Key points

Key points

The content of this evidence summary was up-to-date in March 2017. See summaries of product characteristics (SPCs), British national formulary (BNF), or the MHRA or NICE websites for up-to-date information.

Regulatory status: New medicine. Opicapone is a catechol-O-methyl transferase (COMT) inhibitor. It received a European marketing authorisation in June 2016 and was launched in the UK in October 2016. It is licensed for adjuvant therapy to preparations of levodopa/DOPA decarboxylase inhibitor (DDCI) in adults with Parkinson's disease who are experiencing end-of-dose motor fluctuations and cannot be stabilised on those combinations.


This evidence summary reviewed 1 randomised placebo- and active-controlled trial in people with Parkinson's disease of at least 3‑year duration, who were taking a stable dose of levodopa and experiencing end-of-dose motor fluctuations. Most participants were also taking other Parkinson's disease medicines, most commonly a dopamine agonist. There are limited data on the use of opicapone as a first choice adjunct therapy to levodopa.

The main clinical benefits of opicapone 50 mg up to 15 weeks were reduced off time of 60.8 minutes and an increase in on time without troublesome dyskinesia of 62.6 minutes, compared with placebo. The effect was maintained at 1 year in an open-label extension study. Opicapone 50 mg was shown to be non-inferior to entacapone 200 mg for reducing off time.

Overall, opicapone was well tolerated with a relatively low incidence of adverse events compared with placebo and entacapone. Dyskinesia was the most commonly reported adverse event. Dose adjustment of levodopa therapy within the first days to first weeks after initiating treatment with opicapone will often be necessary. Specialists who commented on this evidence summary suggested that opicapone may be an option to consider when entacapone is not tolerated or is inadequate at controlling symptoms.

The NICE guideline on Parkinson's disease makes recommendations on the place in therapy of adjuvant treatments. The choice of treatment will depend on the person's clinical and lifestyle characteristics, and their preferences, after an informed discussion about the benefits and risks of treatment.

A summary to inform local decision-making is shown in table 1.

Table 1 Summary of the evidence on effectiveness, safety, patient factors and resource implications


  • Ferreira et al. 2016 (n=600) found that opicapone, as an adjunct to levodopa, was more effective than placebo at reducing off time in people with Parkinson's disease (mean difference of 60.8 minutes). Improvements in on time without troublesome dyskinesia were also seen in people treated with opicapone (mean difference of 62.6 minutes compared with placebo).

  • Opicapone was shown to be non-inferior to entacapone for reducing off time.

  • There was a statistically significant improvement in clinician global impression of change (measured by CGI-C and PGI-C) with opicapone 50 mg compared with placebo.


  • The SPC states that the most common adverse reactions reported were central nervous system disorders with dyskinesia being reported as very common (10 in 100 people or more).

  • Common (1 in 100 or more) adverse reactions included dizziness, headache and somnolence.

Patient factors

  • Opicapone enhances the effects of levodopa. The SPC states it is often necessary to adjust the daily dose of levodopa within the first days to first weeks after starting treatment with opicapone, to reduce levodopa-related dopaminergic adverse reactions such as dyskinesia.

  • Opicapone is taken once a day, which may enable a simplified regimen when taken with levodopa compared to other COMT inhibitors.

  • Impulse control disorders may occur with dopaminergic medicines and patients and carers should be made aware of the behavioural symptoms of these.

  • People taking opicapone should be advised that opicapone in association with levodopa may have major influence on the ability to drive and use machines, due to dizziness, symptomatic orthostatism or somnolence.

Resource implications

  • Opicapone 50 mg tablets cost £93.90 for 30 tablets (MIMS, February 2017, excluding VAT).

  • 30‑day treatment costs (excluding VAT) for: opicapone 50 mg is £93.90 (MIMS, February 2017); entacapone based on maximum dose is £50.30 (Drug Tariff, February 2017); and tolcapone based on 100 mg dose is £85.68 (MIMS, February 2017).