New data released at the International Congress of Parkinson’s Disease and Movement Disorders

Data released at the International Congress Of Parkinson's Disease and Movement Disorders

New data has been released at the International Congress of Parkinson’s Disease and Movement Disorders (MDS) further supporting the efficacy and tolerability of ONGENTYS®▼ (opicapone) observed in pivotal Phase III studies. Opicapone is a once-daily catechol-O-methyltransferase (COMT) inhibitor, approved for the treatment of end-of-dose motor fluctuations in adult PD patients taking levodopa.

Data from the OPTIPARK study demonstrated consistently low incidence of treatment related adverse events in clinical practice from the third week onwards in Parkinson’s disease (PD) patients with motor fluctuations treated with opicapone (as an adjunct therapy to levodopa)1

Further evaluation of data from two large multinational trials (BIPARK-I and II) demonstrated opicapone’s potential for patients in the early stages of motor fluctuations and its capacity to reduce OFF-time when used as a first COMT add-on therapy to levodopa/DDCI2,3,4,5

Additional data from BIPARK-I and II showed that treatment with opicapone leads to a substantial reduction in morning OFF-time in PD patients with motor fluctuations compared with entacapone6

Finally, a review of home-diary data of 235 patients treated with 50mg of opicapone or entacapone in the BIPARK-I 7 trial showed that treatment with opicapone led to a greater increase in the proportion of patients who woke up in ON-status than treatment with entacapone (12.2% increase from baseline for opicapone compared with 7.5% for entacapone).

Reduction in morning OFF-time was two-fold greater for opicapone versus entacapone (20%/h vs 10%/h).6

Speaking about the new data from the International Congress of Parkinson’s Disease and Movement Disorders, Professor Heinz Reichmann, Professor of Neurology at the University of Dresden, said: “Opicapone has demonstrated its potential in a real-life setting, offering a generally well tolerated adjunct to levodopa for Parkinson’s patients with motor fluctuations, with low incidence of treatment-related adverse events over time. Alongside the efficacy data published earlier this year, this is valuable additional information for clinicians considering opicapone use in routine clinical practice.”

Professor Soares da Silva, Director of Research & Development of Bial, said: “The amount of data we are presenting at MDS is indicative of our ongoing commitment to and investment in Parkinson’s Disease. Motor fluctuations can have a considerable impact on quality of life for people with Parkinson’s and our focus is on offering effective solutions with manageable tolerability. These new data demonstrate the potential for opicapone for use in a range of patients experiencing motor fluctuations, regardless of the point at which they occur.”

References

1 Lees A, et al. Onset of Drug-Related Adverse Events in Parkinson’s Disease Patients with Motor Fluctuations Treated with Opicapone in Clinical Practice: OPTIPARK Post-Hoc Analysis. MDS 2020 Abstract #1029.

2 Lees A, et al. Efficacy and safety/tolerability of opicapone in catechol-O-methyltransferase inhibitor-naïve Parkinson’s disease patients recently diagnosed with motor fluctuations. MDS 2020 Abstract #1028.

3 Antonini A, et al. Efficacy of opicapone in different levodopa-containing treatment regimens in Parkinson’s disease patients with motor fluctuations. MDS 2020 Abstract #973.

4 Ebersbach G, et al. Opicapone’s added benefit as a first-line adjunctive therapy to levodopa and when used promptly in the motor fluctuations spectrum of Parkinson’s disease: a post-hoc analysis of BIPARK-I and II. MDS 2020 Abstract #994.

5 Ferreira JJ, et al. Efficacy of opicapone compared to entacapone in catechol-O-methyltransferase inhibitor-naïve Parkinson’s disease patients recently diagnosed with motor fluctuations: a post-hoc conservative analysis. MDS 2020 Abstract #998.

6 Videnovic A, et al. Effect of opicapone and entacapone on early morning-OFF pattern in Parkinson’s disease patients with motor fluctuations. MDS 2020 Abstract #1071.

7 Ferreira JJ, et al. Opicapone as an adjunct to levodopa in patients with Parkinson’s disease and end-of-dose motor fluctuations: a randomised, double-blind, controlled trial. Lancet Neurol. 2016;15(2):154–65.

8 Lees A, et al. Opicapone as Adjunct to Levodopa Therapy in Patients With Parkinson Disease and Motor Fluctuations A Randomized Clinical Trial. JAMA Neurol. 2017;74(2):197–206

9 Ongentys® EU SmPC. Last updated 22/04/2020.

10 Reichmann H, et al. Effectiveness and safety of opicapone in Parkinson’s disease patients with motor fluctuations: the OPTIPARK open-label study. Transl Neurodegener. 2020;9;1–9.

11 Kouli A, et al. Parkinson’s Disease: Pathogenesis and Clinical Aspects. 2018 Ch 1.