First presentation of data from NEUPRO (rotigotine transdermal patch) Phase 3 study in China announced

UCB has announced efficacy and safety data from a Phase 3 study evaluating NEUPRO® (rotigotine transdermal patch) in the treatment of patients in China with early-stage Parkinson’s disease (PD).1 Results showed that rotigotine significantly improved activities of daily living and motor function compared with placebo. The adverse event profile observed in this population was consistent with that known for rotigotine.2 The data were presented this week at the 19th International Congress of Parkinson’s Disease and Movement Disorders (MDS) in San Diego, June 14-18, 2015.

“In this Phase 3 study, transdermally delivered rotigotine resulted in significant benefits in control of activities of daily living as well as motor symptoms in patients with early-stage Parkinson’s disease and also resulted in a greater number of responders compared with placebo. The adverse event profile was similar to that seen in rotigotine studies in the previously studied Caucasian population.” said Professor Zhang, MD, from Peking Union Medical College Hospital, Beijing, China.

This Phase 3, multicenter, randomized, double-blind, placebo-controlled study conducted in China, was designed to evaluate the efficacy and safety of rotigotine (2-8 mg/24 hours) in 247 adult patients (mean age of 59.4 years ± 10.2 SD) with early-stage idiopathic PD over 24 weeks of treatment after patients reached their optimal dose. The primary efficacy variable was the change over the course of treatment in the total score of the activities of daily living (ADL) section and motor examination section of the Unified Parkinson’s Disease Rating Scale (UPDRS). Secondary variables included patients’ response to therapy defined as 20% or more improvement in the UPDRS ADL and motor examination sections total score (20% responder rates).1

Efficacy Results1

• Rotigotine significantly improved the UPDRS ADL and motor examination total score compared with placebo (p<0.0001). The mean (±SD) change from baseline was -4.9 (±9.9) for rotigotine (n=123) vs. -0.2 (±9.9) for placebo (n=121).
• Both the individual ADL and motor examination subscores also improved with rotigotine compared with placebo (p<0.0001, and p=0.0004, respectively).
• The 20% responder rates were higher with rotigotine vs. placebo (42.3% vs. 22.3%).

Safety/Tolerability Results1

• The most commonly reported adverse events for the rotigotine (n=124) and placebo (n=123) groups were nausea (8.9% rotigotine vs. 3.3% placebo), dizziness (8.1% vs. 5.7%), pruritus (8.1% vs. 4.1%), somnolence (8.1% vs. 3.3%), erythema (6.5% vs. 1.6%), and vomiting (5.6% vs. 1.6%).
• Overall, 5.3% patients discontinued due to adverse events (4.8% rotigotine vs. 5.7% placebo).

NEUPRO is currently available as a treatment for Parkinson’s disease in over 46 countries worldwide, including the US, the European Union and Japan. NEUPRO is not approved in China for the treatment of Parkinson’s disease. UCB plans to submit a regulatory application in China in 2015 for NEUPRO in Parkinson’s disease.

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References

1. Zhang Z et al. Efficacy and safety of rotigotine transdermal patch in Chinese patients with early-stage Parkinson’s disease: a randomized, double-blind, placebo-controlled study. Presented at the 19th International Congress of Parkinson’s Disease and Movement Disorders, San Diego, U.S. June 14-18, 2015.