AbbVie to Present New Data From 15 Abstracts at the 2020 Virtual Migraine Trust International Symposium
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
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)
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)
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
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®:
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.
IMPORTANT SAFETY INFORMATION
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:
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®?
What is UBRELVY® (ubrogepant)?
Please see full Prescribing Information.
About UBRELVY® (ubrogepant)
About AbbVie in Neuroscience
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.
Company Codes: NYSE:ABBV