The Food and Drug Administration (FDA) has approved Ongentys® (opicapone; Neurocrine Biosciences) as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson disease (PD) experiencing “off” episodes.
Opicapone is a selective and reversible inhibitor of catechol-O-methyltransferase, the major metabolizing enzyme for levodopa. By blocking the COMT enzyme, opicapone prevents the breakdown of levodopa, increasing its exposure and subsequently prolonging the clinical effects and availability of levodopa in PD patients. The treatment is administered once-daily at bedtime.
The approval was based on data from 2 double-blind, phase 3 parallel-group, placebo- and active-controlled (BIPARK-1), or placebo-controlled (BIPARK-2) studies of 14-15 week duration. All study patients were on a stable regimen of levodopa/ DOPA decarboxylase inhibitors (alone or in combination with other PD medications).
In BIPARK-1, patients (N=600) were randomized to receive 3 different doses of opicapone; the intention-to-treat population included patients treated with opicapone 50mg once daily (n=115) or placebo (n=120). Results showed that the 50mg dose significantly reduced mean absolute OFF-time (primary end point) compared with placebo (placebo-subtracted difference: -1.01 hours [95% CI, -1.620 to -0.407]; P =.002).
In BIPARK-2, patients (N=427) were randomized to treatment with either 1 of 2 doses of opicapone once daily or placebo; the intention-to-treat population included patients treated with opicapone 50mg once daily (n=147) or placebo (n=135). Findings from the study showed that treatment with opicapone 50mg significantly reduced mean absolute OFF-time (primary end point) compared with placebo (placebo-subtracted difference: -0.91 hours [95% CI, -1.523 to -0.287]; P =.008).
In both studies, increased ON-time without troublesome dyskinesia, a secondary efficacy end point, was observed when compared with placebo.
As for safety, the most common adverse reactions reported in the studies included dyskinesia, constipation, increased blood creatine kinase, hypotension/syncope, and decreased weight.
Ongentys is supplied as 25mg and 50mg capsules. The product is expected to be available later this year.
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