Ongentys opicapone

Drug Class

Catechol-O-methyltransferase (COMT) inhibitor

Mechanism

Opicapone is a peripheral, selective, and reversible catechol-O-methyltransferase (COMT) inhibitor that decreases the degradation of levodopa, thereby increasing levodopa levels in the brain.

Approved Indication

Adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing 'off' episodes.

What This Means For Patients

Ongentys is a once-daily, selective COMT inhibitor approved as an add-on therapy for Parkinson's disease patients. By preventing the breakdown of levodopa outside the brain, it extends the effect of levodopa and helps manage 'off' episodes when movement becomes difficult. It is available under the special-import drug policy in the Hainan Boao Lecheng pilot zone.

Regulatory Approvals

• FDA — approved (2020) — label
• EMA — approved (2016) — source

Pivotal Clinical Evidence

• BIPARK-I — Ferreira et al., Lancet Neurol 2016 (NCT01564927) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212489s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/ongentys
• https://www.gcs-web.com/