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Longer-acting intravaginal formulation of buprenorphine

Award Number: R44DA053073
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/30/2020
PERIOD OF PERFORMANCE END DATE: 08/31/2024

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Longer-acting intravaginal formulation of buprenorphine - PROJECT SUMMARY The broad, long-term goal of this research program is to empower women suffering from opioid use disorder (OUD) through the development of a long-acting intravaginal ring (IVR) formulation of the opioid partial agonist -buprenorphine (BUP). This proposal is in response to RFA-DA-19-019 which calls for solutions to develop “Longer-acting formulations of existing addiction medications”. The current armamentarium of BUP-based drug products for the treatment of OUD includes daily sublingual, monthly injectable, and bi-annual implantable formulations. The year-over-year increase in these prescriptions suggest that improved BUP medications hold significant potential for improving patient retention, and overall healthcare outcomes. Despite their usefulness, both immediate-release and long-acting BUP formulations demonstrate sub-optimal pharmacokinetic (PK) profiles displaying an initial burst release followed by plateauing. The daily formulations often suffer from adherence/compliance issues and contain 5-10X more drug loading than required, creating diversion potential. Long-acting injectable and implantable medications are invasive, and require HCP visits for administration. To address this unmet need, we propose a “fast-track” IND-enabling approach to develop a monthly IVR delivering BUP using our established drug delivery technology. The commercial success of the contraceptive IVR Nuvaring® provides an applicable case study. More than 1 million women choose IVRs over traditional methods: more than long-acting implants or patches. We expect that a BUP ring will be chosen by a significant percentage of women seeking treatment for OUD. Our team has experience formulating IVRs to deliver a wide variety of small and large molecules using our “pod” technology. This work has resulted in three IND approvals in the fields of HIV pre-exposure prophylaxis (PrEP) and the treatment of genital herpes. In preliminary work, we developed a pilot BUP pod-IVR and tested it in vitro to confirm its formulation feasibility. We confirmed that BUP is vaginally bioavailable in a sheep model. PK modeling indicates that our pod-IVR can maintain therapeutic plasma levels at a substantially reduced dose and diversion potential. The specific aims of Phase 1 are to develop lead formulations across a broad range of release targets and to perform safety and PK testing in sheep. The milestone for successful completion of Phase 1 will be the demonstration of safety and clinically relevant drug concentrations from the animal study. In Phase 2, the specific aims will be: to carry out all of the necessary work in chemistry, manufacturing and controls (CMC); pre-clinical animal studies; and protocol development to allow the milestone: Investigational New Drug (IND) allowance from the FDA allowing the first-in-human testing of a BUP pod-IVR. Following successful completion of this project, we will seek funding to carry out a series of clinical studies to further demonstrate safety, PK, and efficacy. The development of this product will provide women a novel, private and improved therapeutic adjunct in the treatment of opiate addiction with reduced risk for diversion.


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: 2025 ( Subtotal = $0 )
2025	2022	AURITEC PHARMACEUTICALS, INC.	2285 E FOOTHILL BLVD	PASADENA	CA	91107	LOS ANGELES	USA	Drug Use and Addiction Research Programs	000	3	12/24/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2020	AURITEC PHARMACEUTICALS, INC.	2285 E FOOTHILL BLVD	PASADENA	CA	91107	LOS ANGELES	USA	Drug Use and Addiction Research Programs	000	1	11/13/2022	NEW	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $845,335 )
2022	2022	AURITEC PHARMACEUTICALS, INC.	2285 E FOOTHILL BLVD	PASADENA	CA	91107	LOS ANGELES	USA	Drug Use and Addiction Research Programs	001	3	8/17/2022	NON-COMPETING CONTINUATION	$845,335
2022	2021	AURITEC PHARMACEUTICALS, INC.	2285 E FOOTHILL BLVD	PASADENA	CA	91107	LOS ANGELES	USA	Drug Use and Addiction Research Programs	000	2	11/16/2021	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $845,335

Issue Date FY: 2021 ( Subtotal = $900,251 )
2021	2021	AURITEC PHARMACEUTICALS, INC.	2285 E FOOTHILL BLVD	PASADENA	CA	91107	LOS ANGELES	USA	Drug Use and Addiction Research Programs	000	1	4/16/2021	SUPPLEMENT FOR EXPANSION	$54,916
2021	2021	AURITEC PHARMACEUTICALS, INC.	2285 E FOOTHILL BLVD	PASADENA	CA	91107	LOS ANGELES	USA	Drug Use and Addiction Research Programs	001	2	8/20/2021	EXTENSION WITH OR WITHOUT FUNDS	$845,335
														Subtotal = $900,251

Issue Date FY: 2020 ( Subtotal = $253,692 )
2020	2020	AURITEC PHARMACEUTICALS, INC.	2285 E FOOTHILL BLVD	PASADENA	CA	91107	LOS ANGELES	USA	Drug Use and Addiction Research Programs	000	1	9/21/2020	NEW	$253,692
														Subtotal = $253,692

Grand Total All Awards = $1,999,278

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Longer-acting intravaginal formulation of buprenorphine

Award Number: R44DA053073

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/30/2020

PERIOD OF PERFORMANCE END DATE: 08/31/2024

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