Benzinga | Sep 11, 2020 11:37AM EDT

Neurocrine Biosciences Highlights Presentation Of New Data Showing Efficacy Of FDA-Approved Once-Daily ONGENTYS (opicapone) in Patients with Parkinson's Disease at the MDS Virtual Congress 2020

Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today announced new data from two post-hoc analyses of Phase III data, demonstrating that once-daily ONGENTYS(r) (opicapone) capsules decreased "off" time and increased "on" time without troublesome dyskinesia as an add-on therapy to levodopa/carbidopa in patients with Parkinson's disease who experience motor fluctuations. Neurocrine Biosciences also presented real-world data showing the increased burden motor fluctuations have over time on Parkinson's disease patients and the healthcare system through significantly more hospitalizations and emergency room visits. These data are among several studies and analyses of ONGENTYS being presented in collaboration with BIAL at the MDS Virtual Congress 2020 on September 12--16 (www.mdscongress.org/Congress/Registration.htm).



ONGENTYS, approved by the U.S. Food and Drug Administration in April 2020, is the first and only once-daily catechol-O-methyltransferase (COMT) inhibitor approved as an add-on to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes and will be available to wholesalers in September.

"As Parkinson's disease progresses and treatment with levodopa/carbidopa begins to wear off between treatment doses, many patients begin to experience increased motor fluctuations," said Robert A. Hauser, M.D., Professor of Neurology and Director, University of South Florida Parkinson's Disease and Movement Disorders Center. "The Phase III post-hoc data analyses demonstrated the benefit of adding once-daily ONGENTYS to levodopa/carbidopa in patients with Parkinson's disease who have motor fluctuations. Patients with Parkinson's disease now have a new treatment option to help provide more control of motor symptoms."

Data from a pooled post-hoc, sub-group analysis of Phase III studies demonstrated that ONGENTYS 50 mg significantly reduced "off" time by more than an hour compared to placebo when used as an add-on treatment in patients with Parkinson's disease treated with levodopa/carbidopa plus placebo at baseline (109.2 minutes for ONGENTYS 50 mg [n=67] vs. 40.3 minutes for placebo [n=59]; p=0.0161).

In a separate post-hoc analysis, ONGENTYS significantly increased absolute "on" time by approximately one additional hour compared with entacapone (124 minutes [n=50] vs. 60 minutes [n=47]; p=0.0344) when used as the first COMT inhibitor add-on therapy to levodopa/carbidopa in patients with Parkinson's disease recently diagnosed with motor fluctuations.

"These data analyses demonstrated the benefit of adding once-daily ONGENTYS to levodopa/carbidopa earlier in the treatment regimen of patients with Parkinson's disease. In addition to decreasing 'off' time the data also show that ONGENTYS significantly increased 'on' time compared to an older COMT inhibitor to help control motor fluctuations in patients with Parkinson's disease," said Eiry W. Roberts, MD, Chief Medical Officer, Neurocrine Biosciences. "We are looking forward to bringing ONGENTYS to patients as a new add-on treatment option as data from our real-world study show that the debilitating symptoms of Parkinson's disease result in more hospitalizations and emergency room visits, impacting the healthcare system in the U.S."

Neurocrine Biosciences also presented real-world data from a retrospective medical chart review of adult patients with Parkinson's disease who began experiencing motor fluctuations while taking levodopa. Of the 310 patients included in the review, 117 (38%) had a history of motor fluctuations of ? 2 years. Data show that emergency department visits were significantly more frequent in patients with Parkinson's disease with a longer history of motor fluctuations (?2 years) compared to patients with a shorter history (13% [n=15] vs. 3% [n=5]; P<0.001). Similarly, hospitalizations were significantly more frequent in patients with a longer history of motor fluctuations (15% [n=18] vs 6% [n=12], P<0.01). Among patients who were hospitalized, the mean length of stay was shorter in patients with motor fluctuations ?2 years versus patients with motor fluctuations <2 years, but the difference was not statistically significant (0.5 vs 1.1 days; P>0.05).