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Cooperative Agreement UG3DA048745
Award Date
9/30/19
Completion Date
8/31/22
Dollars Obligated
$6.4M
Overview
Activity
Transactions
3
Subawards
3
Federal Agency
National Institute on Drug Abuse
Awardee
Emergent Product Development Gaithersburg Inc. (CNPVCR8DK7M8)
Federal Grant Program
93.279
Assistance Type
Cooperative Agreement
Place of Performance
Maryland, USA
Description
Update #1
NALMEFENE LONG-ACTING INJECTABLE (AP007) FOR THE TREATMENT OF OPIOID USE DISORDER
Posted 9/25/19, 12:00 AM
Mod #
Description
Reason For Modification
Federal Obligation
(Click to sort descending)
Date
(Click to sort ascending)
Not listed
NALMEFENE LONG-ACTING INJECTABLE (AP007) FOR THE TREATMENT OF OPIOID USE DISORDER - PROJECT SUMMARY/ABSTRACT THE CURRENT OPIOID EPIDEMIC IS ONE OF THE MOST IMPORTANT PUBLIC HEALTH ISSUES IN THE UNITED STATES RESULTING IN INCREASED RELATED DISEASE, DISABILITY, AND DEATHS. AT LEAST TWO MILLION PEOPLE IN THE NATION HAVE AN OPIOID USE DISORDER (OUD). ALTHOUGH MEDICATIONS ARE AVAILABLE AS PART OF THE TREATMENT PARADIGM FOR OUD, ADHERENCE WITH TREATMENT PROGRAMS REMAINS A PROBLEM. EMERGENT IS DEVELOPING AN EXTENDED-RELEASE MICROPARTICLE FORMULATION OF NALMEFENE (AP007) FOR THE POTENTIAL TREATMENT OF OUD. NALMEFENE IS AN OPIOID RECEPTOR ANTAGONIST THAT WAS PREVIOUSLY APPROVED FOR TREATMENT OF OPIOID OVERDOSE-INDUCED RESPIRATORY DEPRESSION. IN CONTRAST TO OTHER OPIOID ANTAGONISTS, NALMEFENE HAS A LONGER DURATION OF ACTION. AP007 IS A UNIQUE FORMULATION COMPRISING OF NALMEFENE-LOADED POLY(LACTIC-CO-GLYCOLIC ACID) (PLGA) MICROPARTICLES. WHEN INJECTED INTRAMUSCULARLY, AP007 IS DESIGNED TO ACT AS A "DRUG DEPOT" WITH THE PURPOSE OF CONTINUALLY RELEASING AN EFFECTIVE DOSE OF NALMEFENE AND THUS REDUCE CRAVINGS FOR OPIOIDS IN PATIENTS WITH OUD. REDUCTION OF CRAVINGS CAN HELP PEOPLE WHO HAVE ALREADY STOPPED USING OPIOIDS REMAIN DRUG-FREE. EMERGENT IS CURRENTLY DEVELOPING AP007 AND WILL HAVE A LEAD FORMULATION SELECTED BASED ON IN VITRO RELEASE KINETICS DATA AND IN VIVO PHARMACOKINETICS DATA IN RATS BY THE START OF THE PROJECT. THE OBJECTIVES OF THE PROPOSED PROJECT ARE TO: (1) DETERMINE SAFETY AND EFFICACY OF AP007 IN A SWINE OPIOID USE/WITHDRAWAL MODEL, PRELIMINARY SAFETY IN A FIRST- IN-HUMAN PHASE 1 STUDY (UG3 PROJECT PHASE), AND PRELIMINARY EFFICACY IN A PHASE 2A MULTIDOSE STUDY; AND (2) FURTHER DEVELOP THE EFFICACY AND SAFETY DATA FOR AP007 IN HUMAN SUBJECTS IN PHASE 2 STUDIES, AND (3) INITIATE A PHASE 3 PIVOTAL EFFICACY CLINICAL STUDY (UH3 PROJECT PHASE). THE PROPOSED EFFICACY STUDIES WILL COMPARE EFFICACY OF AP007 WITH VIVITROL®, A MONTHLY INJECTION OF NALTREXONE CURRENTLY APPROVED FOR TREATMENT OF OUD. THROUGHOUT THE PROJECT, EMERGENT WILL LEVERAGE ITS EXPERIENCE DEVELOPING THERAPEUTICS TO MEET WITH THE FDA AND ALIGN THE DEVELOPMENT APPROACH WITH FDA GUIDANCE. DEPENDING ON THE RESULTS OF THIS PROJECT, EMERGENT INTENDS TO COMPLETE THE PHASE 3 STUDY AND SUBMIT THE RESULTS IN A NEW DRUG APPLICATION PACKAGE TO SUPPORT POTENTIAL LICENSURE OF AP007 AS A LONG-ACTING THERAPEUTIC TO HELP REDUCE OPIOID CRAVINGS BECAUSE OF ADDICTION. SUCH A TREATMENT IS INTENDED TO INCREASE ADHERENCE AND REDUCE RISK OF RELAPSE FOR PATIENTS WITH OUD. 1
