Opicapone

Catechol-O-methyltransferase (COMT) inhibitor: An Investigational Treatment for Parkinson’s Disease

COMT inhibitors are utilized to prolong the duration of effect of levodopa which is the primary treatment option for Parkinson’s disease patients. Administration of levodopa often results in adequate control of Parkinson’s symptoms, also referred to as “ON time”; however, there are periods of the day where the effects of levodopa wear off and motor symptoms worsen, referred to as “OFF time.”

Opicapone is a novel, once-daily, peripherally-acting, selective COMT inhibitor being developed as adjunct therapy to levodopa/DOPA decarboxylase inhibitors in Parkinson’s patients. Opicapone works through decreasing the conversion rate of levodopa into 3-O-methyldopa, thereby reducing the OFF time and extending the ON time period associated with Parkinson’s treatment.

Opicapone Development: BIAL Collaboration

On February 9, 2017, Neurocrine Biosciences entered into an exclusive licensing agreement with BIAL – Portela & CA, S.A. (BIAL) for the development and commercialization of opicapone in the United States and Canada. Neurocrine Biosciences is responsible for the management and cost of all opicapone development and commercialization activities in the United States and Canada. In July 2019, Neurocrine Biosciences announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for opicapone as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing OFF episodes. The FDA has set a standard 12-month review process with a Prescription Drug User Fee Act (PDUFA) target action date of April 26, 2020.

In June 2016, the European Commission authorized ONGENTYS® (opicapone) as an adjunct therapy to preparations of levodopa/DOPA decarboxylase inhibitors (DDCIs) in adult patients with Parkinson’s disease. This approval was based on data from a clinical development program that included 28 clinical studies of more than 900 patients treated with opicapone in 30 countries worldwide. Opicapone has not been approved by the United States Food and Drug Administration.