Opicapone: A Review in Parkinson’s Disease

@article{Scott2016OpicaponeAR,
  title={Opicapone: A Review in Parkinson’s Disease},
  author={Lesley J. Scott},
  journal={Drugs},
  year={2016},
  volume={76},
  pages={1293-1300}
}
  • L. Scott
  • Published 6 August 2016
  • Medicine, Psychology
  • Drugs
Oral opicapone (Ongentys®), a potent, third-generation, long-acting, peripheral catechol-O-methyltransferase (COMT) inhibitor, is approved as adjunctive treatment to levodopa (L-Dopa)/dopa-decarboxylase inhibitor (DDCI) therapy in adults with Parkinson’s disease (PD) and end-of-dose motor fluctuations who cannot be stabilized on those combinations. In 14- to 15-week, double-blind, multinational trials and in 1-year, open-label extension studies in this patient population, opicapone was an… 

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Opicapone is a novel COMT inhibitor that has been recently approved by the European Medicines Agency as an adjunctive therapy to combinations of LD and aromatic amino acid decarboxylase inhibitor in adult PD patients with end-of-dose motor fluctuations.

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Opicapone’s lifecycle, its clinical pharmacological data, safety, tolerability and pharmacovigilance evidence, and its role in the management of motor fluctuations in PD are discussed, as well as its emerging place in international recommendations.

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This article summarizes knowledge about a new third-generation COMT inhibitor, namely opicapone (OPC) (Search period: 2016–2019), and details the pharmacological profile of OPC and the results of completed clinical trials.

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Opicapone is a safe and efficacious option to combat motor fluctuations for PD patients taking levodopa and should be considered in combination with other augmenting medications with different mechanisms of action, to help treat motor and non-motor fluctuations in PD.

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Opicapone, a recently introduced catechol-o-methyl transferase (COMT) inhibitor has the advantage of being administered once daily, and has pharmacokinetic data to indicate it offers a greater degree of COMT inhibition than entacapone.

References

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Evaluation of opicapone on cardiac repolarization in a thorough QT/QTc study

TLDR
Opicapone, a novel third‐generation catechol‐O‐methyltransferase inhibitor for use as adjunctive therapy in levodopa‐treated Parkinson's disease patients, was investigated on cardiac repolarization in healthy adult volunteers, confirming that opicapone has no QT‐prolonging effect.

Pharmacokinetics, Pharmacodynamics and Tolerability of Opicapone, a Novel Catechol-O-Methyltransferase Inhibitor, in Healthy Subjects

TLDR
Opicapone was well-tolerated and presented dose-proportional kinetics, and sustained inhibition of erythrocyte soluble COMT activity was demonstrated, providing a basis for further clinical development of opicapone.

Opicapone: a short lived and very long acting novel catechol-O-methyltransferase inhibitor following multiple dose administration in healthy subjects.

TLDR
Despite its short elimination half-life, opicapone markedly and sustainably inhibited erythrocyte S-COMT activity making it suitable for a once daily regimen.

Effect of 3 Single‐Dose Regimens of Opicapone on Levodopa Pharmacokinetics, Catechol‐O‐Methyltransferase Activity and Motor Response in Patients With Parkinson Disease

TLDR
It was concluded that OPC is a new COMT inhibitor that significantly decreased COMT activity and increased systemic exposure to levodopa in PD patients with motor fluctuations.

Effect of moderate liver impairment on the pharmacokinetics of opicapone

TLDR
The bioavailability of an orally administered single dose of 50 mg OPC was significantly higher in patients with moderate chronic hepatic impairment, perhaps by a reduced first-pass effect.

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TLDR
It is anticipated that opicapone adjunct therapy at the dosages of 25 and 50 mg will provide an enhancement in levodopa availability that will translate into clinical benefit for Parkinson’s disease patients.

Efficacy and safety of opicapone, a new COMT-inhibitor, for the treatment of motor fluctuations in Parkinson's Disease patients: BIPARK-II study

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TLDR
The PK and PD profiles of OPC were similar in the Japanese and white populations, thus, ethnicity and COMT polymorphisms had no significant impact on the OPC PK andPD in the conditions of the study.