Drug updated on 4/29/2024
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 |