The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the development of regulated therapeutic and diagnostic solutions for patients affected by opioid and/or stimulant use disorders (OUD/StUD). The current drug crisis surrounding these disorders has resulted in a significant number of deaths and an urgent need for comprehensive solutions. The solicitation is focused on the research and development of medical products regulated by the U.S. Food and Drug Administration (FDA), including pharmacotherapeutics and medical therapeutic and diagnostic devices.
In the area of pharmacotherapeutics, the solicitation encourages the development of small or large molecule agents, biologics, natural products, longer-acting formulations of existing addiction medications, advanced drug delivery systems, and the development and characterization of biomarkers. Proposed activities may include target identification, assay development, lead optimization, preclinical studies, formulation development, and process development. The ultimate goal is to file an Investigational New Drug (IND) application and conduct clinical studies to support the filing of a New Drug Application (NDA) or a Biological License Application (BLA).
In the area of medical therapeutic and diagnostic devices, the solicitation seeks research and development of imaging technologies, devices for diagnosing and reducing craving and withdrawal symptoms, therapeutic devices, devices for treating pediatric patients, in vitro diagnostic assays, digital therapeutics, devices for detecting and treating opioid-induced respiratory depression, and data science and cloud-based technologies. Proposed activities may include studies supporting an Investigational Device Exemption application, process development, non-clinical safety studies, clinical trials, and engagement with the FDA Center of Devices and Radiological Health. The goal is to successfully file an FDA premarket application for clearance/approval.
The solicitation is open for applications and offers funding for Phase I, Phase II, and Fast Track projects. Phase I aims to establish the technical merit and feasibility of the proposed research, while Phase II continues the R&D efforts to advance the technology toward commercialization. Fast Track applications combine Phase I and Phase II into one application to reduce or eliminate the funding gap between phases. Small businesses that have received Phase I STTR awards are eligible to submit Phase II applications as "Renewal" applications.