Valeritas Receives FDA Clearance to Market Its V-Go Disposable Insulin Delivery Device and Plans to Launch in 2011

Medical technology manufacturer Valeritas announced earlier this month that it received FDA clearance to market its V-Go Disposable Insulin Delivery Device, which delivers basal-bolus therapy for adults with diabetes. From the onset of its development, the V-Go was designed with the type 2 patient in mind. We think of the V-Go like a substitute for vials/syringes and pens more than as a pump. The non-electronic, mechanical device automatically administers insulin at a preset basal rate over 24 hours (after which time the device stops and must be replaced), and users can also deliver two-unit boluses by a manual two-step process. While the V-Go is approved for “adult patients requiring insulin,” Valeritas will be targeting this new device primarily to those with type 2 diabetes because the preset basal rates are appropriate for those who do not need to vary their basal rates, and because the two-unit boluses may not be flexible enough for many people with type 1 diabetes. The V-Go will be available in three different preset basal rates, reflecting basal delivery of either 20, 30, or 40 units per day, with each version allowing up to 36 additional units for on-demand bolusing, i.e., up to 18 pushes daily, at which point the device has a “lock-out” feature which signals patients that no more boluses can be given. Effectively, the V-Go allows for the delivery of up to a total of 56, 66, or 76 units of insulin per day, depending on the basal rate, which covers approximately 70% of people with type 2 diabetes currently on insulin therapy. The V-Go weighs roughly one ounce when the reservoir is full; by comparison, Insulet's first-generation OmniPod weighs 1.2 ounces when full. The V-Go's dimensions (2.4” x 1.3” x 0.5”) are slightly smaller than the current OmniPod's (2.4” x 1.6” x 0.7”). Insertion is with a 30-gauge stainless steel needle; the device can exert high pressures through the stainless steel needle, which should eliminate or largely reduce the risk of occlusions.

In our view, the major advantages of Valeritas' device are its simplicity, discretion, and convenience: an automatic preset basal rate (without the need for a hand-held controller), and mechanical bolusing that can be done through the patients' clothing (without the need to keep track of pens or syringes, an obstacle that leads many patients to administer insulin only at home). As it is fully mechanical, this could be an advantage as long as it is easy to change; we look forward to hearing how patients and healthcare providers like it. Given the potential market for Valeritas' versatile product, much will ride on reimbursement decisions for fast-acting insulins and for the device itself. We look forward to hearing more about the V-Go. --KC