Opicapone

(Ongentys®)

Ongentys®

Drug updated on 12/11/2024

Dosage FormCapsule (oral; 25 mg, 50 mg)
Drug ClassCatechol-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
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  • 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% credible interval (CrI): 2.2–8.7) compared to placebo, and it was effective in reducing OFF-time by 49.91 minutes (95% confidence interval (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 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.