ABSTRACT
Introduction: Opicapone is a novel, third generation COMT inhibitor approved for the treatment of Parkinson’s disease. Safety and tolerability data is critical to determine the benefit-harm balance and anticipate therapeutic adherence.
Areas covered: This review evaluates the tolerability and safety profile of opicapone. These data were extracted from all published clinical trials, including preclinical, phase I, phase II and phase III studies as well as postmarketing data. Opicapone was safe and well tolerated, with frequencies of treatment-emergent adverse events similar to placebo.
Expert opinion: Opicapone have shown a good safety and tolerability profile. This adds to its proven efficacy and convenient once-daily administration, supporting a role of opicapone as a first-line therapy for motor complications in Parkinson’s disease patients.
Declaration of interest
AC Caldas has received educational and travel grants from BIAL, Biogen, Novartis, Medtronic and St. Jude Medical. T Teodoro receives funding from ‘Fundação para a Ciência e Tecnologia’ (SFRH/SINTD/95267/2013) and has received travel and educational grants from BIAL, Ipsen, Boston Scientific and Novartis. J Ferreira has held consultancy functions with GlaxoSmithKline, Novartis, Teva, Lundbeck, Solvay, Abbott, BIAL, Merck-Serono, Merz, Ipsen, and Biogen; has received lecture fees from Biogen and BIAL; has received grants from GlaxoSmithKline, Grünenthal, MSD, Allergan, Novartis, Fundação MSD (Portugal), and Teva; and has been employed by Centro Faculdade de Medicina de Lisboa and CNS – Campus Neurológico Sénior. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.