NORTH CHICAGO, Ill.,
June 15, 2020 /PRNewswire/
-- AbbVie (NYSE: ABBV), a research-based global
biopharmaceutical company, today announced that it has 27 studies
accepted to the virtual 2020 Annual Scientific Meeting of the
American Headache Society (AHS). These abstracts highlight the
company's ongoing innovation in migraine, including its
investigational product, atogepant, while reinforcing the efficacy
and safety profiles of BOTOX® and UBRELVY™.
"We are looking forward to highlighting the magnitude and
breadth of our expanding migraine portfolio to help serve the needs
of this underserved patient community," said Thomas J. Hudson, Senior Vice President,
Research & Development and Chief Scientific Officer, AbbVie.
"This leading research underscores our commitment to addressing the
full spectrum of migraine with multiple treatment options and to
making a meaningful difference in the lives of patients with this
debilitating neurological disease. We are thankful the American
Headache Society continues to recognize these significant
scientific advancements."
BOTOX® is a mainstay preventive treatment for Chronic Migraine
and will be featured in several presentations. BOTOX® has been
approved for 30 years since its first FDA approval in 1989 for two
rare muscle disorders – blepharospasm and strabismus in adults. The
following 29-year retrospective analysis of BOTOX®-exposed mothers
demonstrates the depth of understanding of use in clinical practice
and will be featured as a podium presentation:
- Pregnancy Outcomes Following Exposure to OnabotulinumtoxinA
Update: 29 Years of Safety Observation. Authors: Brin M, et
al.
The following real-world studies evaluated treatment persistence
in adults with migraine treated with OnabotulinumtoxinA and
calcitonin gene-related peptide (CGRP) monoclonal antibodies
(mAbs). The studies were similar in design using claims and
electronic health record databases. The studies demonstrated that
significantly more patients starting OnabotulinumtoxinA were
persistent with their treatment compared to those starting on CGRP
mAbs for migraine. Future research is warranted to confirm these
findings as more long-term data become available:
- Real-World Persistence in Patients Treated with
OnabotulinumtoxinA or Calcitonin Gene–Related Peptide Monoclonal
Antibodies (CGRP mAbs) for Migraine: A Large US Administrative
Claims Database Study. Authors: Ta J, et al.
- Persistence to OnabotulinumtoxinA Versus Calcitonin
Gene–Related Peptide Monoclonal Antibodies (CGRP mAbs) Among
Migraine Patients in a US Electronic Health Record Database.
Authors: Tung A, et al.
Results from several studies, including PREDICT, PREEMPT and
COMPEL also add to the large body of evidence evaluating the
long-term safety and sustained efficacy of BOTOX®. These studies
assessed clinically relevant improvements among patients treated
with BOTOX®, such as healthcare resource utilization, consecutive
headache-free days, persistent response from treatment, headache
severity, and health-related quality of life, among others.
UBRELVY™, approved in December of 2019, is a first-to-market,
orally-administered CGRP receptor antagonist (or gepant) for the
acute treatment of migraine. Key presentations will highlight
pivotal studies evaluating the safety, efficacy and tolerability of
UBRELVY™:
- Pharmacokinetics, Safety, and Tolerability of Ubrogepant for
the Acute Treatment of Migraine Following Coadministration with
Preventive Monoclonal Antibody Treatment. Authors: Jakate A, et
al.: This Phase I study demonstrated that UBRELVY™ appears safe and
well-tolerated when co-administered with a monoclonal antibody CGRP
targeted therapy in a population with migraine. There was no
significant change in the pharmacokinetic (PK) profile of UBRELVY™
when co-administered with erenumab or galcanezumab, and there were
no safety concerns identified.
- Efficacy and Safety of Ubrogepant in Participants Taking
Concomitant Preventive Medication. Authors: Blumenfeld A, et
al.: An analysis of 2246 participants from the ACHIEVE trials
demonstrated that concomitant preventive medication use did not
impact the efficacy of UBRELVY™ for the acute treatment of
migraine, and no safety signal was identified with concomitant
use.
