Neurocrine Biosciences Parkinson's Drug Cleared by FDA

Neurocrine was cleared by the FDA to market its Parkinson's treatment Ongentys, which it says helps curb muscle stiffness, tremors and slow movement.
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Neurocrine Biosciences  (NBIX) - Get Report said the Food and Drug Administration cleared its Parkinson's disease drug Ongentys.

The daily oral treatment can be used along with current Parkinson’s drugs levodopa and carbidopa to treat "off" episodes of the disease. "Off" episodes refer to muscle stiffness, tremors or slow movement.

The drug curbed off episodes in clinical trials. Neurocrine said it would put off shipment of Ongentys until later this year, so it doesn’t interfere with the focus on the coronavirus epidemic.

“The FDA approval of Ongentys provides patients living with Parkinson’s disease 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,” Neurocrine Chief Executive Kevin Gorman said in a statement.

The statement also included comments from Robert Hauser, director of the University of South Florida Parkinson’s Disease and Movement Disorders Center.

“The FDA approval of Ongentys represents an important new treatment option for people with Parkinson’s disease,” he said.

“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.”

Parkinson’s disease is the second most common neurodegenerative disorder in the U.S. after Alzheimer’s, the company said. About one million Americans have Parkinson’s disease.

Neurocrine shares recently traded at $101.78, up 3.7%. The stock has firmed 2% over the past three months, compared with a 13% drop for the S&P 500.