Continuous Subcutaneous Apomorphine Infusion for Treatment of Parkinson Disease

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Apomorphine Infusion Therapy for Parkinson Disease: Clinical Evidence Summary

FDA Approval Update

A continuous subcutaneous apomorphine infusion (CSAI) pump has recently received FDA approval for managing motor fluctuations in Parkinson disease (PD), complementing the established subcutaneous apomorphine injection (SPN-830).

Key Clinical Trials

TOLEDO Study

• Design: Randomized, double-blind, placebo-controlled, multicenter phase 3 trial
• Population: PD patients with motor fluctuations despite optimized oral/transdermal therapy
• Primary Outcome: Significant reduction in OFF time compared to placebo
• Secondary Benefits: Improved ON time without troublesome dyskinesia and quality of life measures
• Safety Profile: Most common adverse events included infusion site reactions, nausea, and somnolence

Infus-ON Study

• Design: Long-term, open-label extension study following TOLEDO
• Duration: Examined efficacy and safety over extended treatment periods
• Key Findings: Sustained reduction in OFF time and improvement in motor symptoms
• Long-Term Tolerability: Demonstrated acceptable long-term tolerability with consistent safety profile
• Patient Adherence: Generally good compliance with therapy over extended periods

Clinical Implications

CSAI provides an additional treatment option for PD patients with motor fluctuations inadequately controlled by conventional oral therapy, potentially improving quality of life and functional status through more consistent dopaminergic stimulation.