SBIR Phase II: Novel, injectable, long-acting, local anesthetic for postoperative pain management

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The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is a novel therapeutic for surgical pain that can eliminate the need for opioids after surgery. This project will yield a novel, long-acting local anesthetic drug product that can provide substantial value to customers as an affordable, safe, and effective, non-opioid, acute pain management solution. The technology can provide significant value to hospital systems, physicians, and patients alike by reducing healthcare costs associated with opioid-related adverse events and preventing opioid addiction by eliminating their use after surgery. In 2021, there was a historic rise in opioid overdose deaths to over 80,000 individuals. Opioid use disorder-related Medicaid spending has more than tripled in the last 15 years and the opioid crisis has been estimated to cost $72.4 billion during that time period. Preventing opioid addiction by reducing exposure of opioids to surgical patients can have a significant impact on reducing financial costs to society as a whole. In 2017, there were an estimated 48 million major surgical procedures requiring postoperative pain management in the United States, representing a $17 billion total addressable US market.This Small Business Innovation Research (SBIR) Phase II project seeks to perform Food and Drug Administration (FDA) required manufacturing characterization and animal studies to demonstrate the novel, injectable, long-acting local anesthetic technology is safe for initial human use. The solution involves a novel oleogel-based injectable drug delivery system that can provide local sustained delivery of lipophilic small molecule drugs. In Phase I, the team optimized the technology for rheological properties, drug release kinetics, and stability to create an injectable gel that provides 96 hours of sustained bupivacaine delivery.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.