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Neurocrine : FDA Approves Ongentys As Add-On Treatment For Parkinson's Disease

Neurocrine Biosciences Inc. (NBIX) said that the U.S. Food and Drug Administration has approved once-daily oral Ongentys or 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.

Parkinson's disease is a chronic, progressive and debilitating neurodegenerative disorder. Parkinson's disease is caused by low dopamine levels produced in the brain. Dopamine helps transmit signals between the areas of the brain that control all purposeful movements, including talking, walking and writing.

As Parkinson's disease progresses, dopamine production steadily decreases, resulting in increased problems with motor symptoms including slowed movement, tremor, rigidity, impaired posture and balance, and difficulty with speech and writing.

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