Valeritas Holdings, Inc. Presents Positive H-Patch CBD Study Data as Late-Breaking Presentation at the American Epilepsy Society 2019 Annual Meeting
December 09, 2019 at 07:00 am EST
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Valeritas Holdings, Inc. announced positive data from its preclinical pharmacokinetic (PK) study of cannabidiol (CBD) subcutaneous infusion was presented as a late-breaking poster presentation on Sunday, December 8 at the American Epilepsy Society 2019 Annual Meeting in Baltimore, Maryland. The Company believes this study represents the first report of CBD isolate delivered via subcutaneous infusion in any preclinical model. In the poster presentation titled Therapeutic Plasma Levels of Cannabinoid (CBD) in Dogs Delivered Via h-Patch Subcutaneous Infusion, the Company showcased for the first time data from both 40mg and 76mg of CBD isolate delivered over 24 hours with the h-Patch technology. Both dosages demonstrated rapid and robust absorption and distribution, followed by prolonged elimination with near steady-state levels still detectable 24 hours after completion of h-Patch infusion, or 48 hours in total. The study demonstrated that subcutaneous infusion of both 40mg and 76mg of CBD with the h-Patch provided peak plasma levels on par with published human dose-normalized plasma concentrations from a single oral administration of 300mg CBD, but showed dramatically higher plasma levels than oral administration at 24 and 48 hours. Oral CBD solutions have very low bioavailability in humans, in the range of 6%-10%, and concerns linger over the long-term effect CBD has on the liver as a result of exposure to toxic metabolites. The h-Patch system provides a continuous basal delivery rate over a period of 24 hours and maximizes the therapeutic result by avoiding the first-pass effect and eliminating peak/trough variations of drug exposure. Subcutaneous infusion of CBD via the h-Patch may offer several distinct advantages over oral dosing including the ability to achieve therapeutic drug concentrations with a fraction of the overall dose, significantly prolonged half-life (versus single oral administration), minimization of the variation in CBD metabolism in the general population, and a dramatic reduction in the overall amount of drug metabolized by the liver. These features may contribute to a dramatically improved risk-reward profile for a CBD isolate therapeutic and could open the door to reliable, uniform dosing.
Valeritas Holdings, Inc. is a United States-based medical technology company. The Company's product, V-Go Wearable Insulin Delivery device (V-Go), is a wearable, basal-bolus insulin delivery device for adult patients requiring insulin that enables patients to administer a continuous preset basal rate of insulin over 24 hours. V-Go is a small wearable and completely disposable insulin delivery device that a patient adheres to his or her skin every 24 hours. V-Go enables patients to closely mimic the body's normal physiologic pattern of insulin delivery throughout the day and to manage their diabetes with insulin without the need to plan a daily routine around multiple daily injections. It has developed V-Go utilizing its h-Patch platform as a patient-focused solution to address insulin therapies. Its h-Patch platform facilitates the subcutaneous delivery of injectable medicines to patients across a range of therapeutic areas.
VALERITAS HOLDINGS, INC. 