NORTH CHICAGO, Ill., Sept. 11, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced it will present results from several studies, including the DYSCOVER study evaluating the efficacy of DUODOPA® (levodopa/carbidopa intestinal gel) on the duration and severity of dyskinesia in patients with advanced Parkinson's disease (PD), at the 2020 International Congress of Parkinson's Disease and Movement Disorders® Virtual Congress, September 12-16. In total, 18 abstracts will be presented, including an overview of the pivotal Phase 3 study design for the investigational medicine ABBV-951 in patients with advanced PD, several studies evaluating the economic burden of PD, as well new and updated data evaluating AbbVie's neuroscience portfolio and pipeline.
The 12-week DYSCOVER study is the first randomized clinical trial comparing the efficacy of DUODOPA to optimized medical treatment (OMT) on dyskinesia in advanced PD patients using the Unified Dyskinesia Rating Scale (UDysRS), which measures all aspects of dyskinesia with a comprehensive score as the primary endpoint.
The study design for the multi-country, open-label, single arm, 52-week pivotal phase 3 study of ABBV-951 (foscarbidopa/foslevodopa), a subcutaneous delivery of levodopa/carbidopa being investigated for the treatment of advanced PD, will also be presented. The study is evaluating the local and systemic safety and tolerability of ABBV-951 delivered as a continuous, all-day subcutaneous infusion via an external pump for up to 52 weeks in people with advanced PD. The study is in process and estimated to conclude in late 2021.
"At AbbVie, we are resolute in our commitment to address the unmet needs of people living with neurologic diseases through new and innovative solutions," said Michael Gold, MD, Vice President, Neuroscience Development. "In the face of uncertainty and the unknown, we are determined to preserve personhood. We look forward to participating in the MDS 2020 Virtual Congress and sharing our latest research with scientists and healthcare professionals from around the globe."
Other data presentations include analyses from several DUODOPA-related studies, including the COSMOS Observational Study, a multi-country, cross-sectional, retrospective, post-marketing observational study that enrolled patients with advanced PD who were treated with DUODOPA for more than 12 months. Also being presented are analyses from the DUOGLOBE study, a three-year global, multicenter, single-arm, non-interventional post-marketing observational study of patients with advanced PD treated with DUODOPA.
Additionally, abstracts demonstrating the prevalence, impact and economic burden of PD will be presented.
About Parkinson's Disease
More than 10 million people worldwide are living with Parkinson's disease1, a progressive and chronic movement disorder characterized by tremor, muscle rigidity, slowness of movement and difficulty with balance.2 It is classified as a movement disorder resulting from the loss of dopamine-producing brain cells.3 The motor symptoms of Parkinson's disease begin when approximately 60-80 percent of the dopamine-producing cells in the brain are lost and symptoms continue to worsen slowly over the course of time.4 While there is no known cure for the disease, there are treatments available to help reduce symptoms.5
As Parkinson's disease progresses, patients can experience fluctuations from an "on state" to an "off state," during which they are slower and stiffer and experience more difficulty moving. Patients can also experience dyskinesias (involuntary movements). Dyskinesia is among the most troublesome symptoms of the disease with approximately 50 percent of patients presenting with dyskinesia four to five years after initiation of treatment and approximately 90 percent of patients presenting with dyskinesia after nine years.6
DUODOPA® (levodopa/carbidopa intestinal gel) EU Indication
DUODOPA is indicated for the treatment of advanced levodopa-responsive Parkinson's disease with severe motor fluctuations and hyperkinesia or dyskinesia when available combinations of Parkinson's medicinal products have not given satisfactory results.
Important DUODOPA EU Safety Information
DUODOPA is contraindicated in patients with hypersensitivity to levodopa, carbidopa or any of the excipients, narrow-angle glaucoma, severe heart failure, severe cardiac arrhythmia, acute stroke, selective type A inhibitors and nonselective MAO inhibitors, conditions contraindicated for adrenergics (e.g. pheochromocytoma, hyperthyroidism, and Cushing's syndrome), and suspicious skin lesions or history of melanoma.
Some warnings and precautions include the following: device and procedure-related complications, sudden onset of sleep: caution should be exercised when driving and operating machines. Caution in: severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease, or history of peptic ulcer disease or of convulsions. Risk of symptoms resembling Neuroleptic Malignant Syndrome following abrupt dose reduction or discontinuation. Monitor all patients for the development of mental changes, depression with suicidal tendencies, and other serious mental changes. Caution in chronic wide-angle glaucoma; monitor for intra-ocular pressure changes. Patients with past or current psychosis should be treated with caution. Monitor patients regularly for the development of impulse control disorders, for example Dopamine Dysregulation Syndrome (DDS). Periodic evaluation of hepatic, haematopoietic, cardiovascular and renal function is recommended during extended therapy with DUODOPA. Patients with Parkinson's disease have a higher risk of developing melanoma. Monitor patients for melanomas on a regular basis when using DUODOPA. DUODOPA is not recommended during pregnancy. Breast-feeding should be discontinued during treatment with DUODOPA.
The most common adverse reaction was complication of device insertion.
The very common (≥ 10%) and common (≥1% to < 10%) device and procedure-related adverse reactions reported in clinical trials included abdominal discomfort, abdominal pain, peritonitis, pneumoperitoneum postoperative wound infection, incisional cellulitis, excessive granulation tissue, device dislocation, device occlusion, complications of device insertion, incision site erythema, post-procedural discharge, stoma complication, incision site pain, postoperative Ileus, post-procedural complication, post-procedural discomfort and post-procedural hemorrhage.
Most of these adverse reactions were reported early in the studies, subsequent to the percutaneous endoscopic gastrostomy procedure, occurring during the first 28 days.
Drug-related undesirable effects that occur frequently with the DUODOPA system include nausea and dyskinesia.
This is not a complete summary of all safety information. See DUODOPA full summary of product characteristics (SmPC) at www.ema.europa.eu. Globally, prescribing information varies; refer to the individual country product label for complete information.
ABBV-951 is a subcutaneous delivery of levodopa/carbidopa being investigated for the treatment of advanced Parkinson's disease.
About AbbVie in Neuroscience
At AbbVie, our commitment to preserve the personhood of those living with neurologic 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 and a robust pipeline in neurologic and psychiatric disorders, including Alzheimer's disease, bipolar disorder and depression, major depressive disorder, migraine, multiple sclerosis, Parkinson's disease, post-stroke spasticity, schizophrenia, and stroke.
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 perseverance in these challenging therapeutic areas is yielding a deeper understanding of the pathophysiology of neurologic diseases, 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.
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.
1 Parkinson's Foundation. https://www.parkinson.org/Understanding-Parkinsons/Statistics#:~:text=More%20than%2010%20million%20people Accessed August 27, 2020.
2 The Michael J. Fox Foundation for Parkinson's Research. https://www.michaeljfox.org/understanding-parkinsons/i-have-got-what.php#q2 Accessed August 27, 2020.
3 The Michael J. Fox Foundation for Parkinson's Research. https://www.michaeljfox.org/understanding-parkinsons/i-have-got-what.php#q2 Accessed August 27, 2020.
4 National Institute of Neurological Disorders and Stroke. https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Hope-Through-Research/Parkinsons-Disease-Hope-Through-Research. Accessed August 27, 2020.
5 National Institute of Neurological Disorders and Stroke. https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Hope-Through-Research/Parkinsons-Disease-Hope-Through-Research. Accessed August 27, 2020.
6 Van Laar T. CNS Drugs. 2003;17:475-489.