Review the safety data of opicapone (OPC) after five years of marketing experience worldwide.

Patient exposure to marketed OPC was estimated based on worldwide ex-factory sales cumulatively until 30 September 2021 (assuming the ex-factory amounts delivered were entirely dispensed and administered, and were used at the dosage of 1 hard capsule/day).

From the first marketing authorisation until 30 September 2021, safety data was pooled and analysed from global post-marketing sources, including spontaneous, health authorities, literature reports, and non-interventional studies. Cumulative summary tabulations of adverse events arranged by primary System Organ Class (SOC) and preferred terms within each SOC were retrieved and sorted. 

The estimated patient exposure was 1 413 624 patient-months during the period, corresponding to 117 802 patient-years.

In the 5-year period, 4035 events were reported, 545 (13.5%) serious and 3490 (86.5%) non-serious. This corresponds to an incidence of 34.3 reports per 1000 patient-years.

The 5 SOCs with the highest number of events were “Nervous system disorders”, “General disorders and administration site conditions”, “Psychiatric disorders”, “Gastrointestinal disorders” and “Surgical and medical procedures”.

The 10 most frequently reported adverse events were “Dyskinesia”, “Muscle rigidity”, “Hallucination”, “Bradykinesia”, “Constipation”, “Tremor”, “Gait disturbance”, “Freezing phenomenon”, “Sleep disorder” and “Reduced facial expression”.

Safety reports during 5 years of post-marketing experience with OPC were uncommon, and mostly refer to non-serious adverse events. Motor-symptoms of PD were among the most frequently reported adverse events. No new relevant safety concern was identified. OPC continues to have an adequate safety and tolerability profile with a favourable benefit-risk ratio.