Opicapone 50mg capsules

Opicapone, a once-daily catechol-O-methyltransferase (COMT) inhibitor, is used as an add-on to levodopa treatment to manage motor fluctuations in Parkinson’s Disease (PD). Although its efficacy in extending ON time is established, the safety profile of opicapone, particularly regarding adverse events and dyskinesia, remains under investigation. A systematic review and meta-analysis were performed with randomized controlled trials (RCTs) and open-label trials that investigated the incidence of adverse events in individuals with PD treated with opicapone as an add-on to levodopa treatment. The systematic search was conducted in PubMed, Cochrane, and EBSCO Megafile databases. Random-effects meta-analyses calculated risk ratios (RR) for adverse events, serious adverse events, adverse events leading to discontinuation, and dyskinesia. Certainty of evidence was assessed using the Cochrane Grading Recommendations Assessment, Development and Evaluation approach. Six studies (n = 2705) were included, with four RCTs eligible for meta-analysis. Opicapone at both 25 mg and 50 mg doses was associated with a significantly increased risk of dyskinesia compared to placebo (25 mg: RR = 2.47; 50 mg: RR = 2.75). No statistically significant differences were found for overall adverse events, serious adverse events, or adverse events leading to discontinuation. Heterogeneity across studies was generally low. Opicapone, as an add-on to levodopa treatment, shows a favorable overall safety profile, with the primary concern being an increased incidence of dyskinesia. Clinicians should monitor for motor complications and adjust levodopa dosing as needed. Further research is needed to refine dyskinesia management strategies and evaluate long-term safety outcomes.

Abstract licence: CC BY 4.0

Background: In recent times, the US-FDA approved istradefylline and opicapone as an adjunct to levodopa/carbidopa for managing the "off" episodes in Parkinson’s disease. Purpose: Current meta-analysis was performed to determine the safety and efficacy of these drugs in the management of “off” episodes and to recognize which among them would provide therapeutic benefits clinically. Methods: A thorough literature search was performed through the Cochrane Library, PubMed, and clinicaltrials.gov for a period from January 2003 to October 2020, with the following keywords: Istradefylline, KW-6002, opicapone, BIA 9-1067, and Parkinson’s disease. Those randomized, double-blind placebo/active comparator-controlled trials that analyzed the efficacy and safety of istradefylline and opicapone and that were published in the English language were included. In this analysis, the outcomes focused on the least square mean change in “off” time and Unified Parkinson’s Disability Rating Scale (UPDRS) III score from baseline to the end of the study, and the incidence of treatment-emergent adverse events (TEAEs) and dyskinesia. Results: Both drugs have shown significant reduction in “off” time duration (mean difference [MD] = –0.70; 95% CI [–1.11, –0.30]; P < 0.001 for istradefylline and MD = –0.85; 95% CI [–1.09, –0.61]; P < .001 for opicapone). Istradefylline showed significant improvement in UPDRS III (MD = –1.56; 95% CI [–2.71, –0.40]; P < .008), but the same was not observed with opicapone (MD = –0.63; 95% CI [–1.42, –0.15]; P < .12). The incidence of TEAEs and dyskinesia reportedly were higher in the intervention group rather than with the placebo, (risk ratio RR =1.11, 95% CI [1.02,1.20] for istradefylline and RR =1.12, 95% CI [1.00,1.25] for opicapone, and for dyskinesia particularly, the incidence was higher with opicapone as compared to istradefylline (RR = 3.47, 95% CI [2.17, 5.57], and RR = 1.77, 95% CI [1.29, 2.44], respectively). Conclusions: Both drugs were comparable in efficacy; however, istradefylline seemed to be better in reducing the UPDRS III score. Although the incidence of TEAEs and dyskinesia were higher with both the drugs, the incidence of dyskinesia was more in the opicapone group.

Abstract licence: CC BY-NC 4.0

Background: In levodopa‐treated individuals with Parkinson’s disease (PD) and end‐of‐dose motor fluctuations, the BIPARK‐I randomized controlled trial (RCT) demonstrated that opicapone is noninferior to entacapone in reducing OFF‐time. Furthermore, the BIPARK‐II RCT demonstrated that opicapone is well tolerated and significantly reduces OFF‐time compared with placebo. This study developed a cost‐effectiveness model (CEM) of opicapone compared with entacapone from the perspective of the English National Health Service (NHS) and personal social services (PSS).

Abstract licence: CC BY 4.0

ABSTRACT Background Levodopa‐carbidopa intestinal gel infusion (LCIG) is an effective therapy for advanced Parkinson's disease (PD). Opicapone (OPC) is an enzyme inhibitor that enhances the bioavailability of levodopa in the brain. Objectives This study evaluates the effect of Opicapone addition in PD‐LCIG patients, assessing its impact on motor fluctuations and dyskinesias. Secondly, the study analyses the impact of OPC on non‐motor symptoms, LCIG dosage, and peripheral neuropathy. Methods In this pilot study, 22 PD patients on LCIG were randomized to receive OPC or not, based on persistent or reemergent fluctuations. The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS‐UPDRS), Unified Dyskinesia Rating Scale (UDysRS), Montreal Cognitive Assessment (MoCA), electroneurography (ENG), LCIG doses, homocysteine, vitamin B12, and folic acid levels were measured at baseline (T0) and after 12 months (T1). Results Eleven patients added OPC (addOPC group), while 11 maintained standard treatment (nOPC group). At baseline, both groups had similar disease duration and severity. At T1, the addOPC group showed significant: (i) improvement in motor fluctuations evaluated by the MDS‐UPDRS part IV; (ii) reduction in dyskinesias (UDyRS); (iii) decrease in LCIG infusion rate; (iv) improvement in motor and non‐motor symptoms (MDS‐UPDRS parts I‐III); (v) increase in Vitamin B12. No significant differences were observed in the ENG data, and no serious adverse events occurred. Four addOPC patients (36%) discontinued OPC after 15 ± 2 months, mainly due to hallucinations. Conclusions OPC addition appeared well tolerated and beneficial in reducing motor fluctuations, dyskinesia, and LCIG dose. Randomized controlled trials are needed to confirm these findings.

Abstract licence: CC BY 4.0