (POLARIS STUDY): A
Retrospective Claims Data Analysis
|
ePoster
September 11,
2021
4:51 a.m.
CT
|
COmbining UbRogepAnt
and Preventives for miGrainE (COURAGE) Study Using the Migraine
Buddy Application: A Novel, Entirely Remote Design for Collecting
Real-World Evidence
|
ePoster (on-demand
only)
September 8,
2021
1 a.m.-1:15 p.m.
CT
|
Ubrogepant Users'
Experience - Patients on Ubrogepant, Characteristics and Outcomes
(UNIVERSE STUDY)
|
Oral
Presentation
September 11,
2021
3:20 a.m.
CT
|
A Novel Approach to
Defining Success in the Acute Treatment of Migraine: Demonstrating
Therapeutic Benefit at 1 Hour Post-Dose in the Pooled ACHIEVE I and
ACHIEVE II Trials
|
ePoster (on-demand
only)
September 8,
2021
1 a.m.-1:15 p.m.
CT
|
A Novel Approach to
Defining Success in the Acute Treatment of Migraine: Pooled Results
From the ACHIEVE I and ACHIEVE II Trials
|
ePoster (on-demand
only)
September 8,
2021
1 a.m.-1:15 p.m.
CT
|
Ubrogepant Was Safe
and Well Tolerated in the Acute Treatment of Perimenstrual
Migraine
|
ePoster (on-demand
only)
September 8,
2021
1 a.m.-1:15 p.m.
CT
|
Ubrogepant Treatment
When Pain Is Mild Increases the Likelihood of Achieving Pain
Freedom in Participants Who Treated Migraine Attacks of Mild and
Moderate or Severe Pain
|
ePoster (on-demand
only)
September 8,
2021
1 a.m.-1:15 p.m.
CT
|
BOTOX®
(onabotulinumtoxinA)
|
Real-World Evidence
for Control of Patients With Chronic Migraine Who Received
Calcitonin Gene‒Related Peptide Monoclonal Antibody Therapy Added
to OnabotulinumtoxinA Treatment
|
ePoster (on-demand
only)
September 8,
2021
1 a.m.-1:15 p.m.
CT
|
Optimal Acute
Treatment Is Associated With Productivity Gains in People With
Migraine: Results From the Chronic Migraine Epidemiology and
Outcomes (CaMEO) Study
|
ePoster
September 11,
2021
3:39 a.m.
CT
|
Consecutive
Headache-Free Days With OnabotulinumtoxinA Treatment in Patients
With Chronic Migraine: A Pooled PREEMPT Analysis
|
ePoster (on-demand
only)
September 8,
2021
1 a.m.-1:15 p.m.
CT
|
Real-World Evidence
for the Safety and Efficacy of CGRP Monoclonal Antibody Therapy
Added to OnabotulinumtoxinA Treatment for Migraine Prevention in
Adult Patients with Chronic Migraine
|
ePoster
September 11,
2021
4:12 a.m.
CT
|
Impact of Prior
Monthly Headache Days on Migraine-Related Quality of Life: Results
From the CaMEO Study
|
ePoster (on-demand
only)
September 8,
2021
1 a.m.-1:15 p.m.
CT
|
Characterizing
Preventive Treatment Gaps in Migraine: Results From the CaMEO
Study
|
Oral
Presentation
September 10,
2021
8:15 a.m.
CT
|
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. Atogepant is
currently under review by the U.S. FDA.
About
BOTOX®
BOTOX® was first
approved by the FDA in 1989 for two rare eye muscle disorders –
blepharospasm and strabismus in adults. Today, BOTOX® is
FDA-approved for 12 therapeutic indications, including Chronic
Migraine, overactive bladder, leakage of urine (incontinence) due
to overactive bladder caused by a neurologic condition in adults,
cervical dystonia, adult and pediatric spasticity, severe underarm
sweating (axillary hyperhidrosis), and pediatric detrusor
overactivity associated with a neurologic condition.
BOTOX® (onabotulinumtoxinA) Important
Information in the United
States
Indications
BOTOX® is a prescription
medicine that is injected into muscles and used:
- To treat overactive bladder symptoms such as a strong need to
urinate with leaking or wetting accidents (urge urinary
incontinence), a strong need to urinate right away (urgency), and
urinating often (frequency) in adults 18 years and older when
another type of medicine (anticholinergic) does not work well
enough or cannot be taken
- To treat leakage of urine (incontinence) in adults 18 years and
older with overactive bladder caused by a neurologic disease who
still have leakage or cannot tolerate the side effects after trying
an anticholinergic medication
- To treat overactive bladder due to a neurologic disease in
children 5 years of age and older when another type of medicine
(anticholinergic) does not work well enough or cannot be taken
- 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
- To treat increased muscle stiffness in people 2 years of age
and older with spasticity
- To treat the abnormal head position and neck pain that happens
with cervical dystonia (CD) in people 16 years and older
- To treat certain types of eye muscle problems (strabismus) or
abnormal spasm of the eyelids (blepharospasm) in people 12 years of
age and older
BOTOX® is also injected into the skin to treat the
symptoms of severe underarm sweating (severe primary axillary
hyperhidrosis) when medicines used on the skin (topical) do not
work well enough in people 18 years and older.
It is not known whether BOTOX® is safe and effective
to prevent headaches in patients with migraine who have 14 or fewer
headache days each month (episodic migraine).
BOTOX® has not been shown to help people perform
task-specific functions with their upper limbs or increase movement
in joints that are permanently fixed in position by stiff
muscles.
It is not known whether BOTOX® is safe and effective
for severe sweating anywhere other than your armpits.
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, severe
underarm sweating, blepharospasm, or strabismus.
