HypoSpray® products employ our proprietary transdermal drug delivery to create ready-to-license, clinically proven highly effective, low-risk and cost-effective in development products.
The company's Not-for-Profit subsidiary, The Langford Research Institute, is a licensed pharmaceutical manufacturer in Florida, FDA-licensed Drug Labeler, NIH-registered research site and IRB and licensed by U.S. DEA as a researcher and exporter.
Approval is advancing through clinical stages with FDA for HypoSpray® drug combinations with Testosterone and Epinephrine. HypoSpray Pharma recently produced successful initial clinical trials for HypoSpray® delivery of Insulin.
HypoSpray Pharma has conducted successful clinical trials at Barts & the London NHS, one of Europe’s oldest and most clinically pre-eminent teaching and research hospitals, under approvals of National Health Service (NHS) Ethics and the MHRA. HypoSpray Pharma’s immediate clinical testing program is focused on numerous HypoSpray® drug combinations.
HypoSpray® has received patents for its technologies and has clear opportunities to extend this intellectual property. Each drug combination with the HypoSpray® represents new intellectual property.
HypoSpray® technology in application can generate new products from up to 70% of the drugs in the marketplace today. The approach is to enhance new discoveries with safer, low-dose delivery that are user-friendly and re-purpose products that are off patent and address large markets. Initially in four key markets—Hormone Replacement Therapy (testosterone), Adrenaline insufficiency and Anaphylaxis(Epinephrine), Pain Management (Diclofenac Sodium , and Diabetes (Human Insulin). HypoSpray® current product pipeline addresses markets with aggregate size of approximately $100 billion.
HypoSpray Pharma has met with the FDA and agreed on a plan for data development supportive of an approvable NDA under section 505(b)2 of the FDACA.
HypoSpray® leverages the 505(b)2 filing on already established efficacy and safety of the referenced active ingredient, so review times with FDA are more similar to ANDA’s for generic drugs because efficacy and safety are not in question, only the bio-equivalence and skin safety of the skin-delivered HypoSpray® product