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Novel Therapeutics for Opioid Use Disorder in the Acute Overdose and Maintenance Settings

Award Number: UH3DA049598
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: 08/31/2026

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Novel Therapeutics for Opioid Use Disorder in the Acute Overdose and Maintenance Settings - Abstract Opioid drugs like morphine, codeine, and fentanyl confer life-saving analgesia for millions, enabling otherwise impossible medical interventions. These benefits are offset by dose limiting liabilities, including respiratory depression - the cause of all opioid deaths - and opioid use disorder (OUD). OUD reflects a cycle of increasing use, dependence, and withdrawal that eventually triggers a respiratory crisis. The CDC estimates that 72,000 Americans died in opioid overdose last year, the leading cause of death in adults under 50. Many of these deaths arise from overdoses (OD) of potent opioids like fentanyl and carfentanyl. While naloxone can restore breathing, its short half-life requires multiple administrations to reverse OD, and may result in relapse after initial reversal, as naloxone is eliminated while the illicit drug persists. Further, the anguish of precipitated withdrawal prompts rapid, and exceedingly dangerous, return to drug-seeking. Beyond OD reversal, the standard of care in OUD is maintenance treatment with agonists buprenorphine and methadone. Both reduce relapses and mortality, but access and adoption are limited by dosage forms, metabolic liabilities, and potential for abuse and diversion. Better medicines for overdose reversal and for OUD maintenance are urgently needed. Here we develop chemically novel, potent mu-opioid receptor (MOR) antagonists, low- and mid-efficacy partial agonists. Our current lead counds can outcompete opioid overdoses in preclinical models with a longer half-life, a key naloxone liability. The potent, low-efficacy partial agonists add a low opioid tone, diminishing the aversive effects of pure antagonists. These, and the mid-efficacy partial agonists, are leads to maintenance therapeutics for OUD.


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: 2026 ( Subtotal = $0 )
2026	2023	EPIODYNE, INC.	953 INDIANA ST	SAN FRANCISCO	CA	94107	SAN FRANCISCO	USA	Drug Use and Addiction Research Programs	000	3	2/5/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2023	EPIODYNE, INC.	953 INDIANA ST	SAN FRANCISCO	CA	94107	SAN FRANCISCO	USA	Drug Use and Addiction Research Programs	000	3	10/29/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	EPIODYNE, INC.	953 INDIANA ST	SAN FRANCISCO	CA	94107	SAN FRANCISCO	USA	Drug Use and Addiction Research Programs	001	3	6/6/2024	NON-COMPETING CONTINUATION	$0
2024	2023	EPIODYNE, INC.	953 INDIANA ST	SAN FRANCISCO	CA	94107	SAN FRANCISCO	USA	Drug Use and Addiction Research Programs	000	3	1/11/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $1,549,446 )
2023	2023	EPIODYNE, INC.	953 INDIANA ST	SAN FRANCISCO	CA	94107	SAN FRANCISCO	USA	Drug Use and Addiction Research Programs	000	3	8/14/2023	NON-COMPETING CONTINUATION	$1,549,446
														Subtotal = $1,549,446

Issue Date FY: 2022 ( Subtotal = $2,594,546 )
2022	2022	EPIODYNE INC	953 INDIANA ST	SAN FRANCISCO	CA	94107	SAN FRANCISCO	USA	Drug Use and Addiction Research Programs	000	2	9/15/2022	EXTENSION WITH OR WITHOUT FUNDS	$2,594,546
														Subtotal = $2,594,546

Grand Total All Awards = $4,143,992

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Novel Therapeutics for Opioid Use Disorder in the Acute Overdose and Maintenance Settings

Award Number: UH3DA049598

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: 08/31/2026

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