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CSAI and INFUS-ON Study for Treatment of Parkinson Disease

Panelists discuss how the recently FDA-approved SPN-830 apomorphine infusion pump demonstrated significant efficacy in reducing off time and improving motor function in the INFUS-ON study, with physicians expressing optimistic views about both the US and European clinical trial results.

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SPN-830 FDA Approval and INFUS-ON Study

INFUS-ON Study Design:

  • Phase 3, open-label study in patients with Parkinson disease with motor fluctuations
  • Treatment duration of 12 months
  • Primary end points: safety and tolerability
  • Secondary end points: off time reduction, on time change, UPDRS scores

Efficacy Results:

  • Significant reduction in daily off time (2.3 hours)
  • Increase in on time without troublesome dyskinesias
  • Improvement in motor function (UPDRS Part III scores)
  • Benefits maintained throughout 12-month period
  • Positive impact on quality-of-life measures

Safety Results:

  • Most common adverse events (AEs): injection site reactions, nausea, dyskinesia
  • Manageable safety profile with appropriate monitoring
  • Low rate of serious AEs
  • No significant cognitive or psychiatric adverse effects

Physician Impressions:

  • Comparable efficacy results between TOLEDO and INFUS-ON studies
  • Consistent safety profile across studies
  • Meaningful clinical improvements in motor fluctuations
  • Results generalizable to real-world clinical practice
  • Need for dedicated support for infusion initiation and management

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