Fast, Centrally Acting, Non-Addicting Novel Analgesic for Chronic Non-Cancer Pain

National Center For Advancing Translational Sciences

Investigators

Linked publications, trials & patents

Abstract

Virpax Pharmaceuticals has developed NES100, a formulation of leucine-enkephalin (L-ENK) in a novel Molecular Envelope Technology (MET) that enables the efficient intranasal delivery of L-ENK directly to the brain with minimal peripheral exposure. To date, the TDB team has completed confirmatory studies to evaluate NES100 in an in vivo acute pain model, using a sensitive bioanalytical method developed to detect L-ENK in plasma and brain. GLP in vitro genetic toxicity studies and GLP in vivo toxicology and safety assessments have been completed. The manufacturing of non-GMP and GMP MET (drug substance) has been completed. Formulation development and manufacture of the complete drug-device combination product will begin shortly. This will involve production of the non-GMP pilot batch, followed by manufacturing and packaging of the full GMP product. Completion of these activities will support the filing of an Investigational New Drug application to the Food and Drug Administration.