Opinion
Video
Emerging Data on ND0612 Infusion System for Parkinson Disease
Author(s):
Panelists discuss how ND0612, another subcutaneous infusion of levodopa currently under FDA review, performs in terms of formulation, efficacy, safety, and quality of life based on the phase 3 BouNDless study.
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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
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