Ono's Ongentys approved in Parkinson's
Japan’s Ono Pharmaceutical (TYO: 4528) has received a manufacturing and marketing approval of Ongentys (opicapone) Tablets 25mg, a catechol-O-methyltransferase (COMT) inhibitor (COMTi), in its home country.
The approval is for the improvement of the end-of-dose motor fluctuations, or wearing-off phenomenon, in Parkinson's disease, in combination with levodopa–carbidopa or levodopa– benserazide hydrochloride.
This approval is mainly based on the results of a multi-center, placebo controlled, randomized, double-blind, parallel group study and an open-label, uncontrolled, long-term extension study conducted in Japan in patients with Parkinson's disease with wearing-off phenomenon which is treated with levodopa and a DOPA decarboxylase inhibitor.
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