As Parkinson's disease progresses, patients may experience fluctuations from an "on" state to an "off state," during which they are slower, stiffer and experience more difficulty moving. Patients may also experience dyskinesias (involuntary movements).
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 medicinal products have not given satisfactory results.
The most common adverse reaction was complication of device insertion.
Most of these adverse reactions were reported early in the studies, subsequent to the percutaneous endoscopic gastrostomy procedure and occurred during the first 28 days.
Drug related undesirable effects that occur frequently with the Duodopa system include nausea and dyskinesia.
About ABBV-951
ABBV-951 is an investigational levodopa/carbidopa prodrug delivered subcutaneously being studied for the treatment of advanced Parkinson's disease.
SOURCE AbbVie
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NORTH CHICAGO, Ill., Sept. 23, 2019 /PRNewswire/ -- AbbVie (NYSE:ABBV), a research-based global biopharmaceutical company, today announced experts in the neuroscience field will present results from two late-breaking abstracts, including final data from the Phase 1b study evaluating the safety and tolerability of the investigational medicine ABBV-951 in patients with advanced Parkinson's disease (PD), and data from the real-world DUOGLOBE study, evaluating the effect of DUODOPA® (levodopa/carbidopa intestinal gel) in patients with advanced Parkinson's disease. In total, 22 abstracts featuring new and updated data evaluating AbbVie's neuroscience portfolio and pipeline will be presented at the 2019 International Congress of Parkinson's Disease and Movement Disorders®, September 22-26 in Nice, France.
The Phase 1b study evaluating ABBV-951 was designed to determine the safety and tolerability of ABBV-951, an investigational solution of levodopa/carbidopa delivered through continuous subcutaneous infusion (CSCI) in patients with advanced Parkinson's disease. A Phase 3 study evaluating the safety and tolerability of ABBV-951 (NCT-03781167) CSCI over 24 hours per day is currently enrolling patients. The design of the Phase 3 study will be presented as a poster at the congress.
The multinational, real-world observational study, DUOGLOBE, was designed to evaluate the effect of DUODOPA on motor symptoms/motor complications (including "off" time and dyskinesia), quality of life (QoL) and caregiver burden, in patients with advanced PD who were treated with DUODOPA in routine clinical practice. 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 medicinal products have not given satisfactory results.
"Our research presented at the congress demonstrates our longstanding commitment to developing and delivering science that will make a difference in the lives of people with Parkinson's disease and other neurodegenerative conditions," said Michael Gold, M.D., vice president, neuroscience development, AbbVie. "We are excited to share this latest data with leading researchers around the world as we take a few steps closer to potentially providing patients with much needed additional treatment options."
Other data presentations include the pharmacokinetics of ABBV-951, the impact of progressive supranuclear palsy (PSP) on healthcare resource utilization and PSP caregivers, and several studies examining DUODOPA in advanced PD patients in a variety of clinical and real-world settings, including its impact on motor symptoms when using wearable sensors, its utilization in patients being treated with add-on therapies, and in patients with non-motor symptoms. Abstracts demonstrating the prevalence, impact and burden of PD will also be presented.
About Parkinson's Disease
More than 6 million people worldwide are living with Parkinson's disease, a progressive and chronic movement disorder1 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.1 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.3 While there is no known cure for the disease, there are treatments available to help reduce symptoms.3
About Progressive Supranuclear Palsy
Progressive supranuclear palsy (also known as Steele-Richardson-Olszewski syndrome) is a progressive neurodegenerative disorder, with an estimated worldwide annual prevalence of three to six per 100,000 people.4 The average onset of PSP symptoms typically begins after age 60. The most common features of PSP are loss of balance leading to unexplained falls, blurred vision, problems controlling eye movement and slurred speech. Other nonspecific symptoms of PSP, such as slowed movements or behavioral or cognitive changes, are similar to other brain disorders, particularly Parkinson's disease. For this reason, correct diagnosis of PSP is often delayed. The course of PSP is progressive and may predispose individuals to serious complications, such as choking, pneumonia, head injury and fractures caused by falls. Currently, there are no approved treatments for PSP.4
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 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, post procedural haemorrhage.
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.
About AbbVie in Neuroscience
At AbbVie, our commitment to addressing the needs of people living with neurodegenerative disease is unwavering. Every challenge in this uncharted territory makes us more determined and drives us harder to discover and deliver solutions for patients, caregivers and clinicians. AbbVie's Neuroscience portfolio consists of approved therapies and a robust pipeline in neurodegenerative diseases, including Alzheimer's disease, Parkinson's disease and multiple sclerosis. 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 is yielding a deeper understanding of the pathophysiology of neurodegenerative 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.
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.
