Objective: To describe the safety and efficacy of opicapone, a newly Food and Drug Administration-approved catechol-O-methyltransferase (COMT) inhibitor, as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease (PD) experiencing off episodes.
Data sources: A literature search through PubMed and International Pharmaceutical Abstracts (January 2000 to October 2020) was conducted using the following search terms: Ongentys, opicapone, COMT inhibitor, Parkinson's disease, and Parkinson's.
Study selection and data extraction: Articles selected included those describing preclinical and clinical studies examining the pharmacokinetics, efficacy, and/or safety of opicapone.
Data synthesis: In preclinical trials, opicapone demonstrated marked S-COMT inhibition, despite its short half-life, while maintaining an acceptable safety and efficacy profile. Results from phase 3 clinical trials further supported the safety and efficacy of opicapone as an adjunct to levodopa. In addition, opicapone, at a dose of 50 mg once daily, was shown to be superior to placebo and noninferior to entacapone in reducing time spent in the off state. Adverse effects commonly reported with opicapone include dyskinesias, constipation, hypotension/syncope, increased blood creatine kinase, and decreased weight.
Relevance to patient care and clinical practice: Additional medications, such as COMT inhibitors, become necessary adjunctive treatments as the disease progresses. Compared to other COMT inhibitors currently on the US market, opicapone offers the advantage of once-daily dosing.
Conclusion: Opicapone is a safe and effective COMT inhibitor shown to reduce off episodes in patients with PD.
Keywords: COMT inhibitor; Parkinson’s; Parkinson’s disease; opicapone; treatment.