www.fdanews.com/articles/196849-neurocrine-biosciences-grabs-fda-approval-for-parkinsons-treatment-ongentys
Neurocrine Biosciences Grabs FDA Approval for Parkinson’s Treatment Ongentys
April 28, 2020
The FDA approved Neurocrine Biosciences’ Ongentys (opicapone) 25 mg and 50 mg as an add-on treatment to levodopa/carbidopa for patients with Parkinson’s disease experiencing “off” episodes.
The approval was based on the results of 38 clinical studies, including two phase 3 trials of more than 1,000 Parkinson's patients. Data from both trials showed that Ongentys 50 mg significantly reduced “off” time compared to the placebo.
Neurocrine plans to launch Ongentys later this year.