Opicapone: follow-up on the BIPARK I and II trials

The peripheral catechol-O-methyltransferase (COMT) inhibitor opicapone proved effective in the treatment of motor fluctuations in PD patients in BIPARK-I and II [1,2].

In a post-hoc analysis of these two large, pivotal, multinational trials, opicapone was effective regardless of baseline presence of dyskinesia and of concurrent rasagiline use [3,4]. In another post-hoc analysis, opicapone was effective in reducing motor fluctuations in ‘early fluctuators’, resulting in a significant proportion of responders (achieving at least 1 hour of OFF-time reduction or 1 hour of ON-time increase), similar to the total study population [5].

In the 1-year extension of the BIPARK-I study, the placebo and entacapone groups switched to open-label opicapone. During this period there was no worsening of non-motor symptoms for subjects in these groups [6]. Patients who had switched from placebo presented significantly less disability. At the end of the double-blind period, total scores on the Non-Motor Symptoms Scale (NMSS) in the 199 ‘switchers’ had decreased in all treatment groups. Mean changes from baseline were -5.7, -4.7, and -2.0 for placebo, entacapone, and opicapone 50 mg, respectively. During the 1-year extension the scores further decreased: -3.8 (P=0.041), -0.2 (P=0.899), and -0.4 (P=0.849), respectively.

1. 
   
   1. Ferreira J, et al. Lancet Neurology 2016;15(2):154-65.
   2. Lees A, et al. JAMA Neurol. 2017;74(2):197-206.
   3. Fabregues O, et al. EAN 2019, EPO1198.
   4. Lees A, et al. EAN 2019, EPO2174.
   5. Ferreira J, et al. EAN 2019, EPR1075.
   6. Lees A, et al. EAN 2019, EPO2176.

Posted on 27 August, 201918 March, 2021