Valeritas Holdings, Inc. Announces Positive Results from Preclinical Pharmacokinetic Study of Cannabidiol
July 30, 2019 at 07:00 am EDT
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Valeritas Holdings, Inc. announced positive results from a preclinical pharmacokinetic (PK) study of cannabidiol (CBD) subcutaneous infusion with two dosing regimens delivered via its proprietary h-Patch wearable drug delivery device. The Company believes this study represents the first report of CBD delivered through subcutaneous infusion in any preclinical model. Valeritas h-Patch is a drug delivery technology that can facilitate the simple and effective subcutaneous delivery of injectable medicines to patients across a broad range of therapeutic areas. The Company's V-Go is the first FDA-approved product that utilizes the h-Patch technology. To date, more than 20 million V-Go insulin delivery devices have been sold in the United States. The study evaluated CBD delivered over a single 24-hour period using the h-Patch. Two CBD dosage regimens (40mg/24h and 76mg/24h) were tested via the h-Patch, with PK evaluated at time points out to 48 hours from the start of infusion. Both dosages displayed rapid absorption and distribution with CBD levels in blood detected within an hour of the beginning of infusion, followed by prolonged elimination with CBD still detectable 24 hours after completion of h-Patch infusion. Results of the study will be submitted for presentation at a major medical conference in 2019. Oral CBD solutions have very low bio-availability in humans, in the range of 6%-10%, and concerns linger over their long-term effect 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 therapeutic effect by avoiding the first-pass effect and eliminating peak/trough variations of drug exposure. The Company believes 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. 