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The long-term reduction of pain and opioid usage following mastectomy and tissue expander/implant surgery with a single administration of brivoligide, a non-opioid, disease-modifying drug candidate

Award Number: UG3DA048375
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: 12/15/2018
PERIOD OF PERFORMANCE END DATE: 05/31/2021

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The long-term reduction of pain and opioid usage following mastectomy and tissue expander/implant surgery with a single administration of brivoligide, a non-opioid, disease-modifying drug candidate - RESEARCH & RELATED Other Project Information Project Summary/Abstract This proposal is entitled “The long-term reduction of pain and opioid usage following mastectomy and tissue expander/implant surgery with a single administration of brivoligide, a non-opioid, disease-modifying drug candidate.” Brivoligide is a non- opioid drug candidate that can alter the course of postoperative pain for patients most likely to suffer increased pain and utilize more opioids following surgery. These patients are identified in advance of surgery using the well-validated Pain Catastrophizing Scale (PCS). A single administration of brivoligide at the time of surgery can reduce acute postoperative pain in these patients by 30 to 40% beyond what can be achieved with current standard of care for at least 28 days and reduce opioid utilization by 40% over a three-month period following surgery, an amount equal to more than 90 opioid tablets (5 mg hydrocodone) per patient. Based on the patient population treatable by brivoligide, this could translate to a reduction of up to 360 million tablets in the US annually. Brivoligide addresses the objective of the FOA to prevent and reduce opioid use disorder (OUD) by reducing the need for opioid analgesia and preventing the escalation of opioid dosing in patients at greater risk of using more opioids following surgery. To achieve regulatory approval of brivoligide with a broad indication for the reduction of postoperative pain in this patient population, the FDA requires evidence of brivoligide efficacy in one orthopedic and one soft-tissue model of postoperative pain. Brivoligide has been studied in three Phase 2 trials in patients undergoing total knee arthroplasty, an orthopedic model of postoperative pain. Grant funding will allow studying brivoligide in mastectomy, a soft-tissue surgery model suitable to detect long-term pain and opioid reduction benefits. The UG3 portion of the grant will specifically fund a 126-subject, randomized, double-blind, placebo-controlled Phase 2 trial in patients undergoing mastectomy with immediate tissue expander or implant placement. Following an End-of- Phase 2 meeting with the FDA, the UH3 portion will fund a subsequent pivotal Phase 3 mastectomy trial. The Phase 2 and 3 studies will focus on both pain reduction and opioid reduction in subjects with elevated scores on the PCS.


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: 2021 ( Subtotal = -$1,524,390 )
2021	2020	ADYNXX SUB, INC.	44 TEHAMA ST	SAN FRANCISCO	CA	94105	SAN FRANCISCO	USA	Drug Use and Addiction Research Programs	000	2	12/10/2020	NON-COMPETING CONTINUATION	$0
2021	2020	ADYNXX SUB, INC.	44 TEHAMA ST	SAN FRANCISCO	CA	94105	SAN FRANCISCO	USA	Drug Use and Addiction Research Programs	001	2	8/23/2021	NON-COMPETING CONTINUATION	-$1,524,390
														Subtotal = -$1,524,390

Issue Date FY: 2020 ( Subtotal = $2,858,544 )
2020	2020	ADYNXX SUB, INC.	44 TEHAMA ST	SAN FRANCISCO	CA	94105	SAN FRANCISCO	USA	Drug Use and Addiction Research Programs	002	2	9/8/2020	NON-COMPETING CONTINUATION	$0
2020	2020	ADYNXX, INC.	100 PINE ST STE 500	SAN FRANCISCO	CA	94111	SAN FRANCISCO	USA	Drug Use and Addiction Research Programs	000	2	12/12/2019	NON-COMPETING CONTINUATION	$2,572,690
2020	2020	ADYNXX, INC.	100 PINE ST STE 500	SAN FRANCISCO	CA	94111	SAN FRANCISCO	USA	Drug Use and Addiction Research Programs	001	2	2/10/2020	NON-COMPETING CONTINUATION	$285,854
														Subtotal = $2,858,544

Issue Date FY: 2019 ( Subtotal = $2,858,544 )
2019	2019	ADYNXX, INC.	100 PINE ST STE 500	SAN FRANCISCO	CA	94111	SAN FRANCISCO	USA	Drug Use and Addiction Research Programs	000	1	12/7/2018	NEW	$2,858,544
														Subtotal = $2,858,544

Grand Total All Awards = $4,192,698

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The long-term reduction of pain and opioid usage following mastectomy and tissue expander/implant surgery with a single administration of brivoligide, a non-opioid, disease-modifying drug candidate

Award Number: UG3DA048375

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: 12/15/2018

PERIOD OF PERFORMANCE END DATE: 05/31/2021

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