PALM BEACH GARDENS, Fla.–(BUSINESS WIRE)–TD Solutions announced today that they have initiated development of Epi Mist™ HypoSpray Epinephrine for allergic reactions. More than 35 million Americans suffer from allergies and that number will continue to rise. Spot shortages of life-saving medication causes anxiety for patients and caregivers.
TD Solutions is initiating accelerated approval of emergency epinephrine 1mg/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 Epinephrine 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 emergency remedy as quickly as a hypodermic injection but without the risk and fear of the needle. The spray-on format will enable continued dosing until relief is experienced and professional assistance obtained. Preliminary data shows a shelf life of 24 months. Due to the elimination of the hypodermic auto-injector, the product is so easy to use, a child can self-administer it. The Company met for guidance with FDA CDER Division of Pulmonary, Allergy and Respiratory Products (DPARP) and has submitted chemistry, manufacturing and controls data. The Company believes that approval could come as early as 2020.
“We have input for our clinical plan and are excited about the possibilities this project presents for safer, more affordable medication for anaphylaxis intervention in patients and in hospital environments,” said company President Kenneth Kirby.
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://www.youtube.com/watch?v=Fm0FQJiDdS4&t=5s Visit: www.tdsc.us
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