FDA approves Ongentys an add-on treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes.- Neurocrine Biosciences.

Neurocrine Biosciences, Inc. announced that the FDA has approved once-daily oral Ongentys (opicapone) 25 mg and 50 mg capsules as an add-on treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes.

As the disease progresses, patients taking levodopa/carbidopa may begin to experience “off” time between treatment doses, during which an increase in Parkinson’s disease motor symptoms such as tremor, slowed movement and difficulty walking occur. Ongentys also increases “on” time without troublesome dyskinesia, the time when the motor symptoms of a patient with Parkinson’s disease are better controlled. The company plans to launch Ongentys later this year.

“The FDA approval of Ongentys represents an important new treatment option for people with Parkinson’s disease,” said Robert A. Hauser, M.D., Professor of Neurology and Director, University of South Florida Parkinson’s Disease and Movement Disorders Center. “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.”

Comment: Ongentys was EU approved in July 2016.