$0
5/25/22
Not listed
NALMEFENE LONG-ACTING INJECTABLE (AP007) FOR THE TREATMENT OF OPIOID USE DISORDER - PROJECT SUMMARY/ABSTRACT THE CURRENT OPIOID EPIDEMIC IS ONE OF THE MOST IMPORTANT PUBLIC HEALTH ISSUES IN THE UNITED STATES RESULTING IN INCREASED RELATED DISEASE, DISABILITY, AND DEATHS. AT LEAST TWO MILLION PEOPLE IN THE NATION HAVE AN OPIOID USE DISORDER (OUD). ALTHOUGH MEDICATIONS ARE AVAILABLE AS PART OF THE TREATMENT PARADIGM FOR OUD, ADHERENCE WITH TREATMENT PROGRAMS REMAINS A PROBLEM. EMERGENT IS DEVELOPING AN EXTENDED-RELEASE MICROPARTICLE FORMULATION OF NALMEFENE (AP007) FOR THE POTENTIAL TREATMENT OF OUD. NALMEFENE IS AN OPIOID RECEPTOR ANTAGONIST THAT WAS PREVIOUSLY APPROVED FOR TREATMENT OF OPIOID OVERDOSE-INDUCED RESPIRATORY DEPRESSION. IN CONTRAST TO OTHER OPIOID ANTAGONISTS, NALMEFENE HAS A LONGER DURATION OF ACTION. AP007 IS A UNIQUE FORMULATION COMPRISING OF NALMEFENE-LOADED POLY(LACTIC-CO-GLYCOLIC ACID) (PLGA) MICROPARTICLES. WHEN INJECTED INTRAMUSCULARLY, AP007 IS DESIGNED TO ACT AS A "DRUG DEPOT" WITH THE PURPOSE OF CONTINUALLY RELEASING AN EFFECTIVE DOSE OF NALMEFENE AND THUS REDUCE CRAVINGS FOR OPIOIDS IN PATIENTS WITH OUD. REDUCTION OF CRAVINGS CAN HELP PEOPLE WHO HAVE ALREADY STOPPED USING OPIOIDS REMAIN DRUG-FREE. EMERGENT IS CURRENTLY DEVELOPING AP007 AND WILL HAVE A LEAD FORMULATION SELECTED BASED ON IN VITRO RELEASE KINETICS DATA AND IN VIVO PHARMACOKINETICS DATA IN RATS BY THE START OF THE PROJECT. THE OBJECTIVES OF THE PROPOSED PROJECT ARE TO: (1) DETERMINE SAFETY AND EFFICACY OF AP007 IN A SWINE OPIOID USE/WITHDRAWAL MODEL, PRELIMINARY SAFETY IN A FIRST- IN-HUMAN PHASE 1 STUDY (UG3 PROJECT PHASE), AND PRELIMINARY EFFICACY IN A PHASE 2A MULTIDOSE STUDY; AND (2) FURTHER DEVELOP THE EFFICACY AND SAFETY DATA FOR AP007 IN HUMAN SUBJECTS IN PHASE 2 STUDIES, AND (3) INITIATE A PHASE 3 PIVOTAL EFFICACY CLINICAL STUDY (UH3 PROJECT PHASE). THE PROPOSED EFFICACY STUDIES WILL COMPARE EFFICACY OF AP007 WITH VIVITROL®, A MONTHLY INJECTION OF NALTREXONE CURRENTLY APPROVED FOR TREATMENT OF OUD. THROUGHOUT THE PROJECT, EMERGENT WILL LEVERAGE ITS EXPERIENCE DEVELOPING THERAPEUTICS TO MEET WITH THE FDA AND ALIGN THE DEVELOPMENT APPROACH WITH FDA GUIDANCE. DEPENDING ON THE RESULTS OF THIS PROJECT, EMERGENT INTENDS TO COMPLETE THE PHASE 3 STUDY AND SUBMIT THE RESULTS IN A NEW DRUG APPLICATION PACKAGE TO SUPPORT POTENTIAL LICENSURE OF AP007 AS A LONG-ACTING THERAPEUTIC TO HELP REDUCE OPIOID CRAVINGS BECAUSE OF ADDICTION. SUCH A TREATMENT IS INTENDED TO INCREASE ADHERENCE AND REDUCE RISK OF RELAPSE FOR PATIENTS WITH OUD. 1
$0
8/2/21
Not listed
