ONGENTYS®▼ (opicapone) demonstrates significant efficacy in the early stages of motor fluctuations in PD patients

• BIAL released opicapone data from seven abstracts at the European Academy of Neurology (EAN) virtual congress
• Data from BIPARK-I and II post-hoc analysis show opicapone 50 mg is effective in patients with Parkinson’s disease (PD) regardless of duration of motor fluctuations
• Additional data suggest potential for opicapone as first-line adjunctive levodopa/ DDCI (DOPA decarboxylase inhibitor) treatment in patients with motor fluctuations, who cannot be stabilised by levodopa/ DDCI alone

New data was presented at the 6th congress of the European Academy of Neurology, demonstrating the potential for ONGENTYS® (opicapone) to help a wide range of Parkinson’s patients with motor fluctuations.

A new post-hoc analysis of two large multinational trials (BIPARK-I and II1,2) shows that opicapone, a once-daily COMT (catechol-O-methyltransferase) inhibitor, demonstrated efficacy in both patients recently diagnosed with motor fluctuations (duration of motor fluctuations up to 1 year) and long-standing motor fluctuators (duration of more than 1 year) as measured by changes from baseline in absolute OFF- and ON-time versus placebo.3 COMT inhibitor treatment is appropriate for patients taking levodopa where there is evidence of motor fluctuations such as ‘wearing-off’. This can occur earlier in the course of the illness than was previously recognised.4

Dyskinesia was the most frequently reported ‘at least possibly’ related treatment- emergent adverse event. Patients receiving opicapone 50 mg had a lower incidence of dyskinesia if they were recently-diagnosed versus long-standing motor fluctuators.3

Professor Joaquim Ferreira, Professor of Neurology and Clinical Pharmacology at the University of Lisbon, said, “Opicapone demonstrated efficacy in both recently-diagnosed and long-standing motor fluctuations. This reinforces the benefit of opicapone regardless of duration of motor fluctuations and suggests it could be considered as soon as end-of-dose motor fluctuation commences.”

The potential for earlier use of opicapone in some patients was also supported by additional data released at EAN demonstrating efficacy in patients with motor fluctuations treated with levodopa/DDCI-only (that is, without use of dopamine agonists or MAO-B inhibitors) in a posthoc analysis of BIPARK-I and II.5

“BIAL is committed to providing new therapeutic solutions and is proud of the wealth of
opicapone data being released at EAN” said António Portela, CEO of BIAL. “Our focus is on
providing an effective option for patients on levodopa who may be experiencing motor
fluctuations at any stage of treatment. These data, along with real-world evidence from the
recently published OPTIPARK study, also presented at EAN, show the potential for opicapone
in clinical practice.”

  • Data on opicapone at the EAN were presented in 11 abstracts, seven of these were sponsored by
  • EPO1224: Ebersbach G et al. Efficacy and Safety of Opicapone in Parkinson’s Disease
    Patients According to Duration of Motor Fluctuations: Post-Hoc Analysis of BIPARK-I
    and II3
  • EPR1141: Ferreira JJ et al. Opicapone as First-Line Adjunctive Levodopa Treatment in
    Parkinson’s Disease Patients with Motor Fluctuations: Findings from BIPARK-I and II
    Combined Post-Hoc Analysis5
  • EPO1182: Antonini A et al. Super-Responders to Opicapone Adjunct Treatment to
    Levodopa in Parkinson’s Disease Patients with Motor Fluctuations: Combined Post-Hoc
    Analysis of BIPARK-I and II
  • EPR2111: Reichmann H et al. Opicapone in Clinical Practice in Parkinson’s Disease
    Patients with Motor Fluctuations: Findings from the OPTIPARK Study
  • EPO3148: Rascol O et al. Efficacy of Opicapone in Patients with Parkinson’s Disease
    with Levodopa Dose Reduction: A Pooled Post-Hoc Analysis of BIPARK-I and II
  • EPO3141: Poewe W et al. Change in OFF-/ON-Time After Switching from Double-Blind
    Entacapone or Placebo to Open-Label Opicapone in Patients who Ended the 1-Year
    BIPARK-I Extension Study on Opicapone 50-mg
  • EPO3175: Tolosa E et al. Changes Activities of Daily Living and Motor Function in
    Patients Switching from Entacapone or Placebo to Opicapone who Ended BIPARK-I
    Extension on Opicapone 50-mg

For more information on BIAL:

1. Ferreira JJ, et al. Lancet Neurol 2016;15(2):154–165.
2. Lees A, et al. JAMA Neurol. 2017;74(2) 197-206
3. Ebersbach G, et al. EAN abstract 2020.
4. Jenner P. Transl Neurodegener 2015;4:3.
5. Ferreira JJ, et al. EAN abstract 2020.
6. Ongentys® EU SMPC. Last updated 22/04/2020.