Objective: Investigate the likelihood of association of Opicapone (OPC) with psychotic symptoms (other than hallucinations).
Background: Neuropsychiatric symptoms frequently occur in Parkinson’s Disease (PD) patients, including psychotic symptoms in at least 20% of medication-treated patients [1,2]. Risk factors for PD psychosis include exposure to PD medications, among other factors [1]. OPC is a once-daily catechol-O-methyltransferase (COMT) inhibitor proven to be effective in PD patients with motor fluctuations and is approved in 43 countries, with an estimated patient exposure of over 2 million patient-months by June 2022.
Method: The master safety database for OPC was searched using the Standardised MedDRA Query ‘Psychosis and psychotic disorders’ narrow, which includes (but is not limited to) the Preferred Terms ‘delusion’ and ‘psychotic disorder’ (hallucinations were excluded as they are known potential adverse drug reactions with OPC). Cases were retrieved from the database cumulatively since OPC first marketing authorization (2016) until 24-Jun-2022.
As psychiatric symptoms/comorbidities are common in PD patients, a close temporal relationship (time to onset ≤ 14 days) and/or positive re-/dechallenge were considered appropriate criteria for a suspected relationship to OPC. The cases fulfilling these criteria were further evaluated by an independent psychiatric expert.
Results: A total of 288 valid cases were retrieved, 282 from post-marketing sources and 6 from clinical trials. After exclusion of cases with hallucinations only, 69 cases related to the topic of interest were identified (59 with sufficient information for assessment and 10 with insufficient information). Fifteen cases with psychotic symptoms other than hallucinations either had time to onset of ≤ 14 days or a positive dechallenge and were evaluated by the psychiatric expert.
Only three cases were considered probably related to OPC by the expert. The remaining cases were considered possibly or unlikely related to OPC, or an alternative diagnosis was proposed. Four cases were considered as hallucination events by the expert. No case with a positive rechallenge was identified.
Conclusion: It is concluded that, at this stage, the review of the limited number of cases from the past 6 years of OPC safety data that reported psychotic symptoms other than hallucinations did not provide sufficient evidence of a causal relationship to OPC.
References: [1] Fredericks D, Norton JC, Atchison C, Schoenhaus R, Pill MW. Parkinson’s disease and Parkinson’s disease psychosis: a perspective on the challenges, treatments, and economic burden. Am J Manag Care. 2017 Apr;23(5 Suppl):S83-S92. PMID:28715903
[2] Papapetropoulos S, Mash DC. Psychotic symptoms in Parkinson’s disease. From description to etiology. J Neurol. 2005 Jul;252(7):753-64. doi: 10.1007/s00415-005-0918-5. PMID: 15999234.
To cite this abstract in AMA style:
L. Guedes, I. Peixoto, K. Erb-Zohar, C. Novais, M. Sampaio, C. Santos, J. Graça, V. Vuca, P. Calero, H. Gama. Evaluation of cases of psychosis from opicapone safety data [abstract]. Mov Disord. 2023; 38 (suppl 1). https://www.mdsabstracts.org/abstract/evaluation-of-cases-of-psychosis-from-opicapone-safety-data/. Accessed November 23, 2024.« Back to 2023 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/evaluation-of-cases-of-psychosis-from-opicapone-safety-data/