NORTH CHICAGO, Ill., Aug. 31, 2020 /PRNewswire/ -- Healthy living blogger Becca Ludlum knows all too well the physical and mental toll Chronic Migraine can have. She experienced self-described 'daily unbreaking migraine attacks.' Her story is more common than you think. In the U.S., more than 3.3 million adults live with Chronic Migraine1, and people who experience the burden and disability of migraine disease wait on average four years before speaking with a healthcare professional.2 The campaign 'Say No to Chronic Migraine Monday' urges people living with Chronic Migraine to make an appointment today with a headache specialist to discuss treatment options.
Migraine is a neurological disease characterized by intermittent attacks accompanied by debilitating symptoms, such as headache pain, sensitivity to light and sound, and nausea, that are often incapacitating. People with Chronic Migraine have 15 or more headache days per month, with each headache lasting 4 hours or more, and 8 of those days associated with migraine.3 Chronic Migraine is a distinct neurological disease, and it can negatively impact many aspects of life.
Every Monday throughout September's Pain Awareness Month, campaign ambassadors including Becca, will use the hashtag #ChronicMigraineMonday on Instagram to raise awareness for Chronic Migraine and the importance of finding a treatment. Within their posts, the ambassadors will share their personal motivations and inspiration for seeking treatment.
'Say No to Chronic Migraine Monday' also encourages people to visit www.BOTOXChronicMigraine.com to locate a headache specialist near them to schedule an appointment, and to learn more about BOTOX® (onabotulinumtoxinA) as a treatment option. BOTOX® is a preventive treatment for adults with Chronic Migraine, who have 15 or more headache days a month, each lasting 4 or more hours. BOTOX® is not approved for fewer than 14 headache days a month.
"When people can't physically see you experiencing a headache – like a bruise or a broken arm – they have a hard time understanding and can be judgmental, thinking, 'it's just a headache.' One day I woke up after a series of debilitating migraine attacks and knew I needed to take charge and seek help," said Becca. "Working with my neurologist, I was able to receive a proper Chronic Migraine diagnosis and start treatment with BOTOX®. I saw a significant reduction in the number of headache and migraine days I was experiencing. I am grateful for my family's support with whom I am able to spend time doing what I love – like hanging out with my boys and sharing recipes with my community."
"Many new patients come to me at their wit's end, sharing they have migraine attacks or headaches more often than not," said Dr. Jaclyn Duvall, board-certified neurologist specializing in headache medicine at Utica Park Clinic in Tulsa, OK. "It's crucial for patients to speak openly and honestly about the symptoms they are experiencing with a headache specialist to determine an appropriate diagnosis and treatment. As seen in my clinical practice for nearly a decade, in addition to published safety and efficacy data, BOTOX® is a proven and effective treatment for many of my Chronic Migraine patients in preventing their headaches and migraines before they start and in reducing their number of headache and migraine days."
BOTOX® prevents on average 8 to 9 headache days and migraine/probable migraine days a month (versus 6 to 7 for placebo).4 The most common side effects seen in Chronic Migraine clinical trials are neck pain, headache, migraine, slight or partial facial paralysis, eyelid drooping, bronchitis, musculoskeletal stiffness, muscle weakness, pain in one or more muscles, ligaments, tendons, or bones, muscle spasms, injection-site pain, and high blood pressure.
Those who live with Chronic Migraine but have not tried BOTOX® and are appropriate candidates are encouraged to ask their doctor if BOTOX® is right for them and if samples may be available to evaluate its efficacy and safety (sample availability may vary depending on provider or location). The BOTOX® Savings Program is also available to help eligible, commercially insured patients save on their out-of-pocket costs for BOTOX® treatment, with 95% of Chronic Migraine patients enrolled in the program paying as little as $0.* You can find more information and the program's full Terms & Conditions at BOTOXSavingsProgram.com.
About BOTOX® for Chronic Migraine
BOTOX® is the first FDA-approved preventive treatment for Chronic Migraine. Unlike acute treatments, which are taken to treat a headache or migraine once it's already begun, BOTOX® prevents headaches and migraines before they even start. It 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. Since its FDA approval a decade ago, 3.5 million BOTOX® treatments have been administered to over 550,000 Chronic Migraine patients.
About AbbVie Leadership in Migraine
AbbVie, a leader in the migraine space, markets BOTOX®, 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) for the acute treatment of migraine with or without aura in adults. UBRELVY® is not for migraine prevention. AbbVie is also advancing its migraine program with atogepant, an investigational small molecule CGRP receptor antagonist (gepant) being studied for the prevention of migraine. Atogepant is currently in Phase 3 development; the safety and efficacy has not been established.
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, another 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 (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; and 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 http://www.fda.gov/medwatch or call 1-800-FDA-1088.
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.
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.
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.
*Restrictions and maximum savings limits apply. Patient out-of-pocket expense may vary. Offer not valid for patients enrolled in Medicare, Medicaid, or other federal or state healthcare programs. Please see full terms and conditions at BOTOXSavingsProgram.com. For questions about this program, please call 1-800-44-BOTOX.
- Data on file. Allergan USA, Inc. 2019.
- Data on file. Allergan, Inc. Ubrogepant Patient ATU, 2018.
- Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders: 3rd edition. Cephalalgia. 2013;33(9):629–808.
- BOTOX® (onabotulinumtoxinA) Prescribing Information. Irvine, CA: Allergan USA, Inc. 2020.