Development of Medications to Prevent and Treat Opioid and/or Stimulant Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional)

This text refers to a funding opportunity aimed at supporting the creation and development of medications to help prevent and treat opioid and/or stimulant use disorders, also known as OUDs, and possible overdoses. The opportunity is in the form of the UG3/UH3 Phase Innovation Awards Cooperative Agreement, which consists of two phases.

The first stage, labeled UG3, provides financial support for a project targeting specified milestones to be achieved over a two-year period. The second phase, known as UH3, provides funding for three years for a project that has successfully met the UG3 phase's milestones.

Applications for the grant should address both phases. The scope of the research can be either preclinical or clinical and should make a significant impact and quickly provide the needed results to advance the proposed medications closer to FDA approval.

The proposed medications, which can be small molecules or biologics, should exhibit safety and effectiveness in preventing and treating OUDs and possible overdoses. They can be tested in pre-clinical models and/or for clinical manifestations of OUDs, such as withdrawal symptoms, craving, relapse, or overdose. Other potential topics for applications could include the development of new chemical entities, new formulations of existing medications marketed for other medical conditions, or combinations of medications with potential for treating OUDs and overdoses.

Overall, the National Institute on Drug Abuse (NIDA) aims to expedite the discovery and development of medications that can prevent and treat OUDs or opioid overdoses and speed up their progress in the FDA's drug development and approval process through this funding opportunity announcement.