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ATLANTA, Oct. 8 /PRNewswire/ -- UCB, Inc. presented data from two clinicaltrials that showed Neupro(R) (Rotigotine Transdermal System), a once-dailynon-ergolinic dopamine agonist patch, is effective in controlling earlymorning motor impairment, provides improvement in sleep quality, and isgenerally well-tolerated for long-term use in patients with Parkinson'sdisease. Studies examining patients who have either early or advanced-stageParkinson's disease were also presented.
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"Neupro offers continuous delivery of a dopamine agonist for 24 hours,leading to stable plasma levels," said Rajesh Pahwa, M.D., Professor ofNeurology and Director of the Parkinson Disease and Movement Disorder Centerat the University of Kansas Medical Center. "These data showed that Neuprohas a positive effect on patients' early morning symptoms, improves quality ofsleep, and is generally well-tolerated for long-term use in patients withParkinson's disease." Dr. Pahwa is an investigator for the long-term, open-label study.
An open-label, single-arm, exploratory 18-week study investigated theefficacy of Neupro(R) on early morning motor impairment and sleep disorders.Fifty-four patients with mostly advanced-stage Parkinson's disease andunsatisfactory control of these symptoms received Neupro(R) in doses from 4 to16 mg/24 hours during a 4-week maintenance period. Motor improvement uponwaking and changes in sleep disturbances were assessed.
Forty-nine percent of patients treated per protocol with Neupro(R) showedconsiderable improvement in early morning motor function sufficient to meetresponse criteria (greater than or equal to 30% improvement of UPDRS IIIscore). Nocturnal akinesia -- inability to move at night -- was reduced by56%, and improvement was also noted in nocturnal dystonia -- painful musclecontraction -- and cramps. Neupro(R) improved sleep quality, reducedexcessive daytime sleepiness, decreased night-time urinary symptoms(nocturias), and appeared generally well-tolerated. The most frequentlyreported adverse events in patients treated with Neupro(R) were applicationsite reactions (20%), nausea (19%), and somnolence (11%).
Additionally, new, interim safety data from a four-year, open-labelextension of a separate pivotal Phase III, double-blind clinical trial werepresented. These data, in 216 patients with early-stage Parkinson's disease,showed Neupro(R) was generally well-tolerated at 33 months of treatment.Patients were tapered to their Neupro(R) starting dose and re-titrated over a3-week period. Neupro(R) doses were limited to less than or equal to 6 mg/24hours the first year, after which doses less than or equal to 16 mg/24 hourswere allowed.
The majority of participants (73%) remained in the study at 33 months,with few discontinuations related to adverse events (13%) and a low incidenceof dyskinesia (6.5%). The most frequently reported adverse events amongpatients treated with Neupro(R) 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 thebenefits of Neupro in patients with early and advanced-stage Parkinson'sdisease," said Iris Loew-Friedrich, MD, PhD, Global Head of Development, UCB."
