Drug updated on 3/28/2024
| Dosage Form | Capsule (oral; 25 mg, 50 mg) |
| Drug Class | Catechol-O-methyltransferase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes.
Summary
- Opicapone (Ongentys) is indicated as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes.
- A total of 5 systematic reviews/meta-analyses were reviewed, providing pooled scientific evidence on the efficacy and safety of opicapone as an adjuvant to levodopa.
- The meta-analysis showed that compared with placebo, opicapone reduced off-time by approximately 50 minutes during the double-blind period and increased on-time without troublesome dyskinesia by about 45 minutes.
- However, it was found that the risk ratio for occurrence of dyskinesia was around three times greater in patients receiving opicapone than those given a placebo.
- In terms of tolerability over short-term (<6 months) and long-term (≥6 months), studies demonstrated that opicapone had generally low risks for adverse events such as elevated blood creatine phosphokinase levels or urinary tract infection; however, incidences of dyskinesia were reported more frequently among users.
- When compared against other catechol-O-methyl transferase inhibitors like entacapone and tolcapone used in treating Parkinson's disease, one study concluded that while all three drugs increased patient's total ON-time relative to placebo use, only opicapone presented fewer safety problems across selected indicators including incidence rates for adverse events like dyskinesia or nausea among others.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Ongentys (opicapone) Prescribing Information. | 2020 | Neurocrine Biosciences, Inc. San Diego, CA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Efficacy and safety of opicapone for motor fluctuations as an adjuvant to levodopa therapy in patients with Parkinson’s disease: a systematic review and meta-analysis. | 2022 | Journal of Parkinson’s Disease |
| Adverse event profiles of adjuvant treatment with opicapone in Parkinson’s disease: A systematic review and meta-analysis. | 2022 | Frontiers in Pharmacology |
| Opicapone as an add-on to levodopa for reducing end-of-dose motor fluctuations in Parkinson’s disease: a systematic review and meta-analysis. | 2022 | Journal of Comparative Effectiveness Research |
| Different catechol-o-methyl transferase inhibitors in Parkinson's disease: a Bayesian network meta-analysis. | 2021 | Frontiers in Neurology |
| Istradefylline versus opicapone for “off” episodes in parkinson’s disease: a systematic review and meta-analysis. | 2021 | Annals of Neurosciences |