Calcitonin gene-related peptide(Danish Headache Center)

- More patients treated with UBRELVY® 100 mg during the prodrome avoided the development of moderate or severe headache within 24 hours post-dose vs. placebo in those who could identify prodrome symptoms that were reliably followed by headache 1 - UBRELVY is the first and only acute treatment for migraine that has demonstrated data in the prodrome phase in a Phase 3, double-blind, placebo-controlled trial - AbbVie is the only company with three prescription treatments designed to meet patient needs across the full spectrum of migraine NORTH CHICAGO, Ill., Nov. 16, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced detailed results published in The Lancet evaluating the efficacy, safety, and tolerability of UBRELVY® (ubrogepant) 100 mg for the acute treatment of migraine when administered during the prodrome of a migraine attack. The Phase 3 study, PRODROME, showed that UBRELVY given during the prodrome (i.e., 1-6 hours before the predicted onset of headache pain) significantly reduced the likelihood of development of moderate or severe headache and reduced functional disability compared to placebo within 24 hours post-dose.1 The prodrome is the earliest of four phases of a migraine attack and consists of various symptoms, including sensitivity to light and/or sound, fatigue, and neck pain, that can be an early sign that the headache phase will follow.2,3 In people with migraine who experience a prodrome, symptoms can occur hours to days before the onset of headache. Treatment during the prodrome provides an opportunity to avoid the development or attenuate the severity of the headache phase of a migraine attack.4,5 "Migraine impacts nearly 40 million Americans and is a highly debilitating disease that can cause people to miss work, and time with friends and family. For patients who are able to identify prodromal symptoms, the ability to treat a migraine attack before the headache phase creates an opportunity to stop migraine attacks before they become fully debilitating," said Dawn Carlson, vice president, neuroscience development, AbbVie. "These data published in The Lancet demonstrate the important role of UBRELVY in treating migraine attacks early and reducing the overall burden of a migraine attack." During the trial, patients with migraine who could identify prodromal symptoms that led to headache at least 75% of the time (N=518), were randomly assigned to double-blind crossover treatment. Study results demonstrated the following: Absence of moderate or severe intensity headache within 24 hours was achieved following 46% of qualifying prodrome events when treated with UBRELVY vs. 29% of placebo-treated events (P<0.0001).1 Absence of moderate or severe intensity headache within 48 hours was achieved following 41% of qualifying prodrome events when treated with UBRELVY vs. 25% of placebo-treated events (P<0.0001).1 More patients had normal function within the 24 hours after treatment of qualifying prodrome events with UBRELVY than after treatment with placebo [Odds Ratio (OR) 1.66, 95% Confidence Interval (CI) 1∙40–1∙96; P<0.0001].1 Absence of headache of any intensity within 24 hours was achieved following 24% of qualifying prodrome events when treated with UBRELVY vs. 14% of placebo-treated events (P<0.0001).1 The safety population included 480 patients, and the efficacy analysis population included 477 patients.1 The most commonly reported prodrome symptoms in the study were sensitivity to light, fatigue, neck pain, sensitivity to sound and dizziness/lightheadedness.1 UBRELVY was well-tolerated with no new safety signals observed when administered during the prodrome.1 The most common side effects are nausea (UBRELVY: 5% vs. placebo: 3%), fatigue (UBRELVY: 3% vs. placebo: 2%), dizziness (UBRELVY: 2% vs. placebo: 3%), and somnolence (UBRELVY: 2% vs. placebo: 1%). "As a neurologist, I have many patients who can describe the premonitory, or prodrome, symptoms of their migraine attacks, and previously we have not had adequate data for treatment options during this earliest phase," said Peter J. Goadsby, M.D., Ph.D., FRS, neurologist and professor at King's College London. "These new data speak directly to a gap in migraine treatment and the option to use ubrogepant." About the PRODROME study PRODROME (NCT04492020) was a Phase 3, multicenter, randomized, double-blind, placebo-controlled, crossover trial that enrolled adults who experienced 2-8 migraine attacks with moderate-to-severe headache per month. Eligible patients treated 2 "qualifying prodrome events" in a crossover fashion. A qualifying prodrome event was defined as a migraine attack with prodromal symptoms in which the patient was confident a headache would follow within 1-6 hours. The primary endpoint was absence of moderate/severe intensity headache within 24 hours post-dose. Secondary endpoints were absence of moderate/severe intensity headache within 48 hours, ability to function normally over 24 hours, and absence of a headache of any intensity within 24 hours post-dose. Patients used an e-diary to record the presence and severity of symptoms at the time of each qualifying prodrome event. About UBRELVY® (ubrogepant) UBRELVY® 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 designed to directly block CGRP, a protein released during a migraine attack, from binding to its receptors. 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 for migraine prevention. IMPORTANT SAFETY INFORMATION Do not take UBRELVY if you are taking medicines known as strong CYP3A4 inhibitors, such as ketoconazole, clarithromycin, or itraconazole, or if you are allergic to UBRELVY or any of its ingredients. 