UCB's Neupro effective for motor impairment in PD

Belgian drugmaker UCB says that clinical data shows that Neupro (rotigotine transdermal system), its once-daily non-ergolinic dopamine agonist patch, effectively treats the early morning motor impairment associated with Parkinson's disease. The results also demonstrated that the product provides PD sufferers with improved sleep quality.

The findings, which were presented at this year's meeting of the American Neurological Association's meeting in Washington DC, are from two assessments of the product in PD patients. The first study, an open-label, single-arm 18-week examination that recruited 54 patients with advanced disease, showed that treatment improved early morning motor impairment in 49% of subjects according to UPDRS III criteria. Specifically, Neupro reduced the level of nocturnal akinesia suffered by around 56% of patients, brought about improvement in nocturnal dystonia and reduced the occurrence of daytime sleepiness.

In addition, four-year safety data from an open-label extension of a previously-reported Phase III study (Marketletters passim), indicated that the product was safe and well-tolerated for periods of 33 months. Of the 73% of subjects who continued into the extension trial, 13% subsequently dropped out due to adverse events, with 6.5% of patients leaving the program as a result of dyskinesia. Most commonly reported adverse events included: somnolence (41%); application site reactions (23%); nausea (18%); and dizziness (20%).