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Emerging Data on ND0612 Infusion System for Parkinson Disease

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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