Safety of opicapone use in Parkinson’s disease: review of literature and real-world safety data

Abstract

Parkinson's disease (PD) presents a significant global health concern with increasing prevalence and burden. This review article examines the safety data of drug Opicapone from literature and real-world sources of safety data, highlighting the need for vigilance over anti-parkinsonian drugs. For literature review, the PubMed database was mined which concluded that Opicapone, a selective COMT inhibitor for PD, demonstrated ADR like dyskinesia, nausea, vomiting, headache, and constipation where on the other hand real-world evidence showed no safety alerts or recalls initiated by regulatory authorities for Opicapone, but known risks like dyskinesia and hallucination were identified. However, clinical trial statistics revealed hypertension as the most probable ADR, alongside constipation, dizziness, dyskinesia, headache, somnolence, and hyperhidrosis. Whereas, unlisted events, such as somnolence, hyperhidrosis, pulmonary embolism, and abdominal pain, were also observed. Most ADRs belonged to the nervous system disorders and gastrointestinal disorders class which can be attributed to the pharmacological effect of Opicapone. It was concluded from this review that there is need for continuous safety vigilance for Opicapone use as despite the presence of well-structured safety guidance, new risks can emerge.