Objective: To provide a drug review of the newly FDA approved catechol-O-methyl transferase (COMT) inhibitor, opicapone, for the use of end-of-motor motor fluctuation in adults with Parkinson's disease. Data sources: A literature search of Pubmed was performed till May 2020 using the following key terms: opicapone, Ongentys, and BIA 9-1067. Review articles, clinical trials, and drug monographs were reviewed. Study selection and data extraction: Relevant English-language monographs and studies conducted in humans were considered. Data synthesis: Opicapone was FDA approved for the treatment of end-of-motor motor fluctuation in adults with Parkinson's disease in April 2020 based on two published randomized clinical trials that were 14 to 15 weeks in duration called BIPARK I and BIPARK II. Based on the clinical trials, 50 mg of opicapone once daily was shown to be noninferior to entacapone and reduced the mean off time by about 50 min when compared to placebo. Most common treatment-emergent adverse events were dyskinesia, falls, insomnia, and elevated blood creatine phosphokinase levels. Relevance to patient care and clinical practice: Opicapone overcomes the limitations associated with other COMT inhibitors since it is dosed once daily, well tolerated, and has not been associated with the risk of hepatic failure. When switching from entacapone to opicapone a reduction in "off" time of -39.3 min was also seen. Conclusions: Opicapone is a once daily 3rd generation COMT inhibitor that has the potential to benefit patients with Parkinson's disease who are experiencing end-of-motor fluctuations.
Keywords: COMT inhibitor; Opicapone; Parkinson’s Disease.
© 2020 Published by Elsevier Ltd.