Virpax® Pharmaceuticals, Inc. a company specializing in developing non-addictive products for pain management, post-traumatic stress disorder, central nervous system disorders and viral barrier indications, today announced that it has received pre-Investigational New Drug application guidance from the U.S. Food and Drug Administration for NobrXiol™, the Company’s product candidate for the delivery of cannabidiol in the management of epilepsy in children and adults. NobrXiol utilizes the Nanomerics Molecular Envelope Technology as its delivery system to cross the blood brain barrier, propelling the cannabidiol nanoparticles through the nose to the brain via the olfactory nerve.
The main purpose of a pre-IND submission is to obtain FDA guidance on the overall development plan for a new drug and to identify any need for further data prior to submitting the IND.
“Virpax now has guidance on how to proceed with the IND enabling studies and possible regulatory pathways to pursue for NobrXiol. Based on the written responses from the FDA and its recommendations, we believe that we can proceed with the next steps in the process towards an IND application for this product candidate.”
Dr. Sheila A. Mathias, Chief Scientific Officer for Virpax
“This is a significant step forward for the NobrXiol project and we are very pleased with the outcome of the pre-IND meeting with the FDA,” said Anthony P. Mack, Chairman and CEO of Virpax. “We believe this product candidate has potential benefits over existing oral CBD treatments for epilepsy including Dravet Syndrome and Lennox-Gastaut Syndrome. We believe that by using the MET delivery system there may be significant advantages for patients including fewer side effects, avoidance of drug-to-drug interaction and lower dosing of CBD required,” concluded Mr. Mack.
Virpax has acquired the exclusive worldwide rights from Nanomerics to use Nanomerics' MET platform for the nasal delivery of cannabidiol or the management of epilepsy in children and adults. As part of this agreement, Nanomerics is developing an investigational formulation delivered via the nasal route to enhance CBD transport to the brain which could potentially eliminate any drug interaction issues and bypass the digestive system, possibly eliminating many of the side effects associated with the product currently in use on the market. Nanomerics demonstrated the ability of its platform technology to deliver CBD directly to the brain in an animal model.
About Virpax Pharmaceuticals
Virpax is developing branded product candidates for non-addictive pain management and neurological disorders using its proprietary technologies that optimize and target drug delivery. Virpax is initially seeking FDA approval of its three different patented drug delivery platforms. Epoladerm™ is a topical diclofenac spray film formulation being developed to manage pain associated with osteoarthritis of the knee. Probudur™ is a single injection long-acting liposomal bupivacaine formulation being developed to manage post-operative pain. Envelta™ is an intranasal Molecular Envelope Technology enkephalin formulation being developed for the management of acute and chronic pain, including pain associated with cancer, as well as post-traumatic stress disorder under the name PES200. MET technology is also used in AnQlar™, a candidate to inhibit viral replication caused by influenza or SARS-CoV-2. Virpax acquired global rights to NobrXiol™, a product candidate for the nasal delivery of a pharmaceutical-grade cannabidiol for the management of epilepsy in children and adults.