Neurocrine Biosciences announced that the Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for opicapone, an investigational once daily selective catechol-O-methyltransferase (COMT) inhibitor, for adjunctive treatment to levodopa/carbidopa in patients with Parkinson disease experiencing OFF episodes.
Opicapone works by decreasing the conversion rate of levodopa into 3-O-methyldopa thus prolonging the clinical effects and availability of levodopa in patients. The NDA is supported by data from 38 clinical studies, including two phase 3 studies (BIPARK-1 and BIPARK-2) that showed opicapone significantly reduced OFF time without troublesome dyskinesia. Both studies evaluated opicapone as an adjunct to levodopa therapy in patients with Parkinson disease and motor fluctuations. The primary end point was the change from baseline in absolute OFF time, as assessed by patient diaries.
BIPARK-1 was a double blind, placebo and active controlled study in which 600 patients were randomized to receive once daily opicapone 5mg (n=119), 25mg (n=116), 50mg (n=115), placebo (n=120) or entacapone 200mg (n=120) for 14 to 15 weeks. Findings from the study revealed a significant OFF time reduction for patients receiving opicapone 50mg compared with placebo (-116.8 minutes vs -56 minutes, respectively). Treatment with opicapone 50mg was found to be noninferior to entacapone (mean difference in change from baseline: −26.2 minutes, −63.8 to 11.4; P =.0051).
BIPARK-2 was a double blind, placebo controlled study in which 400 patients were randomized to receive once daily opicapone 25mg (n=125), 50mg (n=147), or placebo (n=135) for 14 to 15 weeks. Results demonstrated a significant OFF time reduction for patients receiving opicapone 50mg compared with placebo (-124 minutes vs -64.5 minutes, respectively).
A Prescription Drug User Fee Act (PDUFA) target date for the opicapone NDA has been set for April 26, 2020.
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