FDA Clears Opicapone (Ongentys) as Add-On Therapy in PD

Megan Brooks

April 28, 2020

The US Food and Drug Administration (FDA) has approved opicapone (Ongentys, Neurocrine Biosciences) as add-on therapy for patients with Parkinson disease who experience "off" periods while receiving a stable levodopa/carbidopa regimen.

Opicapone is a once-daily, oral, peripheral, selective and reversible catechol-O-methyltransferase (COMT) inhibitor. It is available in 25-mg and 50-mg capsules. By blocking the COMT enzyme, opicapone helps increase and extend levodopa's dopaminergic effects.

"The FDA approval of Ongentys represents an important new treatment option for people with Parkinson's disease," Robert A. Hauser, MD, director, University of South Florida Parkinson's Disease and Movement Disorders Center, Tampa, said in a company news release.

"As Parkinson's disease progresses, first-line treatments such as levodopa begin to lose effectiveness and the beneficial effects of levodopa begin to wear off more quickly, causing more frequent and often debilitating motor fluctuations in patients. Clinical studies have shown that adding once-daily Ongentys to levodopa therapy significantly reduced 'off' time,' leading to better and more consistent motor symptom control," Hauser noted.

The approval of opicapone was supported by 38 clinical trials, including two multinational phase 3 studies (BIPARK-1 and BIPARK-2), involving more than 1000 patients with Parkinson disease who underwent treatment with the drug.

BIPARK-1 and BIPARK-2 enrolled patients who were experiencing at least 1.5 hours of "off" time daily while awake despite receiving stable levodopa/carbidopa doses.

Data from both studies showed that opicapone reduced "off" time and increased "on" time without troublesome dyskinesia from baseline to week 14 or 15 compared to placebo.

The most common side effects (incidence ≥4% vs placebo) were dyskinesia, constipation, an increase in blood creatine kinase levels, hypotension/syncope, and decreased weight. Full prescribing information is available online.

"The Parkinson's disease community is encouraged by the FDA approval of a new add-on treatment option to help patients further control symptoms, enabling them to better cope with this progressive disease," John L. Lehr, president and chief executive officer of the Parkinson's Foundation, said in the news release.

Neurocrine Biosciences plans to launch opicapone in the Unied States later this year. The drug was approved in Europe in 2016.

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