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Clinical Data With Foscarbidopa/Foslevodopa CSCI in Parkinson Disease

Panelists discuss how phase 3 clinical trials demonstrated the efficacy, safety, and quality of life improvements associated with continuous subcutaneous foscarbidopa/foslevodopa in both short-term and long-term studies.

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Summary of Phase 3 Clinical Trials for Continuous Subcutaneous Foscarbidopa/Foslevodopa

12-Week Randomized, Double-Blind Trial

Efficacy

  • Significant reduction in OFF time compared to placebo (primary end point)
  • Meaningful increase in ON time without troublesome dyskinesia
  • Improved UPDRS motor scores during ON periods
  • Greater proportion of patients achieved ≥1 hour reduction in daily OFF time
  • Effects observed as early as week 1 and maintained throughout the trial

Safety

  • Most common adverse events: infusion site reactions, nausea, dyskinesia
  • Majority of infusion site reactions were mild to moderate in severity
  • Low discontinuation rate due to adverse events (~5%)
  • No clinically significant changes in laboratory values
  • No unexpected safety signals compared to oral levodopa/carbidopa
  • No serious device-related complications

Quality of Life

  • Significant improvement in PDQ-39 scores (Parkinson’s Disease Questionnaire)
  • Enhanced patient-reported daily functioning
  • Improved sleep quality measures
  • Reduced caregiver burden
  • High treatment satisfaction scores

52-Week Open-Label Extension Trial

Efficacy

  • Sustained reduction in OFF time throughout the extended treatment period
  • Maintained improvement in ON time without troublesome dyskinesia
  • Stable UPDRS motor scores, suggesting durable symptomatic control
  • Reduced need for rescue medication compared to baseline
  • No evidence of tolerance development

Safety

  • Consistent safety profile with the 12-week study
  • Declining incidence of infusion site reactions over time, suggesting adaptation
  • No new safety concerns with prolonged exposure
  • Manageable and predictable adverse event profile
  • Low rate of serious adverse events related to treatment
  • Device-related complications remained infrequent

Quality of Life

  • Sustained improvement in PDQ-39 scores through 52 weeks
  • Maintained positive impact on activities of daily living
  • Persistent improvement in sleep quality
  • Stable or improved non-motor symptom scores
  • High retention rate, indicating acceptable patient tolerability and satisfaction

Clinical Implications

  • Continuous subcutaneous foscarbidopa/foslevodopa provides a viable alternative for advanced Parkinson disease patients with motor fluctuations
  • The prodrug formulation allows for stable plasma levodopa levels, potentially addressing the limitations of oral therapy
  • Benefits appear durable over the long-term with a manageable safety profile
  • May be particularly beneficial for patients with refractory motor fluctuations or those unsuitable for deep brain stimulation
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