BIAL’s opicapone significantly improves OFF-time in fluctuating Parkinson’s

Privately-held Portuguese drugmaker BIAL today announced positive results from a Phase III, randomized, double-blind, active- and placebo-controlled, parallel group study (BIPARK-I) evaluating opicapone (BIA 9-1067), a novel once-daily catechol-O-methyltransferase (COMT) inhibitor for use as adjunctive therapy in levodopa-treated Parkinson’s disease patients.

In the study, opicapone 50mg once-daily achieved significant reductions (2.0 hours) in absolute OFF-time (p=0.0005 versus 0.9 hours for placebo). Significant improvements were also observed in Investigators’ and Subjects’ Global Assessment of Change. The improvement tendency was significant compared to placebo (p=0.0005, p=0.0008) and also entacapone (p=0.007, p=0.0091), respectively. Opicapone was considered overall safe and well tolerated.

Detailed study results were presented today during a poster session at the 12th International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders (AD/PD2015) in Nice, France.