Opicapone (Ongentys): A New COMT Inhibitor for the Treatment of Parkinson's Disease

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.

Automated summary

Opicapone, a newly FDA-approved COMT inhibitor, has shown to be safe and effective in reducing off episodes in PD patients when used as an adjunct to levodopa/carbidopa. Preclinical trials demonstrated marked S-COMT inhibition with acceptable safety and efficacy profile, while phase 3 clinical trials supported its efficacy compared to placebo and noninferiority to entacapone. Common adverse effects include dyskinesias, constipation, hypotension/syncope, increased blood creatine kinase, and weight loss.