- Ubrogepant is Effective in the Acute Treatment of Migraine
with Mild Pain. Authors: Lipton R, et al.: In addition to
effectively treating migraine attacks when pain is moderate or
severe, UBRELVY™ long-term trial data indicated that treating when
pain is mild may significantly improve rates of pain freedom and
absence of migraine-associated symptoms.
- Ubrogepant Does Not Induce Latent Sensitization in a
Preclinical Model of Medication Overuse Headache. Authors:
Navratilova E, et al.: Preclinical data suggested that repeated
treatment with UBRELVY™ is unlikely to produce the neural
adaptations that underlie medication overuse headache (MOH).
AbbVie continues to advance its migraine program with atogepant,
an investigational small molecule oral CGRP receptor antagonist (or
gepant) currently in Phase 3 development specifically designed for
the prevention of migraine. Key studies presented during this
Congress evaluated the PK, safety and tolerability profiles of the
investigational drug in addition to the potential for PK drug-drug
interactions (DDIs) between atogepant and other compounds.
Following is the full list of accepted abstracts based on
treatment and category, which is also accessible
HERE.
BOTOX® (onabotulinumtoxinA)
- Pregnancy Outcomes Following Exposure to OnabotulinumtoxinA
Update: 29 Years of Safety Observation. Authors: Brin M, et
al.
- Responder Rates to OnabotulinumtoxinA in Patients with
Chronic Migraine: A Post Hoc Analysis of the COMPEL Study.
Authors: Rothrock J, et al.
- Benefits of Long-Term OnabotulinumtoxinA Treatment in
Chronic Migraine: Results from the COMPEL Study. Authors:
Blumenfeld A, et al.
- Real-World Persistence in Patients Treated with
OnabotulinumtoxinA or Calcitonin Gene–Related Peptide Monoclonal
Antibodies (CGRP mAbs) for Migraine: A Large US Administrative
Claims Database Study. Authors: Ta J, et al.
- Persistence to OnabotulinumtoxinA Versus Calcitonin
Gene–Related Peptide Monoclonal Antibodies (CGRP mAbs) Among
Migraine Patients in a US Electronic Health Record Database.
Authors: Tung A, et al.
- Healthcare Resource Utilization and Health-Related Quality
of Life in Adult Patients with Chronic Migraine: Results from the
PREDICT Study. Authors: Boudreau G, et al.
- OnabotulinumtoxinA Treatment Improved Health-Related Quality
of Life in Adults with Chronic Migraine: Results from a
Prospective, Observational Study (PREDICT). Authors: Boudreau
G, et al.
- Sustained Benefits of OnabotulinumtoxinA Treatment in
Chronic Migraine: Results from a PREEMPT Pooled Analysis.
Authors: Silberstein S, et al.
- Consecutive Headache-Free Days After Long-term Treatment
with OnabotulinumtoxinA in Patients with Chronic Migraine: A Post
Hoc Analysis of the Pooled PREEMPT Studies. Authors: Diener H,
et al.
- Sustained Clinical Benefits Following OnabotulinumtoxinA
Treatment in Patients with Chronic Migraine: A Post Hoc Analysis of
the Pooled PREEMPT Studies. Authors: Dodick D, et al.
UBRELVY™ (ubrogepant)
- Ubrogepant Does Not Induce Latent Sensitization in a
Preclinical Model of Medication Overuse Headache. Authors:
Navratilova E, et al.
- Efficacy and Safety of Ubrogepant in Participants Taking
Concomitant Preventive Medication. Authors: Blumenfeld A, et
al.
- Pharmacokinetics, Safety, and Tolerability of Ubrogepant for
the Acute Treatment of Migraine Following Coadministration with
Preventive Monoclonal Antibody Treatment. Authors: Jakate A, et
al.
- Ubrogepant is Effective in the Acute Treatment of Migraine
with Mild Pain. Authors: Lipton R, et al.
- Safety and Tolerability of Ubrogepant within Various
Demographic and Clinical Characteristic Subgroups. Authors:
Ailani J, et al.
