Objective: To assess safety and efficacy of Opicapone in patients treated with Levodopa and Safinamide presenting early morning “off” states and akinesia.

Background: Safinamide is a recently introduced Monoamine Oxidase B (MAO-B) inhibitor, used in Parkinson’s disease (PD) patients, especially with prominent motor fluctuations or painful dystonia. Opicapone, a novel Catechol-O-Methyltransferase (COMT) inhibitor, has been approved in Italy since autumn 2018 as add-on therapy to extend Levodopa effect duration. There is no clinical experience of add-on therapy with both drugs in PD patients.

Method: 56 patients with diagnosis of idiopathic PD, according to MDS criteria, were enrolled (29 males, 51.79%). Mean age was 71±3 years. Mean Levodopa Equivalent Dose (LED) was 412±28 mg daily. Mean Safinamide Equivalent Dose (SED) was 100±42 mg daily, typically administered in the early morning to improve daily motor fluctuations. Opicapone therapy was added after 96±12 days of stable Levodopa and Safinamide treatment. Opicapone Equivalent Dose (OED) was 50 mg daily, administered in the evening to prevent early morning akinesia and “off” states. Motor performance, dyskinesias and dystonias were evaluated with Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS). EQ-5D 3 level version (EQ-5D-3L) and Clinical Global Impression (CGI)-Improvement scale were also administered. Morning akinesia presence and duration was also investigated.

Results: A 42±12 minutes mean decrease of “Off” states duration was observed in this cohort. A MDS-UPDRS dyskinesia score (4.1 and 4.2 items) increase of 1.3±0.5 points was also reported, but LED adjustment with 10.5% reduction lead to improvement of the symptom. Morning akinesia resolution has been observed in 10 patients. Furthermore, 18 patients (32.14%) showed no clinical variations after Opicapone addition to Safinamide and Levodopa therapy, whereas 38 patients (67.86%) had clinical improvement at CGI-I. Only mild side effects were reported: insomnia in 2 patients, requiring Opicapone treatment withdrawal; daily sleepiness in 1 patient, xerostomia in 1 patient. No severe side effects, nor relevant gastrointestinal and hepatic adverse reactions were present.

Conclusion: Opicapone can be safely added in patients treated with Safinamide. The improvement was cross-related with daily LED, thus suggesting that the improvement was mostly related to Levodopa availability.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/addition-of-opicapone-to-safinamide-in-parkinsons-disease-patients/