This Cooperative Agreement award from the National Institute on Drug Abuse (NIDA), under CFDA Program 93.279 - Drug Use and Addiction Research Programs, is supporting the development of a bioabsorbable, subcutaneous, extended-release buprenorphine implant for the treatment of opioid use disorder (OUD). The $2,932,500 award to The Drug Delivery Company, LLC will fund the development of this 6-month buprenorphine implant, building upon the company's prior success with a 6-month bioabsorbable...
This Project Grant award from the National Institute on Drug Abuse (CFDA 93.279 - Drug Use and Addiction Research Programs) provides $541,080 to The Trustees of Columbia University in the City of New York to conduct a randomized controlled trial examining the use of extended-release injectable buprenorphine versus sublingual buprenorphine/naloxone in treating opioid use disorder (OUD) among individuals who use high-potency synthetic opioids. The key objectives are to compare abstinence and...
This $385,000 Project Grant award from the National Institute on Drug Abuse (NIDA) under the Drug Use and Addiction Research Programs (CFDA 93.279) aims to advance integrated treatment for co-occurring opioid use disorder (OUD) and alcohol use disorder (AUD) in real-world settings. The key objectives are to: Assess the effectiveness of integrated treatment approaches, including first-line medications and glucagon-like peptide-1 receptor agonists (GLP-1 RAs), for patients with co-occurring OUD...
The National Institute on Drug Abuse (NIDA), under the Drug Use and Addiction Research Programs (CFDA 93.279), awarded a $267,000 Project Grant (R21DA058120) to The Children's Hospital Corporation (Boston Children's Hospital) to develop depot formulations for on-demand, tamper- and diversion-proof delivery of opioids. The goal is to create injectable polymer-based depot formulations that are covalently bonded to opioids via photolabile linkers, which would make the formulations resistant to...
The National Institute on Drug Abuse (NIDA) awarded Rebel Medicine Inc. a $591,842 Project Grant under the Drug Use and Addiction Research Programs (CFDA 93.279) to develop an extended-duration injectable local anesthetic formulation as an alternative to opioid-based pain medications. The project aims to demonstrate the safety and efficacy of a proprietary lipophilic bupivacaine oleogel formulation that can provide up to 7 days of sustained pain relief from a single injection, mitigating the...
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...
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 Project Grant award of $1,476,750.00, provided by the National Institute on Drug Abuse (NIDA) under the Drug Use and Addiction Research Programs (CFDA 93.279), supports a pilot randomized controlled trial to evaluate the use of the medication semaglutide as an adjunct to buprenorphine for the treatment of opioid use disorder (OUD). The study aims to assess semaglutide's impact on reducing cue-induced craving and its safety and tolerability over a 12-week period in individuals with OUD who...
This Project Grant award from the National Institute on Drug Abuse (NIDA), under the Drug Use and Addiction Research Programs (CFDA 93.279), provides $598,312 to Addinex Technologies, Inc. to integrate and assess the practicality of a closed-loop medication management system for opioid pain management targeting ambulatory patients with extremity fractures being discharged from the emergency department. The key objectives are to adapt the Addinex system to seamlessly integrate with hospital...
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)...
A LONG-ACTING BIOABSORBABLE NALTREXONE SUBCUTANEOUS IMPLANT FOR OPIOID USE DISORDER - PROJECT SUMMARY/ABSTRACT THE OBJECTIVES FOR THIS PROPOSAL ARE (1) DETERMINING THE OPTIMAL CHEMICAL PREPARATION TO INJECT INTO THE IMPLANT FOR DELIVERY OF NALTREXONE (NTX) TO MINIMIZE TOXICITY WHILE MAXIMIZING EFFICACY, (2) DETERMINE THE OPTIMAL COMPOSITION AND POROSITY OF THE DRUG DELIVERY IMPLANT TO ACHIEVE THE THERAPEUTIC SERUM LEVELS OF NTX AS WELL AS (3) REFINEMENT OF THE SURGICAL PROCEDURE AND INSTRUMENTATION TO FACILITATE THE SAFE AND EFFECTIVE DEPLOYMENT OF THE IMPLANT. TO ADDRESS THESE ISSUES, THE STUDY TEAM WILL EXECUTE THE FOLLOWING SPECIFIC AIMS: AIM 1: VALIDATE TWO FORMULATIONS OF NTX, LIPOSOMAL ENCAPSULATION AND PLGA ENCAPSULATION, FOR SUSTAINED RELEASE FROM THE IMPLANT WITH PROOF OF IN VITRO STABILITY AND PHARMACOKINETICS UNDER GLP/GCP. AIM 2: ASSESS SURGICAL PROCEDURE AND SPECIALIZED INSTRUMENTS FOR REPLICABLE AND SAFE IMPLANTATION. AIM 3: OPTIMIZE THE NTX DRUG FORMULATION AND IMPLANT DESIGN IN VIVO. AIM 4: COMPLETE A SIX TO TWELVE-MONTH STUDY TO VERIFY THE SAFETY AND EFFICACY OF THE NTX IMPLANT NEEDED FOR AN INVESTIGATIONAL NEW DRUG/INVESTIGATIONAL DEVICE EXEMPTION APPLICATION AND CLINICAL TRIALS. AS THE OPIOID CRISIS LINGERS, THE PROPOSED STUDY HAS DIRECT APPLICATION TO THE HEALTH CONCERNS OF THE NATION AND TO THE NIH AS THE STUDY TEAM SEEKS A FUNDAMENTAL SOLUTION AND ANSWER TO ENHANCE HEALTH, LENGTHEN LIFE, AND REDUCE ILLNESS AND DISABILITY FOR THOSE SUFFERING FROM AN OPIOID USE DISORDER (OUD). THE PHASES OF THE PROJECT WILL INCLUDE: ENGINEERING, SURGICAL TECHNIQUE REFINEMENT, PHARMACEUTICAL FORMULATION, BIOANALYTICAL EVALUATION - BOTH: IN VIVO AND IN VITRO, SURGICAL IMPLANTATION IN 2 SPECIES, COLLECTION OF THE PHARMACOKINETIC BIO-ANALYTICAL DATA, TOXICOLOGY/NECROPSY STUDIES AND ANALYSIS OF THE DATA. SPECIFIC TESTS AND COMPARISONS WILL INCLUDE NTX FORMULATION (DISSOLUTION GROUPS AND 1-MONTH IN VIVO (RODENT)), BALLOON MATERIAL IN VIVO, (RODENT), THERAPEUTIC (6 TO 12 MONTH IN VIVO RODENT AND CANINE), AND CONTROL (6 TO 12 MONTH IN VIVO RODENT AND CANINE) AND OPIOID/FENTANYL CHALLENGE IN CANINES. UPON SUCCESSFUL CONCLUSION OF THE IN VIVO TRIALS WITH PROVEN EFFICACY AND SAFETY, FDA APPROVAL AND CLINICAL TRIALS WILL BEGIN. IN THE PHASE I STUDY, WE PLAN ON TESTING 3 DIFFERENT DOSES OF NI ALONG WITH A PLACEBO LOADED IMPLANT IN HEALTHY VOLUNTEERS. THE PHASE 2 CLINICAL TRIAL OF THE NI WILL BE PERFORMED IN SUBJECTS WITH OUD TO DETERMINE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF THE NI. WE WILL ASSESS TWO DOSES OF NI AND COMPARE THIS TO THE EFFICACY OF A COMMERCIALLY AVAILABLE ONE MONTH EXTENDED RELEASE NALTREXONE (XR-NTX) (VIVITROL, ALKERMES) GIVEN MONTHLY FOR SIX MONTHS.