Drug updated on 9/4/2024
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.
Latest News
Summary
- Ongentys (opicapone) is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease (PD) experiencing "off" episodes.
- This summary is based on the review of seven systematic review(s)/meta-analysis(es). [1-7]
- Total ON-time and OFF-time: Opicapone 50 mg significantly increased total ON-time (MD 5.1, 95% CrI: 2.2-8.7) and reduced OFF-time by 49.91 minutes (95% CI: -71.39, -28.43) compared to placebo. Tolcapone also increased total ON-time with a mean difference of 3.2 hours (95% CI: 2.1-4.2).
- Levodopa Dose Reduction and UPDRS III Score: Opicapone facilitated more frequent levodopa dose reduction compared to placebo. Istradefylline improved UPDRS III scores (MD = -1.56; 95% CI [-2.71, -0.40]), whereas opicapone did not show significant improvement (MD = -0.63; 95% CI [-1.42, -0.15]).
- ON-time without Troublesome Dyskinesia: Opicapone increased ON-time without troublesome dyskinesia by 44.62 minutes (95% CI: 22.60-66.64).
- Treatment-Emergent Adverse Events (TEAEs): In short-term studies, opicapone 50 mg showed TEAEs such as dyskinesia (14.1%), elevated blood creatine phosphokinase (8.0%), and urinary tract infection (6.0%). In long-term studies, TEAEs included dyskinesia (16.1%), dry mouth (12.1%), decreased medication effect (12.1%), and Parkinson's disease exacerbation (7.8%).
- Serious Adverse Events (SAEs) and Treatment Discontinuation: Short-term studies reported SAEs at 4.8% and treatment discontinuation at 9.3%. In long-term studies, SAEs were 8.7% with treatment discontinuation at 8.4%.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Ongentys (opicapone) Prescribing Information. | 2020 | Neurocrine Biosciences, Inc., San Diego, CA |