Results from key Phase 3 studies confirm the clinical efficacy and overall safety of opicapone
BIAL is presenting 11 research posters at the 19th International Congress of Parkinson's Disease and Movement Disorders (June 14–15, San Diego, CA). 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. Bial’s marketing authorisation application is currently under review at the European Medicines Agency.
Professor Joaquim Ferreira, Professor of Neurology and Clinical Pharmacology at the University of Lisbon and lead investigator of BIPARK-I said:
Parkinson’s disease places a substantial burden on patients and society. Opicapone represents a valuable addition to the therapies available for the management of motor fluctuations in PD.
The research posters cover key trials including:
- Results from BIPARK-I confirming that opicapone is effective at reducing OFF-time with a favourable 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.
- Results from 286 patients enrolled into the open-label 1-year extension of BIPARK-II confirming that long-term use of opicapone is considered safe and well tolerated.
- Pooled results from the double-blind phase of BIPARK-I and BIPARK-II (509 patients in the pooled efficacy set; 750 in the pooled safety set) confirming that opicapone is effective in reducing OFF-time, without increasing ON-time with troublesome dyskinesia; improves motor fluctuations in levodopa-treated patients regardless of concomitant dopamine agonist or monoamine oxidase type B inhibitors use; is safe and well-tolerated in the whole trial population and in the subset of patients over 70 years; is not associated with relevant electrocardiographic or hepatic adverse events.
The continued development of opicapone reflects BIAL’s commitment to discover, develop and provide new therapeutic solutions to patients.