Clinical trials of opicapone

The efficacy and safety of opicapone, a once-daily catechol-O-methyltransferase inhibitor, were based on two clinical trials (Trial 1/ Approved on the basis of evidence from NCT01568073 and Trial 2/NCT01227655), which involved 522 people with Parkinson's disease (PD) whose symptoms were not well controlled on conventional PD therapy, two 12-week trials were conducted in participants with Parkinson's disease (PD) who were receiving the Parkinson's disease medication carbidopa/levodopa and who had inadequate control of their Parkinson's disease symptoms ("off" time).

Participants were randomly selected to receive either Opicapone or placebo capsules once daily, and benefit was assessed by measuring the change from baseline in total daily "rest" time in subjects receiving Opicapone and placebo. The majority of patients experienced improvement in their overall PD status (≥70% as judged by clinicians and patients themselves) 3 months after starting 50mg Opicapone treatment, 59.6% in the comprehensive pivotal study. Dopaminergic therapy is well tolerated in patients with Parkinson's disease and adverse events are expected. 40.5% of patients reported a great or very great improvement in their condition after 3 months of treatment with 50 mg of Opicapone, with significant improvements in UPDRS motor and ADL scores (4.6 and 3.0 points, respectively).

Opicapone has not yet been launched in the country, so it is not covered by medical insurance. The European version of Opicapone’s original drug specifications listed overseasThe price per box of 50mg*90 capsules is around RMB 6,000 (the price may fluctuate due to the exchange rate). There is currently no generic version of Opicapone on the market. For more drug information and specific prices, please consult Yaode’s medical consultant.