Opicapone for the treatment of Parkinson’s disease: an update

ABSTRACT

Introduction: Parkinson’s disease is a neurodegenerative disorder which is characterized by the combination of motor and non-motor symptoms. As yet, there is no curative treatment. The gold standard for symptom control is levodopa. Two years after the start of substitution therapy, around 50% of patients experience some degree of fluctuation in motor performance. Catechol-O-methyltransferase (COMT) inhibitors are important agents in treating these fluctuations.

Areas covered: This article summarizes our knowledge about a new third-generation COMT inhibitor, namely opicapone (OPC) (Search period: 2016–2019). The authors detail the pharmacological profile of OPC and summarize the results of completed clinical trials. In addition, they briefly summarize the achievements of the past few years.

Expert opinion: Based on clinical trials conducted so far, OPC is an effective and safe new drug. In comparison to entacapone and tolcapone, it does not require close laboratory monitoring or multiple oral administrations, which may result in better adherence. No serious adverse event was reported during the drug development phases. Dyskinesia was the most common complaint. Further comparative studies and broader trial inclusion criteria are needed to help the decision between COMT inhibitors and to expand the patient spectrum where this drug can be applied.

KEYWORDS:

• COMT inhibitor
• opicapone
• Parkinson’s disease

Article highlights

• Since 24 June 2016 a third COMT inhibitor, namely opicapone (OPC) is also available, which was approved by the European Medicine Agency for the treatment of end-of-dose motor fluctuations in adult patients whose symptoms are not controllable by LD/DOPA decarboxylase inhibitor combination.

• OPC is a peripherally acting, reversible COMT inhibitor, requiring only once daily administration compared to ENT, and has no documented hepatotoxic effect as compared to TLC, thus no close laboratory monitoring is required.

• The performed clinical trials did not register fatal outcome after OPC treatment. The most common adverse event was dyskinesia.

• Further comparative studies and broader trial inclusion criteria are needed to help the decision between COMT inhibitors and to expand the patient spectrum where this drug can be applied.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

One referee was an investigator for one of the two phase III trials with opicapone and served as a consultant for Bial in opicapone’s development program. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Additional information

Funding

This work is funded by the project GINOP 2.3.2-15-2016-00034 and by the Ministry of Human Capacities, Hungary grant 20391-3/2018/FEKUSTRAT. Dénes Zádori is supported by the János Bolyai Research Scholarship from the Hungarian Academy of Sciences.