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Nalmefene Long-Acting Injectable (AP007) for the Treatment of Opioid Use Disorder

Award Number: UG3DA048745
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/30/2019
PERIOD OF PERFORMANCE END DATE: 08/31/2022

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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


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2019	EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC.	300 PROFESSIONAL DR	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Drug Use and Addiction Research Programs	000	1	9/13/2023	NEW	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2019	EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC.	300 PROFESSIONAL DR	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Drug Use and Addiction Research Programs	000	1	5/25/2022	NEW	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2019	EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC.	300 PROFESSIONAL DR	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Drug Use and Addiction Research Programs	000	1	8/2/2021	NEW	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2019	EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC.	300 PROFESSIONAL DR	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Drug Use and Addiction Research Programs	001	1	7/20/2020	NEW	$0
2020	2019	EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC.	300 PROFESSIONAL DR	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Drug Use and Addiction Research Programs	000	1	11/20/2019	NEW	$0
2020	2019	EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC.	300 PROFESSIONAL DR	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Drug Use and Addiction Research Programs	002	1	9/16/2020	NEW	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $6,354,906 )
2019	2019	EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC.	300 PROFESSIONAL DR	GAITHERSBURG	MD	20879	MONTGOMERY	USA	Drug Use and Addiction Research Programs	000	1	9/25/2019	NEW	$6,354,906
														Subtotal = $6,354,906

Grand Total All Awards = $6,354,906

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Nalmefene Long-Acting Injectable (AP007) for the Treatment of Opioid Use Disorder

Award Number: UG3DA048745

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/30/2019

PERIOD OF PERFORMANCE END DATE: 08/31/2022

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