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# Neurocrine Biosciences’ Opicapone NDA Accepted
- URL: https://www.fdaweb.com/neurocrine-biosciences-opicapone-nda-accepted/
- Published: 2019-07-11T12:00:00.000Z
- Updated: 2026-09-15T01:37:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144512

FDA has accepted for review a Neurocrine Biosciences NDA for opicapone, a once-daily, oral, selective catechol-O-methyltransferase inhibitor as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing off episodes. The agency has set a standard 12-month review with a user fee target action date of 4/26/2020.

Neurocrine says the submission is based on data from 38 clinical studies, including two Phase 3 studies (BIPARK-1 and BIPARK-2), with more than 1,000 Parkinson’s disease patients treated with opicapone. The primary endpoint in both studies was the change from baseline in absolute time in the off state, as assessed by patient diaries.

The company says opicapone works by prolonging the clinical effect of levodopa through decreasing its conversion rate into 3-O-methyldopa to allow for greater availability in the brain.