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.
Do not receive BOTOX® for the
treatment of urinary incontinence if you: have a urinary tract
infection (UTI) or cannot empty your bladder on your own and are
not routinely catheterizing. Due to the risk of urinary retention
(not being able to empty the bladder), only patients who are
willing and able to initiate catheterization post treatment, if
required, should be considered for treatment.
Patients treated for overactive bladder:
In clinical
trials, 36 of the 552 patients had to self-catheterize for urinary
retention following treatment with BOTOX® compared to 2
of the 542 treated with placebo. The median duration of
post-injection catheterization for these patients treated with
BOTOX® 100 Units (n = 36) was 63 days (minimum 1 day to
maximum 214 days) as compared to a median duration of 11 days
(minimum 3 days to maximum 18 days) for patients receiving placebo
(n = 2). Patients with diabetes mellitus treated with
BOTOX® were more likely to develop urinary retention
than nondiabetics.
Adult Patients treated for overactive bladder due to
neurologic disease:
In clinical trials, 30.6% of patients
(33/108) who were not using clean intermittent catheterization
(CIC) prior to injection, required catheterization for urinary
retention following treatment with BOTOX® 200 Units as
compared to 6.7% of patients (7/104) treated with placebo. The
median duration of post-injection catheterization for these
patients treated with BOTOX® 200 Units (n = 33) was 289
days (minimum 1 day to maximum 530 days) as compared to a median
duration of 358 days (minimum 2 days to maximum 379 days) for
patients receiving placebo (n = 7). Among patients not using CIC at
baseline, those with MS were more likely to require CIC post
injection than those with SCI.
The dose of BOTOX® is not the same as,
or comparable to, another botulinum toxin product.
Serious and/or immediate allergic reactions have been
reported, including itching, rash, red itchy welts, wheezing,
asthma symptoms, 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 if you have any breathing-related
problems. Your doctor may monitor you for breathing problems
during treatment with BOTOX® for spasticity or for
detrusor overactivity associated with a neurologic condition. The
risk of developing lung disease in patients with reduced lung
function is increased in patients receiving BOTOX®.
Cornea problems have been reported. Cornea (surface of
the eye) problems have been reported in some people receiving
BOTOX® for their blepharospasm, especially in people
with certain nerve disorders. BOTOX® may cause the
eyelids to blink less, which could lead to the surface of the eye
being exposed to air more than is usual. Tell your doctor if you
experience any problems with your eyes while receiving
BOTOX®. Your doctor may treat your eyes with drops,
ointments, contact lenses, or with an eye patch.
Bleeding behind the eye has been reported. Bleeding
behind the eyeball has been reported in some people receiving
BOTOX® for their strabismus. Tell your doctor if you
notice any new visual problems while receiving
BOTOX®.
Bronchitis and upper respiratory tract infections (common
colds) have been reported. Bronchitis was reported more
frequently in adults receiving BOTOX® for upper limb
spasticity. Upper respiratory infections were also reported more
frequently in adults with prior breathing-related problems with
spasticity. In pediatric patients treated with BOTOX®
for upper limb spasticity, upper respiratory tract infections were
reported more frequently. In pediatric patients treated with
BOTOX® for lower limb spasticity, upper respiratory
tract infections were not reported more frequently than
placebo.
Autonomic dysreflexia in patients treated for overactive
bladder due to neurologic disease. Autonomic dysreflexia
associated with intradetrusor injections of BOTOX® could
occur in patients treated for detrusor overactivity associated with
a neurologic condition and may require prompt medical therapy. In
clinical trials, the incidence of autonomic dysreflexia was greater
in adult patients treated with BOTOX® 200 Units compared
with placebo (1.5% versus 0.4%, respectively).
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; have symptoms of a urinary tract infection (UTI) and
are being treated for urinary incontinence (symptoms of a urinary
tract infection may include pain or burning with urination,
frequent urination, or fever); have problems emptying your bladder
on your own and are being treated for urinary incontinence; are
pregnant or plan to become pregnant (it is not known if
BOTOX® can harm your unborn baby); are breastfeeding or
plan to (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 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 by injection; take muscle
relaxants; take an allergy or cold medicine; take a sleep medicine;
take aspirin-like products or blood thinners.
Other side effects of
BOTOX® include: dry mouth, discomfort or
pain at the injection site, tiredness, headache, neck pain, eye
problems: double vision, blurred vision, decreased eyesight,
drooping eyelids, swelling of your eyelids, dry eyes; drooping
eyebrows; and upper respiratory tract infection. In adults being
treated for urinary incontinence, other side effects include
urinary tract infection and painful urination. In children being
treated for urinary incontinence, other side effects include
urinary tract infection and bacteria in the urine. If you have
difficulty fully emptying your bladder on your own after receiving
BOTOX®, you may need to use disposable self-catheters to
empty your bladder up to a few times each day until your bladder is
able to start emptying again.
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 Product
Information, including Boxed Warning
and Medication Guide.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
About UBRELVY® (ubrogepant) in the United
States
UBRELVY® (ubrogepant)
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 to directly block CGRP, a protein
released during a migraine attack, from binding to its
receptors.
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.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
About AbbVie in Migraine
Impacting one billion people
worldwide, migraine is a neurological disease with recurring
attacks that causes pain and other disabling symptoms. However,
migraine can be treatable. At AbbVie, we are committed to
empowering people in their pursuit of migraine freedom. 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 reclaim 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 and a robust pipeline in neurological and psychiatric
disorders, including Alzheimer's disease, bipolar I disorder, major
depressive disorder, migraine, Parkinson's disease, spinal cord
injuries, post-stroke spasticity, schizophrenia, stroke and
others.
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 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 2020 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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