- Ubrogepant for the Acute Treatment of Migraine: Pooled
Efficacy from ACHIEVE I and ACHIEVE II Phase 3 Trials. Authors:
Hutchinson S, et al.
- Improved Functionality, Satisfaction, and Global Impression
of Change with Ubrogepant for the Acute Treatment of Migraine in
Triptan Insufficient Responders. Authors: Lipton R, et al.
Atogepant
- Single Therapeutic Doses of Atogepant Are Not Associated
with a Clinically Relevant Drug-Drug Interaction When
Coadministered with Acetaminophen or Naproxen. Authors:
Boinpally R, et al.
- Pharmacokinetics and Safety of Single-Dose Atogepant in
Participants with Hepatic Impairment. Authors: Boinpally R, et
al.
- Multiple, Once-Daily, Oral Doses of 170 mg Atogepant for 28
Days Are Safe and Well Tolerated with No Clinically Significant
Effect on Alanine Aminotransferase in Healthy Adults. Authors:
Min K, et al.
- Coadministration of Single Therapeutic Oral Doses of
Atogepant and Sumatriptan Produces No Clinically Relevant Drug-Drug
Interactions. Authors: Boinpally R, et al.
- A Single Supratherapeutic Dose of Atogepant Does Not Affect
Cardiac Repolarization in Healthy Adults. Authors: Boinpally R,
et al.
Migraine
- Assessing Barriers to Care in Episodic and Chronic Migraine:
Results from the Chronic Migraine Epidemiology and Outcomes (CaMEO)
Study. Authors: Buse D, et al.
- Gastrointestinal Comorbidities Representing a Relative
Contraindication to NSAID Use: Results from the Chronic Migraine
Epidemiology and Outcomes (CaMEO) Study. Authors: Buse D, et
al.
- Acute Treatment Management Gaps in People with Migraine:
Results of the CaMEO Study. Authors: Buse D, et al.
- Operationalization of Triptan Labels to Identify Migraine
Patients with Cardiovascular Contraindications and Warnings Using
Real-world Claims Data. Authors: Dodick D, et al.
- Exploring the Boundaries Between Episodic and Chronic
Migraine: Results from the CaMEO Study. Authors: Lipton R, et
al.
BOTOX® Indications
BOTOX® is a prescription medicine that is injected into
muscles and used:
- 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 certain types of eye muscle problems (Strabismus) or
abnormal spasm of the eyelids (Blepharospasm) in people 12 years
and 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).
It is not known whether BOTOX® is safe or effective for
other types of muscle spasms.
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,
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 its
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®.
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®.
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 (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 Product Information, including Boxed
Warning and Medication Guide.
UBRELVY™ Indication
UBRELVYTM (ubrogepant)
is indicated for the acute treatment of migraine with or without
aura in adults. UBRELVY is not indicated for the preventive
treatment of migraine.
IMPORTANT SAFETY INFORMATION
Contraindication: Concomitant use of strong CYP3A4
inhibitors (eg, ketoconazole, itraconazole,
clarithromycin).
Adverse Reactions: The most common adverse reactions were
nausea (4%) and somnolence (3%).
Please see link to full Prescribing Information.
About Atogepant
Atogepant is an orally-administered,
CGRP receptor antagonist specifically in development for the
preventive treatment of migraine. With multiple dose strengths,
dosing flexibility, and rapid onset without titration, atogepant is
an ideal candidate for preventive treatment. 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.
About AbbVie
AbbVie is a global, research and
development-based biopharmaceutical company committed to developing
innovative advanced therapies for some of the world's most complex
and critical conditions. The company's mission is to use its
expertise, dedicated people and unique approach to innovation to
markedly improve treatments across four primary therapeutic areas:
immunology, oncology, virology and neuroscience. In more than
75 countries, AbbVie employees are working every day to advance
health solutions for people around the world. For more information
about AbbVie, please visit us at www.abbvie.com.
Follow @abbvie on
Twitter, Facebook, LinkedIn or Instagram.
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, competition from
other products, challenges to intellectual property, 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 2019 Annual Report on Form
10-K, which has been filed with the Securities and Exchange
Commission. 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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SOURCE AbbVie