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Nalmefene Implant for the Long-Term Treatment of Opioid Use Disorder

Award Number: UH3DA047707
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: 09/15/2018
PERIOD OF PERFORMANCE END DATE: 01/31/2028

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Nalmefene Implant for the Long-Term Treatment of Opioid Use Disorder - Project Summary: Nalmefene Implant for the Long-Term Treatment of Opioid Use Disorder The U.S. currently faces a major crisis from the increasing number of deaths due to opioid overdose among Americans afflicted with the chronic medical condition called opioid use disorder (OUD). Harm from opioid misuse and addiction also comes at a huge economic cost. Pharmacotherapy for OUD with an opioid agonist, or following detoxification with an opioid antagonist, is safe and effective, and can reduce or eliminate withdrawal symptoms, blunt or block the effects of illicit opioids, and reduce or eliminate cravings. However, an OUD subject in remission has a high chance of relapse to opioid use; which can occur at any time - from a few days to months following detoxification. Prophylactic treatment with opioid antagonists can block the effect of opioid use and can be an effective treatment for preventing OUD relapse following detoxification and potential overdose death; however, low patient compliance to frequent dosing necessary to maintain brain opioid receptor blockade has prevented widespread adoption. There is an urgent unmet need for a chronic treatment paradigm capable of providing enhanced compliance for 6-months or longer to prevent OUD relapse and renarcotization in detoxified subjects. Titan's proprietary subdermal implants can provide long-term, non- fluctuating therapeutic levels of drug continuously following a single office-based insertion procedure. The non- biodegradable solid matrix implant formulation virtually eliminates the risk of accidental drug dumping and associated serious toxicity, and its subdermal location assures patient compliance for the 6-month treatment duration. Nalmefene hydrochloride (nalmefene) is an opioid receptor antagonist approved for the management and reversal of opioid overdose, including respiratory depression. Its advantage over other opioid antagonists includes higher potency, longer half-life, and no liver toxicity. Prototype nalmefene implants inserted subdermally in rats delivered nalmefene continuously for months without any observable safety concerns. The data suggests that one-three implants could potentially deliver sufficient drug to provide up to 90% blockage of human brain opioid receptors. Since nalmefene is an FDA approved drug, and because Titan's implant technology has been validated in an approved and marketed product for the maintenance treatment of OUD, the potential regulatory risk for developing this product is relatively low. Development could be cost-effective and the probability is high for successful commercialization of this product for the prevention of relapse to opioid dependence, following opioid detoxification. The objective is to develop a 6-month implantable device that delivers nalmefene around the clock at a steady rate to prevent relapse to opioid dependence following opioid detoxification. The goals are to manufacture nalmefene implants, complete nonclinical safety and pharmacology studies, and conduct clinical studies in OUD subjects to support a New Drug Application. This novel product could potentially improve effectiveness of the treatment, enhance compliance, lower individual and societal costs, and significantly contribute towards alleviating the deadly consequences of this epidemic.


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 = $3,450,000 )
2026	2026	REACX PHARMACEUTICALS, INC.	400 OYSTER POINT BLVD	SOUTH SAN FRANCISCO	CA	94080	SAN MATEO	USA	Drug Use and Addiction Research Programs	001	4	3/4/2026	NON-COMPETING CONTINUATION	$3,450,000
2026	2025	REACX PHARMACEUTICALS, INC.	400 OYSTER POINT BLVD	SOUTH SAN FRANCISCO	CA	94080	SAN MATEO	USA	Drug Use and Addiction Research Programs	000	3	1/14/2026	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $3,450,000

Issue Date FY: 2025 ( Subtotal = $3,450,000 )
2025	2025	REACX PHARMACEUTICALS, INC.	400 OYSTER POINT BLVD	SOUTH SAN FRANCISCO	CA	94080	SAN MATEO	USA	Drug Use and Addiction Research Programs	000	3	1/23/2025	EXTENSION WITH OR WITHOUT FUNDS	$3,450,000
														Subtotal = $3,450,000

Grand Total All Awards = $6,900,000

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Nalmefene Implant for the Long-Term Treatment of Opioid Use Disorder

Award Number: UH3DA047707

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: 09/15/2018

PERIOD OF PERFORMANCE END DATE: 01/31/2028

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