The US Food and Drug Administration (FDA) has approved once-daily oral opicapone (Ongentys, Neurocrine Biosciences, San Diego, CA) 25 mg and 50 mg capsules as an add-on treatment to levodopa/carbidopa in individuals with Parkinson disease (PD) experiencing off episodes. Opicapone also increases on time without troublesome dyskinesia, the time when the motor symptoms of individuals with PD are better controlled. The company plans to launch opicapone later this year.
"The FDA approval of Ongentys represents an important new treatment option for people with PD," said Robert A. Hauser, MD, professor of Neurology and director, University of South Florida PD and Movement Disorders Center." As PD 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."
In the BIPARK clinical studies (BIPARK-1 [NCT01568073] and BIPARK-2 [NCT01227655]), a 50 mg dose of opicapone significantly reduced off time from baseline to week 14 or 15 compared with placebo. On time without troublesome dyskinesia also increased from baseline to week 14 or 15 compared with placebo. Pooled safety data from the BIPARK-1 and BIPARK-2 studies showed the most common adverse reactions with opicapone, incidence at least 4% and greater than placebo, were dyskinesia, constipation, elevated blood creatine kinase, hypotension/syncope, and weight decrease.
"The FDA approval of Ongentys provides patients living with PD with an important new treatment option to help manage the disruptive and unpredictable motor fluctuations by decreasing off episodes and increasing on time without troublesome dyskinesia when taking levodopa/carbidopa," said Kevin C. Gorman, PhD, chief executive officer of Neurocrine Biosciences. "At Neurocrine Biosciences, our mission is to relieve patient suffering and we look forward to working with the PD community to make this new therapy available to patients later this year."
Opicapone is an oral, selective catechol-O-methyltransferase (COMT) inhibitor that helps block the COMT enzyme that breaks down levodopa. Opicapone protects levodopa by reducing its breakdown in the blood, making more levodopa available to reach the brain, prolonging its clinical effects, and helping individuals achieve motor symptom control.
Natalia P. Rocha, PharmD, MSc, PhD; Gabriela D. Colpo, PhD; Antonio L. Teixeira, MD, PhD, MSc; and Erin Furr Stimming, MD
Allie Massaro, MD
Brad Klein, MD, MBA, FAAN, FAHS, FAANEM, and Raissa Villanueva MD, MPH, FAAN