Safety of opicapone in the elderly and very elderly population: an analysis of reported events in a global safety database.

INTRODUCTION

Older people with Parkinson's disease (PD) are under-represented in clinical trials despite increasing disease burden and complexity. Although opicapone is approved as an adjunct to levodopa, data in elderly populations are limited. This study assessed its real-world safety in the elderly using post-marketing pharmacovigilance data.

METHODS

This retrospective analysis used the global opicapone safety database (data-lock: 31 Jan 2026). Valid case safety reports with opicapone as the suspected product were included and classified as elderly (≥65-84 years) or very elderly (≥85 years). Adverse events were analyzed descriptively by system organ class, preferred term, and seriousness. Non-standard use and treatment actions were also assessed.

RESULTS

Among 2914 analyzed cases (2558 elderly; 356 very elderly), 7195 adverse events were reported. Most reported events were non-serious (81.4% of events in elderly cases; 73.5% in very elderly cases). Dyskinesia was the most frequently reported event in both groups (7.1%-7.7% of events), followed by hallucination and visual hallucination (all <5% of events). Serious events accounted for a greater proportion of reported events in the very elderly versus elderly group (26.5% vs 18.6%), although no individual preferred term exceeded 5%. Non-standard use accounted for 6.0% and 3.5% of reported events in the very elderly and elderly groups, respectively, and included altered administration and off-label indications. Treatment was discontinued in approximately half of cases in both groups.

CONCLUSION

Reported adverse event patterns were generally consistent with the established safety profile of opicapone across both age groups. No unexpected reporting patterns were observed; however, findings should be interpreted within the limitations of spontaneous pharmacovigilance data.