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Development of Lofexidine as a First-line Non-Opioid Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome

Award Number: UG3DA054799
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: 09/30/2021
PERIOD OF PERFORMANCE END DATE: 08/31/2025

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Development of Lofexidine as a First-line Non-Opioid Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome - PROJECT SUMMARY: An alarming increase in the rate of opioid abuse among the general population has resulted in a public health emergency since 2017. The striking rise in opioid use disorder has affected Americans broadly, including pregnant women with a resulting increase in infants born suffering from opioid withdrawal or Neonatal Opioid Withdrawal Syndrome (NOWS). The NOWS epidemic has led to significant increases in healthcare costs and burden on the healthcare system due to increased length of hospital stay and level of required care. In 2016, a normal infant averaged 3 days of hospital care post-birth costing $15,000, whereas an infant born with NOWS averaged 16.4 days of inpatient care costing $70,000. Currently, there are no FDA-approved medications available for treatment of NOWS. Current approaches to pharmacotherapy rely on the off-label use of opioids and other agents. Opioid therapy contributes to the extended hospitalization of NOWS infants as continuous monitoring for safety observations is necessary due to the risk of respiratory depression. Through a successful collaboration with NIDA, USWM developed lofexidine for the mitigation of opioid withdrawal symptoms in adults. The Food and Drug Administration (FDA) approved lofexidine tablets (LUCEMYRA®) for this indication in May 2018. Due to the anticipated utility of lofexidine for the treatment of opioid withdrawal in children, USWM has initiated a development program evaluating lofexidine for neonate patient use. Initial requirements to begin clinical trials of lofexidine for NOWS have been agreed upon with the FDA and include nonclinical safety studies, development of a pediatric-specific formulation, and an evaluation of the pharmacokinetics (PK) of the pediatric formulation in healthy adults. Through a strategic alliance with NIDA, USWM has completed or is on track to complete all prerequisites to initiate clinical testing in NOWS prior to the anticipated start of funding for the current application. USWM now proposes to extend the co-development program through investigation of the safety and efficacy of the new pediatric formulation of lofexidine in NOWS. The goal of this project is to develop lofexidine as a first-line medication for the treatment of NOWS. Use of a well-characterized, safe and effective neonatal formulation of a non-opioid therapy is expected to result in fewer patients requiring opioids and/or reduce opioid dose/duration, permitting safer treatment with shorter hospital stays. The scope of the proposed research includes chemistry, manufacturing and control (CMC) activities and the clinical development program required to support registration of the pediatric formulation for mitigation of withdrawal symptoms in patients with NOWS. Key milestones of the program include: i) a technology transfer and manufacturing activities to support late phase clinical trial material (CTM) production (UG3 Aim 1), ii) a first- in-neonate PK and dose-response study in NOWS to support dose selection and pivotal study design decisions (UG3 Aims 2 & 3), iii) manufacture of Phase 3 CTM and completion of the CMC registration package (UH3 Aim 1), and iv) a pivotal study to establish safety and efficacy of lofexidine for use in NOWS (UH3 Aims 2 & 3).


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 = -$1,328,146 )
2026	2021	USWM LLC	4441 SPRINGDALE RD	LOUISVILLE	KY	40241	JEFFERSON	USA	Drug Use and Addiction Research Programs	000	1	3/3/2026	NEW	-$1,328,146
														Subtotal = -$1,328,146

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2021	USWM LLC	4441 SPRINGDALE RD	LOUISVILLE	KY	40241	JEFFERSON	USA	Drug Use and Addiction Research Programs	000	1	8/30/2024	NEW	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2021	USWM LLC	4441 SPRINGDALE RD	LOUISVILLE	KY	40241	JEFFERSON	USA	Drug Use and Addiction Research Programs	002	1	9/13/2023	NEW	$0
2023	2021	USWM LLC	4441 SPRINGDALE RD	LOUISVILLE	KY	40241	JEFFERSON	USA	Drug Use and Addiction Research Programs	000	1	5/10/2023	NEW	$0
2023	2021	USWM LLC	4441 SPRINGDALE RD	LOUISVILLE	KY	40241	JEFFERSON	USA	Drug Use and Addiction Research Programs	001	1	5/25/2023	NEW	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	USWM, LLC	4441 SPRINGDALE RD	LOUISVILLE	KY	40241	JEFFERSON	USA	Drug Use and Addiction Research Programs	000	1	1/21/2022	NEW	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $5,353,314 )
2021	2021	USWM, LLC	4441 SPRINGDALE RD	LOUISVILLE	KY	40241	JEFFERSON	USA	Drug Use and Addiction Research Programs	000	1	9/24/2021	NEW	$5,353,314
														Subtotal = $5,353,314

Grand Total All Awards = $4,025,168

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Development of Lofexidine as a First-line Non-Opioid Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome

Award Number: UG3DA054799

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: 09/30/2021

PERIOD OF PERFORMANCE END DATE: 08/31/2025

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