Developing Regulated Therapeutic and Diagnostic Solutions for Patients Affected by Opioid and/or Stimulants use Disorders (OUD/StUD) (R43/R44 - Clinical Trial Optional)

The NIH’s funding opportunity RFA-DA-23-021, titled "Developing Regulated Therapeutic and Diagnostic Solutions for Patients Affected by Opioid and/or Stimulants use Disorders (OUD/StUD)," invites SBIR applications from U.S.-based small businesses aiming to develop FDA-regulated treatments and diagnostics for opioid and stimulant use disorders. This opportunity allows for clinical trials but does not require them. Projects can focus on pharmacotherapeutics (small molecules or biologics) or medical devices, including diagnostic tools and software as a medical device, aimed at addressing the addiction crisis. The program does not specify total funding or award limits, nor does it require cost-sharing. Eligible applicants include only U.S. small businesses; foreign entities and non-U.S. components of U.S. organizations are not eligible, though foreign components may be permissible as defined in NIH policy. Proposals must emphasize commercial viability and regulatory compliance for products intended to meet urgent treatment and diagnostic needs for OUD and StUD. Applications are due by February 14, 2025, with further details accessible on the NIH grants website. For additional questions, applicants can contact the NIH OER Webmaster at OERWebmaster03@od.nih.gov.