Emerging Data on ND0612 Infusion System for Parkinson Disease

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Summary of ND0612

Formulation Overview

ND0612 is a novel subcutaneous infusion of levodopa/carbidopa currently under FDA review. This liquid formulation is administered via a small pump system designed to deliver continuous treatment over 24 hours.

Phase 3 BouNDless Study Data

Based on my knowledge cutoff (October 2024), I can provide the following summary of the BouNDless study:

Efficacy

• Demonstrated significant reduction in OFF time compared to oral levodopa/carbidopa immediate release
• Showed improvement in ON time without troublesome dyskinesia
• Provided more consistent plasma levodopa levels compared to oral therapy

Safety Profile

• Most common adverse events were related to infusion site reactions (redness, nodules)
• No new safety signals compared to established levodopa/carbidopa profile
• Generally well-tolerated with manageable adverse effects

Quality of Life Outcomes

• Patients reported improvements in activities of daily living
• Reduced motor fluctuations correlated with better quality of life scores
• Increased independence in daily activities

Medical Professionals’ Impressions

Medical professionals have generally viewed the BouNDless data positively, noting:

• The potential for ND0612 to address the unmet need for continuous dopaminergic stimulation
• Appreciation for a less invasive alternative to surgical interventions like DBS

Recognition of its potential role for patients with refractory motor fluctuations