OBJECTIVES: Opicapone is an oral, once-daily, selective catechol-O-methyltransferase (COMT) inhibitor, approved as an adjunctive treatment to levodopa/carbidopa (LD/CD) in patients with Parkinson’s disease (PD) experiencing “OFF” episodes. OPTI-ON (OPicapone Treatment Initiation OpeN-Label Study) was a “real-world” study of opicapone use in the US that evaluated the characteristics, treatment patterns, and safety/tolerability of patients initiating opicapone treatment.

METHODS: OPTI-ON was a 6-month, prospective, single-arm, multicenter, observational, longitudinal study that included patients with PD experiencing “OFF” episodes who were newly prescribed opicapone adjunctive to LD/CD. Patient-reported outcomes including the Patient Global Impression of Severity in the “OFF” state (PGI-S OFF), Patient Global Impression of Change (PGI-C), Non-Motor Fluctuations PGI-S (NMFs PGI-S), and Medication Satisfaction Questionnaire (MSQ) were obtained at baseline and throughout follow-up.

RESULTS: Overall, 164 participants completed the study. On the PGI-S OFF, more participants rated their “OFF”-time symptom severity as “none” or “very mild” at 6 months versus baseline (20.4% vs. 10.3%). Fewer rated their “OFF”-time as “moderately severe” to “extremely severe” at 6 months versus baseline (17.3% vs. 26.5%). For the PGI-C, 23.5% of patients were “much improved” or “very much improved” at 6 months. On the NMFs PGI-S, fewer participants self-rated themselves as “markedly affected” to “most extremely affected” with non-motor fluctuations at 6 months versus baseline (3.2% vs. 11.9%). On the MSQ, 42.3% of participants were “very satisfied” or “extremely satisfied” with opicapone at 6 months; in contrast, only 14.1% were very or extremely satisfied with their LD/CD-only regimen at baseline.

CONCLUSIONS: Results from the OPTI-ON study, along with the efficacy demonstrated in Phase 3 studies, demonstrated that once-daily opicapone may improve the quality of “OFF”-time, more effectively manage motor and non-motor fluctuations, and increase patients’ satisfaction with their PD treatment regimen.