CSAI and INFUS-ON Study for Treatment of Parkinson Disease

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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