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. UBRELVY may cause serious side effects, including allergic reactions. Most reactions happened within hours after taking UBRELVY and were not serious. Some reactions may occur days after taking UBRELVY. Call your healthcare provider or get emergency help right away if you have swelling of the face, mouth, tongue, or throat or trouble breathing. The most common side effects of UBRELVY are nausea (4%) and sleepiness (3%). These are not all of the possible side effects of UBRELVY. Please see UBRELVY full Prescribing Information. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more. About Migraine Migraine is a complex neurological disease with recurrent attacks that are often incapacitating and characterized by severe, throbbing headache pain as well as compounding associated symptoms like extreme sensitivity to light, sound or nausea.2 It is highly prevalent, affecting more than 1 billion people worldwide, including nearly 40 million people in the United States alone, and is the highest cause of disability worldwide for people under 50 years of age.6-9 About AbbVie in Migraine AbbVie is the only company with three prescription treatments designed to meet patient needs across the full spectrum of migraine to help patients living with this debilitating disease. At AbbVie, we are committed to empowering people living with migraine disease. 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 reduce the impact of migraine on 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 in neurological and psychiatric disorders, including bipolar I disorder, cervical dystonia, major depressive disorder, migraine, Parkinson's disease, post-stroke spasticity, schizophrenia and others, along with a robust pipeline. 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 and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube. 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 and uses of future or conditional verbs, 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 expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, 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 2022 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, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. US-UBR-230568 Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants (UBR Prodrome). ClinicalTrials.gov. Updated May 31, 2023. Accessed October 18, 2023. Headache Classification Committee of the International Headache Society. The International Classification of Headache Disorders, 3rd edition. Cephalalgia 2018; 38: 1–211. Laurell K, Artto V, Bendtsen L, et al. Premonitory symptoms in migraine: a cross-sectional study in 2714 persons. Cephalalgia 2016; 36: 951–59. Giffin NJ, Ruggiero L, Lipton RB, et al. Premonitory symptoms in migraine: an electronic diary study. Neurology 2003; 60: 935–40. Lipton RB, Pavlovic JM, Haut SR, Grosberg BM, Buse DC. Methodological issues in studying trigger factors and premonitory features of migraine. Headache 2014; 54: 1661–69. Amiri P, Kazeminasab S, Nejadghaderi SA, Mohammadinasab R, Pourfathi H, Araj-Khodaei M, Sullman MJM, Kolahi AA, Safiri S. Migraine: A Review on Its History, Global Epidemiology, Risk Factors, and Comorbidities. Front Neurol. 2022 Feb 23;12:800605. doi: 10.3389/fneur.2021.800605. PMID: 35281991; PMCID: PMC8904749. Steiner, T. J., Stovner, L. J., Vos, T., Jensen, R., & Katsarava, Z. Migraine is first cause of disability in under 50s: Will health politicians now take notice? J Headache Pain. 2018;19:17. AbbVie. Data on File: ABVRRTI73750 Katsarava Z, Buse DC, Manack AN, Lipton RB. Defining the differences between episodic migraine and chronic migraine. Curr Pain Headache Rep. 2012;16:86-92. SOURCE AbbVie

● The study marks Click’s second active randomized clinical trial testing digital interventions in migraine patients. ● The ReMMiD-C trial will evaluate the efficacy and safety of investigational digital therapeutics for the prevention of episodic migraine in patients 18 years and older receiving Calcitonin Gene-Related Peptide (CGRP) inhibitor therapy. ● Click and Syneos Health have developed a unique approach utilizing digital, decentralized clinical trial solutions to execute the study. NEW YORK--(BUSINESS WIRE)-- Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced the launch of its second active randomized clinical trial in migraine, ReMMiD-C, Reduction in Monthly Migraine Days-CGRP study, a fully remote and decentralized trial designed to investigate the efficacy and safety of digital therapeutics in reducing the number of monthly migraine days for adults diagnosed with episodic migraine currently receiving Calcitonin-Gene-Related Peptide (CGRP) inhibitor therapy. Click also recently launched the ReMMi-D study, a phase 3 pivotal registration study in approximately 558 patients, in March (NCT05853900). To execute this latest fully remote trial, Click has selected Syneos Health® (Nasdaq:SYNH), a leading fully integrated biopharmaceutical solutions organization. Together, Click and Syneos Health are designing and deploying the study, enabling patients to consent, enroll, and receive treatment remotely. The combination of Click’s digital therapeutics delivered as mobile applications and Syneos Health Decentralized Solutions delivers innovative trial design expertise to accelerate patient access, enabling patients to participate in the trial anywhere, at any time, using their own devices. This modern approach reflects the real-world potential impact and accessibility of prescription digital therapeutics “We are thrilled to join forces with Syneos Health to realize Click's visionary mission to increase access to evidence-backed therapies. Together, we are committed to pushing the boundaries of inclusivity and equity, ensuring that every individual, regardless of background