Continuous Levodopa Delivery with an Intraoral Micropump System: An Open-Label Pharmacokinetics and Clinical Study

Area of Science:

• Neurology
• Pharmacokinetics
• Medical Devices

Background:

• Parkinson's disease (PD) motor complications can be mitigated by continuous levodopa delivery.
• The DopaFuse system is an intraoral micropump delivering levodopa/carbidopa (LD/CD) continuously.

Purpose of the Study:

• To assess the safety, pharmacokinetics, and efficacy of LD/CD delivered via DopaFuse.
• Comparison against intermittent oral LD/CD in PD patients with motor fluctuations.

Main Methods:

• A 2-week, open-label study (NCT04778176) involving 16 PD patients.
• Patients received standard LD/CD, then DopaFuse therapy with optional morning oral dose.
• In-clinic assessments on Day 1 and Day 15, with home use Days 4-14.

Main Results:

• DopaFuse reduced plasma levodopa variability (Fluctuation Index decreased from 2.15 to 1.03, P < 0.0001).
• Significantly reduced OFF time (-1.72 hours, P=0.0004) and increased ON time without dyskinesias (+1.72 hours, P=0.0004).
• No clinically significant adverse events were reported with DopaFuse therapy.

Conclusions:

• Continuous LD/CD delivery via DopaFuse significantly reduces levodopa concentration variability.
• DopaFuse therapy effectively decreases OFF time and is well-tolerated in PD patients.
• The DopaFuse system presents a promising alternative for managing motor fluctuations in Parkinson's disease.