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:
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:
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™:
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)
UBRELVY™ (ubrogepant)
Atogepant
Migraine
BOTOX® Indications
BOTOX® is a prescription medicine that is injected into muscles and used:
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.
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®:
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.
SOURCE AbbVie