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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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