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ND0612 (NeuroDerm Ltd, Rehovot, Israel) is an investigative subcutaneous (SC) drug delivery system that provides minimally invasive, continuous infusion of liquid levodopa/carbidopa for the treatment of Parkinson’s disease with movement fluctuations (PD) patients
.
Previous studies have shown that ND0612 can provide a stable plasma levodopa concentration, significantly reduce the daily withdrawal time, and increase the start-up time without obvious dyskinesia
.
Werner Poewe and others of Medical University Innsbruck, Austria, explored the long-term safety and tolerability of ND0612 in 12 months of treatment, with particular attention to infusion site reactions (ISRs), which are usually related to SC administration
.
.
They included 214 enrolled patients, of whom (24-hour SC infusion: n = 90; 16-hour SC infusion: n = 124), and 120 (56%) completed 12 months of treatment
.
The main reasons for the suspension of the study were consent withdrawal (19.
6%) and adverse events (17.
3%)
.
After program revision and retraining, the suspension rate dropped from 49% to 29%
.
For PD patients treated with levodopa/carbidopa, system safety is typical
.
.
Most patients experienced reactions at the infusion site, especially nodules (30.
8%) and hematomas (25.
2%).
Most of these reactions were judged to be mild to moderate, and only 10.
3% of participants led to discontinuation of the drug
.
The important significance of this study lies in: The subcutaneous injection of levodopa/carbidopa continuous infusion of ND0612 is generally safe, and the typical infusion site reaction of SC administration is the main adverse event
.
Original Source:
Poewe W, Stocchi F, Arkadir D, et al.
Subcutaneous Levodopa Infusion for Parkinson's Disease: 1 ‐Year Data from the Open‐Label BeyoND Study.
Subcutaneous Levodopa Infusion for Parkinson's Disease: 1 ‐Year Data from the Open‐Label BeyoND Study.
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