Notice Number: NOT-NS-18-019

Key Dates
Release Date: November 27, 2017

PAR-19-039 - Countermeasures Against Chemical Threats (CounterACT): Identification of Therapeutic Lead Compounds (U01 Clinical Trial Not Allowed)

PAR-19-040 -Countermeasures Against Chemical Threats (CounterACT): Optimization of Therapeutic Lead Compounds (U01 Clinical Trial Optional)

PAR-20-253 - Countermeasures Against Chemical Threats (CounterACT) Exploratory/Developmental Projects (R21 Clinical Trial Not Allowed)

PAR-20-316 - NIH Countermeasures Against Chemical Threats (CounterACT) Research Centers of Excellence (U54 - Clinical Trial Optional)

Issued by
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute on Drug Abuse (NIDA)

Purpose

The purpose of this notice is to highlight the NIH/NINDS Countermeasures Against Chemical Threats (CounterACT) program's interest in developing safe and effective therapeutics that would prevent morbidity and mortality following exposure to the opioids fentanyl, carfentanil, acetylfentanyl, alfentanil, and/or diacetylmorphine (heroin). The program concentrates on developing therapeutics to treat and/or prevent injuries and deaths that may result from exposure to chemical threats in a variety of scenarios. Applications are being accepted under three specific Funding Opportuntiy Announcements (FOAs) issued by the NIH CounterACT program (PAR-15-315, PAR-16-330, and PAR-16-331). To be considered appropriate to these FOAs, applications must follow the instructions and general descriptions found in these FOAs as well as the following requirements related to the specialized mission of the NIH CounterACT program.

Research supported by these FOAs must be relevant to chemical emergencies where the general civilian population might be exposed to opioids. The research might include industrial accidents, natural disasters causing casualties, or deliberate attacks again civilians. Some examples of research that could be supported include, but are not limited to, the following:

• Safety and efficacy studies of naloxone and other FDA-approved drugs for use against the opioids listed above, especially as they relate to potential respiratory problems
• Safety and efficacy studies of naloxone and other FDA-approved drugs for use against the opioids listed above when these opioids are administered by a method consistent with a deliberate attack against civilians, or by industrial accidents or natural disasters causing mass casualties (e.g. aerosolized, in food or water, etc.)
• Other opioid overdose antidotes with greater safety and efficacy than naloxone and other FDA- approved drugs to match the higher potency of fentanyl analogues, including naloxone-related antidotes and those based on new therapeutic targets
• Antidotes with longer half-lives so that multiple doses are not needed in rapid succession, and many people can be treated at once during a mass casualty event; this includes increases in serum half-life as well as alteration of degradative metabolism
• Single antidotes with acceptable activity against at least two or more of the opioids listed above

The NIH CounterACT program will support exploratory and developmental research (PAR-15-315) as well as the identification (PAR-16-330) and optimization (PAR-16-331) of therapeutic lead compounds. Potential applicants should see the descriptions of scientific scope found in these FOAs.

Applicants are strongly urged to contact NIH representatives listed below prior to submission.

Inquiries

Please direct all general NIH CounterACT inquiries to:

David A. Jett, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-6035
Email: [email protected]

Please direct specific opioid research inquiries:

Kiran Vemuri, Ph.D.
National Institute on Drug Abuse (NIDA) Telephone:301-402-3396
Email: [email protected]