The National Institute on Drug Abuse (NIDA) awarded a $1,539,426 Project Grant (CFDA 93.279 - Drug Use and Addiction Research Programs) to Serodopa Therapeutics Inc. to develop a novel intranasal formulation of a naloxone derivative for the reversal of opioid-induced respiratory depression caused by high-potency opioids such as fentanyl. The project aims to complete formulation development, preclinical toxicology and safety testing required to prepare an Investigational New Drug (IND)...
This Cooperative Agreement award from the National Institute on Drug Abuse (NIDA), under the Drug Use and Addiction Research Programs (CFDA 93.279), provides $3,138,031.00 to Sparian Biosciences Inc. (doing business as Palion Therapeutics) to conduct clinical development of SBS-147, a first-in-class non-opioid oral arylepoxamide agonist for the treatment of acute and chronic pain. The award will fund a Phase 1 SAD/MAD clinical trial to characterize the safety, tolerability, and...
The National Institute on Drug Abuse (NIDA) awarded a $11,811,988 Cooperative Agreement (CFDA 93.279 - Drug Use and Addiction Research Programs) to The University of Texas Health Science Center at San Antonio (UTHSCSA) on August 15, 2024. The 3-year project aims to continue developing the novel mu-opioid receptor antagonist Methocinnamox (MCAM) for preventing opioid relapse after detoxification. Key objectives include submitting an Investigational New Drug (IND) application, completing Phase 1...
This Cooperative Agreement award, valued at $11,872,077.00, was granted by the National Institute on Drug Abuse (NIDA) under the federal Drug Use and Addiction Research Programs (CFDA 93.279). The funding supports the development of SBS-226, a novel non-addictive chemical entity that acts as a mu-opioid receptor (MOR) agonist and delta-opioid receptor (DOR) antagonist, for the treatment of opioid use disorder (OUD). The primary recipient, Sparian Biosciences Inc. (doing business as Palion...
This Cooperative Agreement award, totaling $2,104,389.00, was provided by the National Institute on Drug Abuse (NIDA) under the federal Drug Use and Addiction Research Programs (CFDA 93.279). The award supports research to evaluate the use of oxytocin, an FDA-approved drug, to treat opioid-induced respiratory depression and prevent opioid overdose lethality. Specifically, the research will: 1) identify the optimal dose, route of administration, and redosing requirements for oxytocin to reverse...
The National Institute on Drug Abuse (NIDA) awarded a $220,668 Project Grant under the Drug Use and Addiction Research Programs (CFDA 93.279) to Amalgent Therapeutics, Inc. in Greenville, NC. This grant supports the development of a novel opioid adjuvant technology that aims to enhance the pain-relieving efficacy of opioid medications while mitigating risks such as abuse potential, tolerance, and neuropathic pain. The project has two key objectives: 1) investigating the mechanism by which the...
This federal Cooperative Agreement award from the National Institute on Drug Abuse (NIDA), under the Drug Use and Addiction Research Programs (CFDA 93.279), provides $4,710,576.00 to Mebias Discovery Inc. to develop a new chemical entity, MEB-1170, as a maintenance medication for the treatment of opioid use disorder (OUD). The project aims to complete preclinical studies in rodents and non-human primates to evaluate the efficacy of MEB-1170 in reducing fentanyl self-administration and its safety...
The National Institute on Drug Abuse (NIDA), under the federal Drug Use and Addiction Research Programs (CFDA 93.279), awarded Labsys LLC a $643,948 Project Grant to develop a wearable continuous drug monitoring device for opioid use disorders (CDM-MOUD). The goal is to create a low-cost, pain-free patch that can monitor medication levels in the interstitial fluid and provide real-time insights into the effectiveness of opioid use disorder treatment protocols. In Phase I, Labsys will engineer an...
This federal Project Grant award from the National Institute on Drug Abuse (NIDA), under the Drug Use and Addiction Research Programs (CFDA 93.279), provides $419,876 to conduct preclinical trials targeting the neuropeptide S (NPS) receptor to mitigate opioid taking and seeking behaviors in animal models. The goals of the project are to demonstrate proof-of-concept that NPS receptor-targeted molecules can reduce oxycodone self-administration and motivation in rats, which could inform the...
This federal Project Grant award from the National Institute on Drug Abuse (NIDA), under the Drug Use and Addiction Research Programs (CFDA 93.279), is funding the development of a novel epigenetic regulator as a potential treatment for opioid use disorder (OUD). The grantee, Epivario Inc., a for-profit biotechnology research organization, will screen a new class of ACSS2 inhibitors and evaluate their efficacy in preclinical animal models of OUD. Specifically, the $275,253 award will support...
The National Institute on Drug Abuse (NIDA), under the federal Drug Use and Addiction Research Programs (CFDA 93.279), has awarded a $23,579,701 Cooperative Agreement to Ensysce Biosciences, Inc. to support the clinical development of PF614-MPAR, an opioid product with oral overdose protection.
The key objectives of this project are to continue the clinical development of PF614-MPAR, a combination product of a trypsin-activated abuse protection (TAAP) oxycodone prodrug and a trypsin inhibitor (nafamostat), to ensure all dosage strengths (25 mg, 50 mg, and 100 mg) can provide pain relief at the prescribed dose while offering overdose protection at greater than prescribed dose levels. The project will conduct a multi-ascending dose study to evaluate the safety and oxycodone release profiles of the PF614-MPAR combination product across the different dosage strengths. These clinical studies will be carried out in parallel with supporting non-clinical studies to enable a future new drug application.