Objective: This exploratory post-hoc analysis evaluated the efficacy and safety of opicapone (OPC) as first-line adjunctive therapy in levodopa/DOPA decarboxylase inhibitors-treated Parkinson’s disease (PD) patients with end-of-dose motor fluctuations.

Background: OPC, a once-daily catechol-O-methyltransferase inhibitor, proved effective in treating motor fluctuations in PD patients in two large multinational trials (BIPARK-I and II) [1,2].

Method: Data from matching treatment arms in BIPARK-I and II were combined in placebo (PLC) and OPC 50 mg groups for patients treated with levodopa-only at baseline (i.e. without dopamine agonists [DAs] or monoamine oxidase-B inhibitors [MAOBIs]). Studies had similar designs and eligibility criteria [1,2]. Statistical analysis of efficacy was performed using Analysis of Covariance.

Results: At baseline, 59 and 68 were treated with levodopa-only in the PLC and OPC 50 mg groups, respectively (Table 1). Changes from baseline in absolute OFF- and ON-time were significantly greater for OPC 50 mg versus PLC (p=0.0161 and p=0.0049, respectively; Table 2). The most frequently reported at least possibly related treatment-emergent adverse events (TEAEs) (>/=5% patients) were dyskinesia, constipation and nausea (Table 3). The incidence of at least possibly related TEAEs leading to discontinuation was similar in both arms (Table 3).

Conclusion: OPC 50 mg demonstrated efficacy and was generally well tolerated in PD patients treated with levodopa-only, suggesting that OPC is a viable option as a first-line adjunctive therapy in levodopa-treated PD patients with motor fluctuations.

References: 1. Ferreira et al., Lancet Neurol. 2016;15(2):154-165. 2. Lees et al., JAMA Neurol. 2017;74(2):197-206.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/opicapone-as-first-line-adjunctive-levodopa-treatment-in-parkinsons-disease-patients-with-motor-fluctuations-findings-from-bipark-i-and-ii-combined-post-hoc-analysis/