Valeritas Holdings, Inc Announces Positive Results from Preclinical Pharmacokinetic Study of Apomorphine Subcutaneous Infusion Delivered Via H-Patch Wearable Drug Delivery Device
August 05, 2019 at 07:00 am EDT
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Valeritas Holdings, Inc. announced positive results from a preclinical pharmacokinetic (PK) study of apomorphine (Apo) subcutaneous infusion delivered via its h-Patch™ wearable drug delivery device. The company 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. Treatment of advanced Parkinson’s disease (PD) remains challenging, with fluctuations in motor status often resulting in patients becoming severely handicapped. The magnitude and pattern of the motor response to a single dose of subcutaneously administered Apo are qualitatively comparable to that of oral levodopa; however, side effects of oral dosing (nausea, vomiting, etc.) can be problematic. Close to a dozen clinical studies have shown subcutaneous Apo infusions are successful in aborting “off” periods, reducing dyskinesias and improving PD motor scores with the added benefit of a substantial levodopa-sparing effect. However, bulky infusion pumps requiring delivery of relatively large volumes of therapeutics remain a barrier to the development of therapeutic products that are patient and caregiver friendly. The study showed Apo levels were detected in blood within two hours of the beginning of h-Patch™ subcutaneous infusion with a gradual decline after completion of infusion (24-hours). The wearable h-Patch™ represents a patient-friendly subcutaneous delivery mechanism for Apo providing the benefits of a full 24-hour infusion of low dose Apo to eliminate “off” periods and improve motor status without tolerability issues seen with subcutaneous injections.
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 Announces Positive Results from Preclinical Pharmacokinetic Study of Apomorphine Subcutaneous Infusion Delivered Via H-Patch Wearable Drug Delivery Device