Opicapone

(Ongentys®)

Opicapone

Latest News

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Drug updated on 5/17/2024

Dosage FormCapsule (oral; 25 mg, 50 mg)
Drug ClassCatechol-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
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  • Opicapone (Ongentys) is indicated as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes. It shows a significant increase in total ON-time compared to placebo and other catechol-O-methyltransferase inhibitors such as entacapone and tolcapone, suggesting it may offer a more potent option for prolonging the therapeutic effects of levodopa.
  • Seven studies focused on comparing the efficacy and safety of opicapone with other drugs used for treating Parkinson’s disease.
  • When assessed against newer treatments like istradefylline, both medications demonstrated a significant reduction in "off" time, but istradefylline showed slight superiority in improving UPDRS III scores, indicating marginally better management of motor symptoms.
  • In terms of safety comparison, opicapone manifests an increased risk of dyskinesia which is comparably higher than seen with entacapone but similar or slightly less concerning when contrasted with tolcapone, depending upon the dose. However, compared to istradefylline, opicapone has a higher incidence rate for dyskinesia.
  • Despite adverse effects including dyskinesia, urinary tract infections, dry mouth, nausea, and insomnia, particularly at the dosage level of 50 mg; overall discontinuation rates due to these events were relatively low, suggesting that the benefits outweigh the risks associated with therapy.
  • The reviewed studies predominantly included adult patients already undergoing levodopa treatment who experienced “off” episodes during their course of dealing with Parkinson’s Disease. While direct subgroup analyses were not extensively detailed, effectiveness and safety profiles suggest it could be beneficial, especially for those experiencing fluctuations in response to Levodopa.