Healthcare Industry News: daytime sleepiness
News Release - October 8, 2007
Neupro(R) (Rotigotine Transdermal System) Effective in Controlling Early Morning Motor Impairment and Generally Well-Tolerated for Long-Term Use in Patients with Parkinson's DiseaseData Presented at the 132nd Annual Meeting of the American Neurological Association in Washington, D.C.
ATLANTA, Oct. 8 (HSMN NewsFeed) -- UCB, Inc. presented data from two clinical trials that showed NeuproŽ (Rotigotine Transdermal System), a once-daily non-ergolinic dopamine agonist patch, is effective in controlling early morning motor impairment, provides improvement in sleep quality, and is generally well-tolerated for long-term use in patients with Parkinson's disease. Studies examining patients who have either early or advanced-stage Parkinson's disease were also presented.
"Neupro offers continuous delivery of a dopamine agonist for 24 hours, leading to stable plasma levels," said Rajesh Pahwa, M.D., Professor of Neurology and Director of the Parkinson Disease and Movement Disorder Center at the University of Kansas Medical Center. "These data showed that Neupro has a positive effect on patients' early morning symptoms, improves quality of sleep, and is generally well-tolerated for long-term use in patients with Parkinson's disease." Dr. Pahwa is an investigator for the long-term, open- label study.
An open-label, single-arm, exploratory 18-week study investigated the efficacy of NeuproŽ on early morning motor impairment and sleep disorders. Fifty-four patients with mostly advanced-stage Parkinson's disease and unsatisfactory control of these symptoms received NeuproŽ in doses from 4 to 16 mg/24 hours during a 4-week maintenance period. Motor improvement upon waking and changes in sleep disturbances were assessed.
Forty-nine percent of patients treated per protocol with NeuproŽ showed considerable improvement in early morning motor function sufficient to meet response criteria (greater than or equal to 30% improvement of UPDRS III score). Nocturnal akinesia -- inability to move at night -- was reduced by 56%, and improvement was also noted in nocturnal dystonia -- painful muscle contraction -- and cramps. NeuproŽ improved sleep quality, reduced excessive daytime sleepiness, decreased night-time urinary symptoms (nocturias), and appeared generally well-tolerated. The most frequently reported adverse events in patients treated with NeuproŽ were application site reactions (20%), nausea (19%), and somnolence (11%).
Additionally, new, interim safety data from a four-year, open-label extension of a separate pivotal Phase III, double-blind clinical trial were presented. These data, in 216 patients with early-stage Parkinson's disease, showed NeuproŽ was generally well-tolerated at 33 months of treatment. Patients were tapered to their NeuproŽ starting dose and re-titrated over a 3-week period. NeuproŽ doses were limited to less than or equal to 6 mg/24 hours the first year, after which doses less than or equal to 16 mg/24 hours were allowed.
The majority of participants (73%) remained in the study at 33 months, with few discontinuations related to adverse events (13%) and a low incidence of dyskinesia (6.5%). The most frequently reported adverse events among patients treated with NeuproŽ in this trial were somnolence (41%), application site reactions (23%), most of which were rated as mild (95%), nausea (18%) and dizziness (20%).
"We are pleased to present important data which help demonstrate the benefits of Neupro in patients with early and advanced-stage Parkinson's disease," said Iris Loew-Friedrich, MD, PhD, Global Head of Development, UCB. "We look forward to continuing the Neupro clinical development program and are working to make this unique therapy available for U.S. patients with advanced stages of the disease."
NeuproŽ, with the active ingredient rotigotine, is a non-ergolinic dopamine receptor-agonist formulated as a transdermal delivery system, a patch, designed for once-a-day application. NeuproŽ is designed to mimic the action of dopamine, a naturally-produced neurotransmitter crucial for proper motor functioning. The system is applied to the skin once a day and provides rotigotine continuously to the body for 24 hours. Patients receiving NeuproŽ initiate treatment with a 2 mg/24 hours patch and titrate in 2 mg/24 hours increments each week until the optimal effect is observed, up to a maximum dose of 6 mg/24 hours. The administration of NeuproŽ offers simple, once-daily dosing, and it is easy to use.
NeuproŽ is approved in the United States for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease, and in Europe for the treatment of patients with early Parkinson's disease and in combination with levodopa for advanced Parkinson's disease.
About Parkinson's Disease
Parkinson's disease is a progressive disorder of the central nervous system. The patients -- roughly four million worldwide, including approximately one million people in the United States -- suffer primarily from a lack of dopamine, a messenger substance in the central nervous system, which is responsible for the coordination of movement. As a result of this shortage, patients are no longer able to control their movements reliably. Dopamine agonists are drugs that attempt to compensate for this lack of dopamine.
Important Safety Information
NeuproŽ is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease. Some patients treated with NeuproŽ reported falling asleep while engaged in activities of daily living, including operation of motor vehicles, which sometimes resulted in accidents. Some patients perceived no warning signs, such as excessive drowsiness. Hallucinations were reported in 2.0% of patients treated with NeuproŽ compared to 0.7% of patients on placebo. NeuproŽ should be used with caution in patients, especially those at risk for cardiovascular disease, because of the potential for symptomatic hypotension, syncope, elevated heart rate, elevated blood pressure, fluid retention, and/or weight gain. All Parkinson's disease patients are at a higher risk for melanoma and should be monitored regularly. The most commonly reported side effects in clinical trials were nausea, application site reactions, somnolence, dizziness, headache, vomiting, and insomnia. Some subjects who received NeuproŽ experienced a decline in blood hemoglobin levels (about 2% relative to subjects who received placebo). It is not known whether this change is readily reversible with discontinuation of NeuproŽ. For full prescribing information, please visit www.neupro.com.
UCB, Brussels, Belgium (www.ucb-group.com) is a global leader in the biopharmaceutical industry dedicated to the research, development and commercialisation of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diseases, immune and inflammatory disorders and oncology -- UCB focuses on securing a leading position in severe disease categories. Employing more than 10,000 people in over 40 countries, UCB achieved revenue of 3.5 billion euro in 2006 on a pro forma basis. UCB is listed on the Euronext Brussels Exchange and owns approximately 88% of the shares of SCHWARZ PHARMA AG. SCHWARZ PHARMA AG (Monheim, Germany) is a member of UCB Group.
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