Continuous Subcutaneous Apomorphine Infusion (CSAI) and TOLEDO Study in Parkinson Disease

EP: 1.Off Fluctuations in Parkinson Disease

EP: 2.Adjusting and Changing Treatment Regimens in Parkinson Disease

EP: 3.Recognition of Off Episodes in Parkinson Disease

EP: 4.Conversations About Off Time In Patients With Parkinson Disease

EP: 5.Advanced Treatment Options in Parkinson Disease

EP: 6.Adjunctive Treatments and Apomorphine for Treatment of Parkinson Disease

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EP: 7.Continuous Subcutaneous Apomorphine Infusion (CSAI) and TOLEDO Study in Parkinson Disease

EP: 8.CSAI and INFUS-ON Study for Treatment of Parkinson Disease

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CSAI Pharmacokinetics and Clinical Studies

Pharmacokinetics of CSAI vs Other Formulations:

• Rapid absorption with detectable plasma levels within 10 minutes
• Continuous infusion maintains stable plasma concentrations
• Avoids first-pass metabolism
• Half-Life (T1/2) of approximately 40 minutes
• More consistent plasma levels compared with intermittent injections or oral formulations
• Circumvents gastrointestinal absorption issues

TOLEDO Study Results:

• TOLEDO is a 12-week, double-blind, randomized, placebo-controlled phase 3 trial.
• Primary end point: Change in daily off time
  • CSAI: 2.47-hour reduction vs 0.58-hour for placebo (P < .0001)
• Secondary end points:
  • Increased on time without troublesome dyskinesia
  • Improved Unified Parkinson's Disease Rating (UPDRS) motor scores
  • Enhanced quality-of-life measures
• Safety profile:
  • Common adverse events (AEs): injection site reactions, nausea, somnolence
  • Generally mild to moderate in severity
  • Low discontinuation rate due to AEs

52-Week Open-Label Extension Results:

• Sustained efficacy in off time reduction over long-term use
• Stable levodopa equivalent dose requirements
• No new safety concerns identified
• Progressive improvement in some efficacy parameters
• Stable dyskinesia rates
• High patient retention suggesting acceptable tolerability