Drug updated on 10/28/2024
Dosage Form | Capsule (oral; 25 mg, 50 mg) |
Drug Class | Catechol-O-methyltransferase (COMT) inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinsons disease (PD) experiencing off episodes.
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Summary
- This summary is based on the review of seven systematic review(s)/meta-analysis(es). [1-7]
- Opicapone significantly increased total ON-time in Parkinson’s disease (PD) patients, with 50 mg showing a mean difference of 5.1 hours (95% CrI: 2.2–8.7) compared to placebo, and it was effective in reducing OFF-time by 49.91 minutes (95% CI: -71.39, -28.43).
- Opicapone facilitated levodopa dose reduction more frequently than placebo, and it was ranked as the best Catechol-O-Methyltransferase (COMT) inhibitor for increasing total ON-time (Surface Under the Cumulative Ranking Curve (SURCA), 0.796).
- Opicapone increased the rate of achieving ON-time >1 hour, with the exception of the 5 mg dose, which did not show statistical significance (Odds Ratio (OR) 1.4, 95% CrI: 0.74–2.4).
- Opicapone was associated with increased adverse events compared to placebo, particularly dyskinesia, which occurred in 14.1% of patients in short-term studies and 16.1% in long-term studies. Other common adverse events included elevated blood creatine phosphokinase levels (8.0% short-term; 7.4% long-term) and dry mouth (12.1% long-term).
- Serious treatment-emergent adverse events (SAEs) occurred in 4.8% of patients in short-term studies and 8.7% in long-term studies, with treatment discontinuation rates of 9.3% and 8.4% respectively. Opicapone showed a higher incidence of dyskinesia (Relative Risk (RR) = 3.47) compared to istradefylline (RR = 1.77).
- The studies focused on levodopa-treated adults with Parkinson's disease experiencing motor fluctuations, particularly advanced PD (Parkinson's disease) patients. Opicapone was effective in increasing ON-time and reducing OFF-time in these populations, but dyskinesia was a common adverse event, requiring close monitoring in patients who are susceptible to or already experiencing dyskinesia.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Ongentys (opicapone) Prescribing Information. | 2023 | Amneal Pharmaceuticals LLC., Bridgewater, NJ |