Neurocrine presents data analysis from two Phase III studies of opicapone

Neurocrine announced the presentation of a data analysis from two Phase III studies of opicapone, a novel, once-daily, oral, selective, peripherally-acting catechol-O-methyltransferase inhibitor for the treatment of Parkinson’s disease. The analysis found that treatment with opicapone 50 mg, added to levodopa, resulted in a significant and sustained increase in ON time without troublesome dyskinesia, in Parkinson’s disease patients with motor fluctuations. In addition, more than 60% of patients treated with once-daily opicapone 50 mg achieved greater than or equal to a one-hour increase from baseline in total ON time at week 14/15. The analysis, which included data from more than 900 patients in the double-blind, placebo-controlled Phase III BIPARK-1 and BIPARK-2 studies, was highlighted as an oral session at the 2019 American Academy of Neurology Annual Meeting in Philadelphia. The data presentation highlighted statistically significant increases in absolute ON time without troublesome dyskinesia from baseline to the week 14/15 endpoint in both the BIPARK-1 and BIPARK-2 studies. The improvements in ON time without troublesome dyskinesia were sustained in all patients treated with opicapone in the one-year long-term open-label extension studies, with an average increase from baseline of 2.0+/-2.6 hours in BIPARK-1 and 1.8+/-3.2 hours for BIPARK-2. In addition, a significantly higher percentage of patients treated with opicapone 50 mg had an increase in total ON time of an hour or longer at week 14/15 in both BIPARK-1 and BIPARK-2. Pooled safety data from the double-blind opicapone-treated population showed that 17.4% patients treated with opicapone reported dyskinesia as a treatment-emergent adverse event versus 6.2% in placebo-treated patients. Only 1.9% of opicapone-treated patients discontinued treatment due to a TEAE of dyskinesia and only 0.3% experienced dyskinesia as a serious TEAE. Other TEAEs included constipation, insomnia and dry mouth in opicapone- and placebo-treated patients, respectively.

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