This SBIR Phase II award from the National Institute on Drug Abuse (NIDA), under the Drug Use and Addiction Research Programs (CFDA 93.279), is supporting the development of a novel intranasal formulation of a naloxone derivative by Serodopa Therapeutics, Inc. This $1,539,426 project aims to complete the formulation development and preclinical testing required to bring this new opioid overdose reversal agent to the point of IND submission and Phase 1 clinical trials. The key goals include selecting a lead formulation, establishing the preclinical toxicology and safety profiles, and preparing for an IND filing with the FDA. This work builds on preliminary proof-of-concept studies demonstrating the therapeutic potential of this novel naloxone derivative to more effectively reverse respiratory depression caused by high-potency synthetic opioids like fentanyl, compared to standard naloxone treatment.
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