or circumstance, is given a fair opportunity to participate in cutting-edge research. This groundbreaking decentralized study represents a significant step forward, empowering migraineurs who have been traditionally overlooked by clinical trials," said Shaheen Lakhan MD, PhD, FAAN, Chief Medical Officer, Click Therapeutics. Click Therapeutics received Breakthrough Device Designation (BTDD) from FDA for its migraine program in December 2022. Migraine is a complex and debilitating condition that affects more than 40 million adults,1,2 and is the second leading cause of disability in the United States.3 Migraine is characterized by episodes of moderate-to-severe headache and generally associated with nausea and increased sensitivity to light and sound.4 Its burden is impacted by employment status, poverty, education attainment and insurance coverage. Although there are a variety of pharmacologic and nonpharmacologic acute and preventative treatments available, they are not without notable limitations, and patients often do not achieve full remission in response to pharmacotherapy alone. A prescription digital therapeutic can help migraine patients access treatment, as well as give additional tools to providers treating migraine patients. “In today’s rapidly evolving clinical trial landscape, it’s imperative to design studies through the lens of accelerating patient access, improving retention and increasing diversity,” said Michael Brooks, Chief Operating Officer, Syneos Health. “We’re excited to be working with Click Therapeutics on this fully remote trial – showcasing our ability to combine fully integrated clinical, RWE and commercial insights, agile technologies and operational excellence to bring clinical trials closer to the patient. These trials maintain the same rigor as traditional clinical trials and fully support evidence generation for regulators and payers.” The phase 3, randomized, double-blind trial will enroll approximately 100 patients in the United States. Trial intervention will be delivered over 12 weeks and efficacy will be evaluated between groups as a change from baseline in the number of monthly migraine days (MDDs). The study will provide bridging data to evaluate the effectiveness of digital therapeutics for migraine in patients receiving CGRP inhibitor therapy, an emerging class of third line preventive medication for migraine such as Aimovig, Emgality, and Nurtec, as 50% of patients do not see the relief they expect from these interventions.5 This study will complement the clinical data from ReMMi-D in patients treated with first and second line preventive medications. About Click Therapeutics Click Therapeutics, Inc., develops, validates, and commercializes software as prescription medical treatments for people with unmet medical needs. As a leading innovator of Digital Therapeutics™, Click delivers accessible, clinically proven, FDA-regulated prescription treatments to the smartphone in your hand. Click’s treatments are defined by a commitment to applying technical and scientific rigor and patient-centric design to the development process. This results in uniquely engaging experiences that achieve compelling clinical outcomes for patients seeking new treatment options. Click Therapeutics continuously expands and refines its platform with novel cognitive, behavioral and neuromodulatory mechanisms of action and advanced data-driven tools such as artificial intelligence and machine learning. The digital therapeutics under development on Click’s platform address diverse areas of therapeutic need, including indications in psychiatry, neurology, oncology, immunology, and cardiometabolic diseases. Consistently named a best place to work, Click fosters an inclusive, diverse workforce of innovators, clinicians, scientists, researchers, designers, technologists, engineers and more, united in a common mission to provide patients everywhere access to safe and effective prescription digital therapeutics. For more information, visit and connect with us on LinkedIn. About Syneos Health Syneos Health® (Nasdaq:SYNH) is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. We bring together a talented team of professionals, who work across more than 110 countries, with a deep understanding of patient and physician behaviors and market dynamics. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. Syneos Health supports a diverse, equitable and inclusive culture that cares for colleagues, customers, patients, communities and the environment. To learn more about how we are Shortening the distance from lab to life®, visit syneoshealth.com or subscribe to our podcast. References 1. Stovner, L. J. & GBD 2016 Headache Collaborators. (2018). Global, regional, and national burden of migraine and tension-type headache, 1990–2016: A systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurology, 17(11), 954–976. (18)30322-3 2. James, S. L., Abate, D., Abate, K. H., Abay, S. M., Abbafati, C., Abbasi, N., … & Murray, C. J. L. (2018). Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990–2017: A systematic analysis for the Global Burden of Disease Study 2017. Lancet, 392(10159), 1789–1858. (18)32279-7 3. Burch, R., Rizzoli, P., & Loder, E. (2018). The prevalence and impact of migraine and severe headache in the United States: Figures and trends from government health studies. Headache, 58, 496–505. 4. Torres-Ferrús, M., Ursitti, F., Alpuente, A., Brunello, F., Chiappino, D., de Vries, T., … & Lampl, C. (2020). From transformation to chronification of migraine: Pathophysiological and clinical aspects. J Headache Pain, 21, 42. 5. Edvinsson, Lars, et al. "CGRP as the target of new migraine therapies—successful translation from bench to clinic." Nature Reviews Neurology 14.6 (2018): 338-350.