Opicapone is a 'third-generation' COMT inhibitor that is taken once daily.
According to researchers, opicapone "could enable a simplified drug regimen that allows physicians to individually tailor the existing levodopa daily regimen, by potentially reducing the total daily levodopa dose, increasing the dose interval, and ultimately reducing the number of intakes".
Two randomised, double-blind, phase III studies evaluated the safety and efficacy of opicapone in 1027 patients with Parkinson's disease and end-of-dose motor fluctuations being treated with levodopa and a dopa decarboxylase inhibitor, either alone or in combination with other antiparkinsonian drugs.
Non-inferior to entacapone
In the placebo- and active-controlled Bi-Park 1 study, investigators randomised 600 patients to receive opicapone 5mg, 25mg or 50mg once daily, placebo or entacapone 200mg (with every levodopa intake) for 14–15 weeks.
The primary endpoint was the change from baseline to end of study
treatment in absolute time in the off state, as assessed by daily patient diaries.
The mean change in time in the off state was –116.8 min (95% CI –144.2 to –89.4) in patients treated with opicapone 50mg, compared with –56.0 min (95% CI –82.3 to –29.7) in those given placebo and –96.3 min (95% CI –122.6 to –70.0) in those who received entacapone.
Treatment with opicapone 50mg was superior to placebo (mean difference in change from baseline –60.8 min, 95% CI –97.2 to –24.4; p=0.0015) and non-inferior to entacapone (mean treatment difference –26.2 min, 95% CI –63.8 to 11.4; p=0.0051).
The most common adverse effects of opicapone were nervous system disorders. Dyskinesia was the most frequently reported treatment-emergent adverse event, occurring in 16% of the opicapone 50mg group, 8% of the entacapone group and 4% of the placebo group.
Potential treatment of choice
"[Opicapone] may become the treatment of choice when levodopa-treated patients need additional help to improve motor symptoms such as wearing-off in Parkinson's disease," said Professor Heinz Reichmann, Professor and Chair of the Department of Neurology and Dean of the Medical Faculty at the University of Dresden.
Opicapone is the second new Parkinson's disease treatment to become available in 2016, following the launch of safinamide (Xadago).