NALMEFENE LONG-ACTING INJECTABLE (AP007) FOR THE TREATMENT OF OPIOID USE DISORDER - PROJECT SUMMARY/ABSTRACT THE CURRENT OPIOID EPIDEMIC IS ONE OF THE MOST IMPORTANT PUBLIC HEALTH ISSUES IN THE UNITED STATES RESULTING IN INCREASED RELATED DISEASE, DISABILITY, AND DEATHS. AT LEAST TWO MILLION PEOPLE IN THE NATION HAVE AN OPIOID USE DISORDER (OUD). ALTHOUGH MEDICATIONS ARE AVAILABLE AS PART OF THE TREATMENT PARADIGM FOR OUD, ADHERENCE WITH TREATMENT PROGRAMS REMAINS A PROBLEM. EMERGENT IS DEVELOPING AN EXTENDED-RELEASE MICROPARTICLE FORMULATION OF NALMEFENE (AP007) FOR THE POTENTIAL TREATMENT OF OUD. NALMEFENE IS AN OPIOID RECEPTOR ANTAGONIST THAT WAS PREVIOUSLY APPROVED FOR TREATMENT OF OPIOID OVERDOSE-INDUCED RESPIRATORY DEPRESSION. IN CONTRAST TO OTHER OPIOID ANTAGONISTS, NALMEFENE HAS A LONGER DURATION OF ACTION. AP007 IS A UNIQUE FORMULATION COMPRISING OF NALMEFENE-LOADED POLY(LACTIC-CO-GLYCOLIC ACID) (PLGA) MICROPARTICLES. WHEN INJECTED INTRAMUSCULARLY, AP007 IS DESIGNED TO ACT AS A "DRUG DEPOT" WITH THE PURPOSE OF CONTINUALLY RELEASING AN EFFECTIVE DOSE OF NALMEFENE AND THUS REDUCE CRAVINGS FOR OPIOIDS IN PATIENTS WITH OUD. REDUCTION OF CRAVINGS CAN HELP PEOPLE WHO HAVE ALREADY STOPPED USING OPIOIDS REMAIN DRUG-FREE. EMERGENT IS CURRENTLY DEVELOPING AP007 AND WILL HAVE A LEAD FORMULATION SELECTED BASED ON IN VITRO RELEASE KINETICS DATA AND IN VIVO PHARMACOKINETICS DATA IN RATS BY THE START OF THE PROJECT. THE OBJECTIVES OF THE PROPOSED PROJECT ARE TO: (1) DETERMINE SAFETY AND EFFICACY OF AP007 IN A SWINE OPIOID USE/WITHDRAWAL MODEL, PRELIMINARY SAFETY IN A FIRST- IN-HUMAN PHASE 1 STUDY (UG3 PROJECT PHASE), AND PRELIMINARY EFFICACY IN A PHASE 2A MULTIDOSE STUDY; AND (2) FURTHER DEVELOP THE EFFICACY AND SAFETY DATA FOR AP007 IN HUMAN SUBJECTS IN PHASE 2 STUDIES, AND (3) INITIATE A PHASE 3 PIVOTAL EFFICACY CLINICAL STUDY (UH3 PROJECT PHASE). THE PROPOSED EFFICACY STUDIES WILL COMPARE EFFICACY OF AP007 WITH VIVITROL®, A MONTHLY INJECTION OF NALTREXONE CURRENTLY APPROVED FOR TREATMENT OF OUD. THROUGHOUT THE PROJECT, EMERGENT WILL LEVERAGE ITS EXPERIENCE DEVELOPING THERAPEUTICS TO MEET WITH THE FDA AND ALIGN THE DEVELOPMENT APPROACH WITH FDA GUIDANCE. DEPENDING ON THE RESULTS OF THIS PROJECT, EMERGENT INTENDS TO COMPLETE THE PHASE 3 STUDY AND SUBMIT THE RESULTS IN A NEW DRUG APPLICATION PACKAGE TO SUPPORT POTENTIAL LICENSURE OF AP007 AS A LONG-ACTING THERAPEUTIC TO HELP REDUCE OPIOID CRAVINGS BECAUSE OF ADDICTION. SUCH A TREATMENT IS INTENDED TO INCREASE ADHERENCE AND REDUCE RISK OF RELAPSE FOR PATIENTS WITH OUD. 1
$0
8/2/21
Grant Number
Description
Subgrantee
Prime Award
Dollars Obligated
(Click to sort descending)
Updated At
(Click to sort ascending)
4500075461S
Three 20g Scale Batches and Testing, Dose Verification Testing, Revex® Control Preparation and Testing
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Cooperative Agreement UG3DA048745
$76.5k
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4500078000S
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Charles River Laboratories, Inc.
Cooperative Agreement UG3DA048745
$1.4m
10/21/20
4500069185S
Completion of analytical characterization of improved Nalmefene microparticles including in vitro release testing. Execution of a Nalmefene API bridging study with API from Mallinckrodt. Activities include preparation of one batch of Nalmefene microparticles. Execute three 20g scale batches, including analytical characterization and testing. Each batch will be tested for IVR, content/purity, particle size, and DSC. Dose verification
Evonik Corporation
Cooperative Agreement UG3DA048745
$129.5k
5/18/20