Comparative Efficacy of Opicapone and Entacapone in the Management of Motor Fluctuations in Parkinson’s Disease
Stuart Isaacson1, Fahd Amjad2, Sandeep Thakkar3, Bruno Dias4, Helena Brigas4, Bita Naderi5, Ghazal Banisadr5, Stanley Fisher5
1Parkinson's Dis & Mov Dis Ctr of Boca Raton, 2Georgetown University Hospital, 3Hoag Hospital, 4BIAL – Portela & Ca S.A., 5Amneal Pharmaceuticals
Objective:
To compare the clinical efficacy of two catechol-O-methyltransferase (COMT) inhibitors, opicapone (OPC) and entacapone (ENT).
Background:
OPC and ENT are used as adjunctive therapy to levodopa (LD) to improve the bioavailability of LD and reduce peak-trough fluctuations.
Design/Methods:
BIPARK I was a multicenter, double-blind (DB), 14- to 15-week, placebo- and active-controlled (ENT) phase 3 study, followed by a 1-year open-label extension (OLE) to evaluate the treatment effect of OPC in patients with Parkinson’s disease (PD) and motor fluctuations. A review of BIPARK I efficacy data and a sub-analysis of the OLE were conducted.
Results:
BIPARK I established the noninferiority of OPC 50mg vs ENT 200mg. Moreover, it demonstrated OPC’s effectiveness in reducing “Off” time, with greater magnitude of reduction in time in “Off” state vs ENT (LS mean change of –116.8min vs –96.3min, respectively). A higher proportion of patients on OPC vs ENT showed minimally, much or very much improved Clinician (73% vs 50.9% respectively, p=0.0070) and Patient (72.1% vs 52.5% respectively, p=0.0091) Global Impression of Change scores.
At the end of the DB study, the proportion of OPC-treated patients who woke up in “On” status increased by 12.2% from baseline vs. 7.5% for ENT. For OPC -treated patients, time-to-“On” decreased by 17.7% vs 1.9% for ENT. The reduction of morning OFF-time (%/h) was two-fold greater for OPC 50mg vs ENT (20% vs 10%).
In the OLE sub-analysis, patients who switched from ENT to OPC and ended the OLE study on OPC 50mg, had significant reductions in "Off" time (LS mean change: -68.2min; p=0.0025) and significant improvements in "On" time (LS mean change: +53.3min; p=0.0195).
Conclusions:
Compared to ENT, OPC provides numerically higher reduction of “Off” time, increased “On” time, and a higher proportion of patients reporting meaningful clinical improvement. The benefit was maintained in the OLE study, further supporting its long-term efficacy.
Disclaimer: Abstracts were not reviewed by Neurology® and do not reflect the views of Neurology® editors or staff.