Currently, there are medications approved by the Food and Drug Administration (FDA) for the treatment of nicotine and opiate dependence. However, none of these medications provides optimal therapy. There are no FDA approved medications for cocaine, methamphetamine, or cannabis use disorders. Thus, the development of safe and effective medications to treat these disorders is an urgent public health need.
Scientific advances are offering extraordinary opportunities for the development of medications to treat SUDs. These advances include the discovery of genes and proteins, receptors, neurotransmitters, neuromodulators, and brain circuits associated with drug abuse, as well as risk and protective factors for the onset and progression of these disorders. Multiple therapeutic approaches may be poised for the next step in the FDA approval process and concerted efforts are needed to advance them closer to approval.
The purpose of this Award is to support outstanding basic and/or clinical researchers with the vision and expertise to translate research discoveries into medications for the treatment of Substance Use Disorders (SUDs) stemming from tobacco, cannabis, cocaine, methamphetamine, heroin, or prescription opiate use. Eligible applicants must demonstrate the ability to develop molecules with the potential to treat SUDs and advance them in the drug development continuum. The ultimate goal of this FOA is to bring molecules closer to FDA approval.
The UG3/UH3 Phased Innovation Awards Cooperative Agreement involves 2 phases. The UG3 will support a project with specific milestones to be accomplished at the end of the 2-year period. The UH3 will provide funding for 3 years to a project that successfully completed the milestones set in the UG3. UG3 projects that have met their milestones will be administratively considered by NIDA and prioritized for transition to the UH3 phase. Investigators responding to this FOA must address both UG3 and UH3 phases.
Applicants for this NIDA Translational Avant-Garde Award are expected to have a robust body of background data in the basic science and early discovery phases to be poised for transition of a lead compound to the preclinical and clinical phases of medications development. NIDA seeks to promote research projects that are ready for translation and can accelerate the development of new medications. Projects responsive to this announcement could be undertaken at any point along the drug development continuum, from late discovery (i.e., lead optimization/early safety) up to clinical trials. For small molecules, the earliest stage of eligibility for this Award is already having small-molecule compounds with proof of desired pharmacological activity. For biologics, the profiling of promising product candidates in animal models of drug addiction will be allowed as the earliest entry point.
Applications focusing solely on novel target identification/validation, generation of new animal models, development/testing of new human laboratory models, assay development, new biomarkers, or mechanistic studies of the neurobiology of addiction are considered non-responsive for the NIDA Translational Avant-Garde Award.
Applications submitted in response to this FOA may focus on studying 1) new chemical entities (NCEs), 2) already-marketed pharmacotherapies, 3) biologics (e.g., immunotherapies such as vaccines and antibodies, enzymes, and gene therapies), 4) combinations of medications, and/or 5) new delivery devices/technologies.
The medications investigated for SUDs may target one or more of the neuropathological mechanisms, the various clinical stages, and/or the medical/psychiatric complications of one or multiple SUDs.
This FOA encourages, but is not limited to, studies of medications for SUDs in the following areas:
Chemistry and Pharmaceutics: lead compound optimization, formulation or drug-delivery technology, prodrug, biologics (e.g., vaccines and antibodies).
Preclinical Development: drug interaction studies between medications and drugs of abuse, evaluation of compound safety and/or efficacy in established animal models, pharmacokinetic and pharmacodynamic studies of potential therapies for SUDs, as well as IND enabling studies.
Clinical Development: Phase I – Evaluation of the pharmacokinetics, safety, tolerability, dose-ranging, and/or initial efficacy in human subjects. Phase II – Proof-of-concept, pilot studies, safety and efficacy testing in a larger sample of human subjects.
It is expected that all applications involving treatment seeking individuals will provide a behavioral therapy component. However, the scope of this FOA does not include the evaluation of the safety and/or efficacy of psychosocial interventions.
Awardees of this FOA may collaborate with pharmaceutical companies, academic investigators, and/or intramural NIH scientists. Awardees are encouraged to make their datasets and aggregated datasets available for data sharing to other investigators when appropriate.
All studies involving NIH defined clinical trials must have a Data and Safety Monitoring Plan (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html). The DSMB is responsible for reviewing interim and final data, and recommending whether the study be continued, modified, or terminated. The DSMB reviews the protocols, monitors recruitment, adverse events, data quality, outcome data, and overall study performance. For those clinical trials that are required by this policy to have a Data and Safety Monitoring Board (DSMB), the investigators have the option of having their study monitored by the DSMB of the Division of Therapeutics and Medical Consequences of Drug Abuse (DTMC) of NIDA. This DSMB reports to the Director, DTMC. The awardees also have the option to use another DSMB. Applications involving one or more clinical trials must state that the clinical trial(s) will be monitored by a DSMB, which could be the DTMC sponsored DSMB. The DSMB to be used for each trial will be agreed upon with NIH prior to the award.
Deadlines: July 25, 2018; July 25, 2019, July 25, 2020 (full proposals; letters of intent due 30 days prior to the deadline)
Filed Under: Funding Opportunities