The U.S. National Institute on Drug Abuse (NIDA) awarded a $19,302,777 Cooperative Agreement under the Drug Use and Addiction Research Programs (CFDA 93.279) to Nirsum Laboratories, Inc. to advance the development of their NRS-033 drug candidate for opioid use disorder (OUD) treatment. The funding will support late-stage chemistry, manufacturing, and controls (CMC) work, non-clinical studies, and quality systems to accelerate NRS-033 towards pivotal trials and FDA registration. This project aims...
The federal Cooperative Agreement award UG3DA059278, funded by the National Institute on Drug Abuse (NIDA) under the Drug Use and Addiction Research Programs (CFDA 93.279), aims to develop SBS-226, a novel mu-opioid receptor (MOR) agonist and delta-opioid receptor (DOR) antagonist, for the treatment of opioid use disorder (OUD). The $11,872,077 project will support comprehensive IND-enabling development and a Phase 1 clinical trial for SBS-226, a non-addictive compound demonstrated to have...
This $562,014 Project Grant awarded by the National Institute on Drug Abuse (NIDA) under the Drug Use and Addiction Research Programs (CFDA 93.279) supports research to investigate the role of the medial habenula and interpeduncular nucleus circuit in opioid dependence and withdrawal. The 5-year project, running from September 2024 to July 2029, will use molecular, physiological, and behavioral approaches to determine how mu-opioid receptor signaling in this circuit influences its function and...
The National Institute on Drug Abuse (NIDA) awarded Duke University a $1,485,691 Project Grant under the Drug Use and Addiction Research Programs (CFDA 93.279) to conduct research on the neural correlates and behavioral impact of withdrawal-induced hyperalgesia among people who smoke with and without chronic pain. The project aims to: 1) evaluate the impact of smoking withdrawal on brain functional magnetic resonance imaging (fMRI) response to noxious heat stimuli in smokers with and without...
This cooperative agreement award from the National Institute on Drug Abuse (NIDA), under the Drug Use and Addiction Research Programs (CFDA 93.279), provides $14,583,710 to Uswm LLC to complete the FDA registration and development program for expanding the use of lofexidine (marketed as Lucemyra) to treat opioid withdrawal in adolescents. The key components of the program include: 1) Conducting a Phase 1 pharmacokinetic study in adolescents to establish dosing through exposure matching and...
This Cooperative Agreement award from the National Institute on Drug Abuse (NIDA), under the Drug Use and Addiction Research Programs (CFDA 93.279), aims to develop and commercialize a new technology-enabled approach for more personalized methadone dosing for the treatment of opioid use disorder (OUD). The $2,402,305 award, spanning July 2024 to June 2027, will fund the development and validation of a point-of-care device that can quickly assess an individual patient's methadone metabolism...
This Project Grant award from the National Institute on Drug Abuse (NIDA), under the Drug Use and Addiction Research Programs (CFDA 93.279), provides $340,000 in funding for research to better understand the role of the locus coeruleus-noradrenergic (LC-NE) system in fentanyl withdrawal and associated negative affective behaviors. The research aims to determine whether withdrawal from fentanyl selectively modifies the excitatory input from the ventral tegmental area (VTA) to the LC-NE system,...
This Project Grant award from the National Institute on Drug Abuse (NIDA), under the Drug Use and Addiction Research Programs (CFDA 93.279), is focused on conducting preclinical trials to investigate the use of Neuropeptide S (NPS) receptor-targeted molecules as a potential treatment for opioid use disorders. The $419,876 award, spanning the period from September 2024 to August 2026, will support proof-of-concept studies to determine if NPS receptor-targeted molecules can reduce oxycodone taking...
This Cooperative Agreement, awarded by the National Institute on Drug Abuse (NIDA) under the Drug Use and Addiction Research Programs (CFDA 93.279), provides $23,579,701 in funding to Ensysce Biosciences, Inc. from September 1, 2024 to May 31, 2027 to continue the clinical development of PF614-MPAR. PF614-MPAR is a novel opioid product that combines a trypsin-activated abuse protection (TAAP) technology with a trypsin inhibitor to provide overdose protection. The goals of this project are to...
The National Institute on Drug Abuse (NIDA) awarded a $2,902,673 Project Grant under the Drug Use and Addiction Research Programs (CFDA 93.279) to Rutgers, The State University of New Jersey, with a sub-award to The Washington University. The grant aims to establish OPRM1 exon 7-associated variants as novel therapeutic targets for mitigating adverse effects of clinically used mu opioids, such as fentanyl and oxycodone, without altering their analgesic properties for pain management. The research...