PALM BEACH GARDENS, Fla.--(BUSINESS WIRE)--TD Solutions announced today that they have initiated development of Levellor™ HypoSpray Insulin for insulin-dependent diabetics. More than 6 million Americans use insulin in some form and that number will continue to rise. TD Solutions is initiating approval of human insulin 100 & 200 IU/mL delivered via its HypoSpray® system and is seeking a partner interested in licensing this new product entry in a market that is challenged by cost constraints and periodic supply shortages. This system does not employ needles or an injector device. The Insulin is formulated into a liquid carrier composed of substances that are Generally Regarded As Safe (“GRAS”). The formula is absorbed across intact skin, delivering the Insulin as quickly as a hypodermic injection but without the risk and fear of the needle. The spray-on Insulin format has been tested in a preliminary Phase 0 clinical trial and the formula is optimized to perform with injectible insulin products. Due to the elimination of the hypodermic auto-injector, the resulting dose form is so easy to use, a child can self-administer it. TD Solutions will be submitting the results of the preliminary Phase 0 study for peer-review in the near future with a view to publication. The Company will meet for guidance with FDA CDER Office of Generic Drugs (OGD) on the steps for approval of this product and will submit chemistry, manufacturing and controls data as a part of the briefing book. The Company believes that approval could come as early as 2020.
About TD Solutions
TD Solutions is committed to advancing the science of Sprayed-On Pharmaceuticals using its patented system. TD Solutions’ proprietary system enables medications as large as Insulin to be delivered directly through the skin, for systemic or localized application, utilizing its rapid acting, patchless, spray-on technology. The company’s technology is flexible enough to be applicable to a very wide range of compounds for pharmaceutical or cosmetic use. No other company can offer similar, consumer friendly, dosing flexible solutions. https://youtu.be/hYnOl0b5KeE Visit: www.tdsc.us
