A novel, oral drug that would be added to Parkinson’s disease patients’ regimen of taking levodopa demonstrated significant reduction in reducing the “off-time,” or periods when a medication is not working and Parkinson’s symptoms returns, in phase III trials.
The drug, opicapone (BIA 9-1067), is a catechol-O-methyltransferase (COMT) inhibitor under development by Bial, an pharmaceutical company based in Portugal. Inhibition of COMT is believed to boost the effect of levodopa in Parkinson’s patients with motor fluctuations.
In a host of research papers just presented at the 19th International Congress of Parkinson’s Disease and Movement Disorders in San Diego, 50mg of opicapone given daily reduced absolute off-time by two hours compared to placebo. In addition, it was found to be non-inferior to entacapone (Comtan), another COMT inhibitor already on the market in the United States.
However, opicapone may have an key advantage for patients over entacapone as it is only dosed once per daily compared to entacopone, which is given with each levadopa/carbidopa dose, which can be as many as eight times per day.
Results from Bial’s BIPARK-1 trial also showed that the drug is associated with significant improvements in patient and clinician global impressions of change, in comparison to entacapone, which showed no such large differences in this area compared to placebo.
Pooled results from double-blind phase BIPARK-I and BIPARK-II (509 patients in the pooled efficacy set, and 750 in the pooled safety set) found that opicapone was effective in reducing off-time without increasing on-time with dyskinesia. In addition, results from a one-year, open-label extension of BIPARK-II that enrolled 286 patients found that opicapone demonstrated safety and tolerability over the long-term.
An application for approval of opicapone is currently before the European Medicines Agency, but no application has been submitted to the U.S. FDA.
BIAL is presenting 11 research posters at the 19th International Congress of Parkinson’s Disease and Movement Disorders (June 14-15, San Diego, Calif.). These evaluate the safety and efficacy of opicapone (BIA 9-1067), a novel once-daily catechol-O-methyltransferase (COMT) inhibitor for use as adjunctive therapy in levodopa-treated Parkinson’s disease patients with end of dose motor fluctuations.
Results from BIPARK-I confirming that opicapone is effective at reducing OFF-time with a favorable profile compared to entacapone, and is associated with significant improvements in both patient and clinician global impressions of change, in contrast to entacapone, which showed no significant differences compared to placebo in either assessment.