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 Neupro(R) was generally well-tolerated at 33 months of treatment. Patients were tapered to their Neupro(R) starting dose and re-titrated over a 3-week period. Neupro(R) doses were limited to <6 mg/24 hours the first year, after which doses <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 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 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."
Neupro(R), 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. Neupro(R) is designed to mimic
the action of dopamine, a naturally-produced neurotransmitter crucial for
proper motor functioning. The system is ap
|SOURCE UCB, Inc.|
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