Published on June 15, 2015 at 8:56 AM
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.
Source:
http://www.news-medical.net/news/20150615/Clinical-studies-confirm-safety-efficacy-of-opicapone-in-Parkinsone28099s-disease-patients.aspx
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