FDA Approves Opicapone as Add-On Treatment for Patients with Parkinson Disease

Opicapone (Ongentys, Neurocrine Biosciences) has been approved by officials with the FDA as the first once-daily catechol-O-methyltransferase (COMT) inhibitor for patients with Parkinson disease, when combined with levodopa/carbidopa.

Individuals with the condition often struggle to control their motor fluctuations, affecting a wide range of functions, including speech, balance, and movement, which adversely impact many aspects of life, according to John L. Lehr, president and CEO of the Parkinson’s Foundation.

As Parkinson disease progresses, patients taking levodopa/carbidopa may begin experiencing “off” episodes between treatments, shown by an increase in the disease’s motor symptoms. “On” episodes, on the other hand, are the times when the motor symptoms are better controlled. According to a press release, the drug decreases “off” time and increases “on” time without the difficulties of dyskinesia.

Opicapone helps block the COMT enzyme that breaks down levodopa, thereby making more levodopa available to reach the brain and prolonging its clinical effects.

First-line treatments such as levodopa begin to lose effectiveness, and the beneficial effects of levodopa begin to wear off more quickly, as the disease progresses, causing more frequent and often debilitating motor fluctuations in patients, according to Robert A. Hauser, MD, director of the University of South Florida Parkinson’s Disease and Movement Disorders Center. In a statement, Hauser added that clinical studies have shown that adding once-daily opicapone to levodopa therapy significantly reduced ‘off’ time, leading to better and more consistent motor symptom control”

The FDA approval is based on data from 38 clinical studies, including 2 multinational phase 3 clinical studies, with over 1000 patients treated with opicapone. Findings from both multinational studies showed that the 50 mg dose of opicapone significantly reduced “off” time from baseline to week 14 or 15 compared to the placebo.

Opicapone capsules have been approved in 25 and 50 mg doses, and Neurocrine Biosciences expects to make them available to patients later in 2020, according to a statement.

REFERENCE

Neurocrine Biosciences Announces FDA Approval of Once-Daily ONGENTYS (opicapone) as an Add-On Treatment for Patients with Parkinson’s Disease Experiencing “Off” Episodes [news release]. Neurocrine Biosciences; April 27, 2020. https://neurocrine.gcs-web.com/news-releases/news-release-details/neurocrine-biosciences-announces-fda-approval-once-daily-0. Accessed April 27, 2020.