According to Virpax Pharmaceuticals, the FDA has provided guidance in response to the company’s pre-Investigational New Drug NobrXiol (VRP324) CBD nasal powder, which Virpax is developing for the for the treatment of epilepsy. In September 2021, Virpax announced that it had acquired exclusive worldwide rights to Nanomerics’s molecular envelope technology (MET) for use with VRP324, and the company reported results from a pre-clinical study of VRP324 in a rodent model in April 2022.
Virpax Chief Scientific Officer Sheila A. Mathias commented, “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.”
Chairman and CEO Anthony P. Mack said, “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. 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.”
Read the Virpax Pharmaceuticals press release.
