Session Information
Date: Monday, September 23, 2019
Session Title: Clinical Trials, Pharmacology and Treatment
Session Time: 1:45pm-3:15pm
Location: Agora 3 West, Level 3
Objective: To assess the skin safety and tolerability of 24-hour continuous subcutaneous infusion (CSCI) of ABBV-951.
Background: Therapeutic approaches for advanced Parkinson’s disease (aPD) patients are highly efficacious but their use is hampered by their invasiveness. ABBV-951 is a novel, highly soluble solution of levodopa and carbidopa prodrugs able to deliver the wide range of therapeutic exposures necessary to control motor symptoms in aPD via a minimally invasive CSCI. Dopaminergic therapies for CSCI are available (apomorphine) or in development (ND0612H); however, the onset of uncomfortable skin reactions, which might impact drug absorption and require daily rotation of infusion sets, might affect quality of life and limit their use.
Method: A dose of ABBV-951 equivalent to ~600mg of levodopa and an equal volume of saline were administered in two demarcated (5cm diameter) areas on opposite sides of the abdomen to 33 healthy volunteers, for 10 consecutive days. Infusion sets were changed and reapplied daily on the same skin surface. Systemic and local safety and tolerability were assessed daily. Notable skin reactions were defined a-priori as events normally not associated with predictable reactions from the use of infusion sets (grades ≥D or ≥6 on the Infusion Site Evaluation Scales). Both subjects and raters were blinded to the sides of the abdomen in which ABBV-951 and placebo were infused.
Results: All subjects completed the study. No notable skin reactions were observed for the ABBV-951 site and only one for the placebo site. The most frequently reported skin events were erythema (43%), skin reactions (20%) and infusion site pain (14%). All events were mild or moderate, resolved quickly and showed no differences in incidence between ABBV-951 and placebo.
Conclusion: ABBV-951 was safe, well tolerated and did not cause notable skin reactions at low, yet clinically relevant doses, administered in the same skin area for 10 consecutive days.
To cite this abstract in AMA style:
M. Facheris, X. Qi, C. Locke, M. Rosebraugh, J. Benesh. Lack of Notable Skin Reactions from a Novel Levodopa/Carbidopa Prodrug after 10 Days of Repeated 24-Hour Continuous Subcutaneous Infusion at the Same Administration Site [abstract]. Mov Disord. 2019; 34 (suppl 2). https://www.mdsabstracts.org/abstract/lack-of-notable-skin-reactions-from-a-novel-levodopa-carbidopa-prodrug-after-10-days-of-repeated-24-hour-continuous-subcutaneous-infusion-at-the-same-administration-site/. Accessed November 22, 2024.« Back to 2019 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/lack-of-notable-skin-reactions-from-a-novel-levodopa-carbidopa-prodrug-after-10-days-of-repeated-24-hour-continuous-subcutaneous-infusion-at-the-same-administration-site/