UG3DA062511
Cooperative Agreement
Overview
Grant Description
Development of a bioabsorbable, subcutaneous, extended-release buprenorphine implant for opioid use disorder - Project summary/abstract
The Drug Delivery Company (DDC) is developing a bioabsorbable, extended-release buprenorphine implant.
It is intended to help address the challenges posed by opioid use disorder (OUD) and the fentanyl overdose crisis.
Currently, the longest-lasting formulation of buprenorphine (BUP) is a one-month long-acting injection (Sublocade® and Brixadi®).
An extended-release buprenorphine (XR-BUP) implant, capable of releasing therapeutic levels of BUP for over 6 months, will improve medication compliance and provide a new treatment option for patients and healthcare providers.
In collaboration with the National Institute on Drug Abuse (NIDA), DDC has been actively involved in developing a subcutaneous, bioabsorbable, extended-release 6-month naltrexone (NTX) implant since 2019.
Building upon the success of the 6-month bioabsorbable naltrexone implant, known as the ISTEP-N®, DDC is now creating a 6-month bioabsorbable buprenorphine implant using the same technology.
The ISTEP-N® utilizes a patented bioabsorbable drug delivery platform, which is protected by U.S. Patent No. 11,197,819.
In pre-clinical studies, the ISTEP-N® implants demonstrated the release of therapeutic plasma levels of NTX for over 7 months in canines with a mean plasma concentration of 5.3 ng/ml, with detectable levels persisting for more than 8 months.
The ISTEP-N® was well-tolerated, and no adverse events were reported.
The FDA granted an Investigational New Drug (IND) approval without clinical hold [IND 152127] for the ISTEP-N®, allowing the company to commence a Phase I clinical trial in healthy volunteers (Q2 of 2024).
The development plan for the XR-BUP implant (ISTEP-B) will be to follow the roadmap that was used for the ISTEP-N® naltrexone implant.
The chemical similarities between NTX and BUP allow for the loading of BUP into the ISTEP-N® drug delivery platform.
This study is targeting the same plasma concentration for both the NTX and BUP implants, which is > 2-4 ng/ml throughout the entire 6-month duration of the implant.
At this stage, there should only be minor adjustments made to the methodology used in developing the ISTEP-N® naltrexone implant.
The development process for the bioabsorbable, extended-release buprenorphine implant will follow the same pathway, including implant formulation, chemistry, manufacturing, and controls (CMC) analytics, non-GLP animal studies, GLP IND-enabling toxicology studies in rodents and canines, submission of the IND application to the FDA, and ultimately the completion of Phase I and Phase II clinical trials.
The effectiveness of a 6-month buprenorphine implant is expected to provide stability and support for OUD patients during those critical initial six months of recovery.
Subsequently, with only two annual office visits required for a new XR-BUP implant, patients can focus on psychosocial therapy, recovery, and rebuilding their lives.
An XR-BUP implant, releasing therapeutic buprenorphine for over 6 months, will enhance medication compliance and offers a fresh solution to opioid use disorder and the fentanyl overdose crisis.
The Drug Delivery Company (DDC) is developing a bioabsorbable, extended-release buprenorphine implant.
It is intended to help address the challenges posed by opioid use disorder (OUD) and the fentanyl overdose crisis.
Currently, the longest-lasting formulation of buprenorphine (BUP) is a one-month long-acting injection (Sublocade® and Brixadi®).
An extended-release buprenorphine (XR-BUP) implant, capable of releasing therapeutic levels of BUP for over 6 months, will improve medication compliance and provide a new treatment option for patients and healthcare providers.
In collaboration with the National Institute on Drug Abuse (NIDA), DDC has been actively involved in developing a subcutaneous, bioabsorbable, extended-release 6-month naltrexone (NTX) implant since 2019.
Building upon the success of the 6-month bioabsorbable naltrexone implant, known as the ISTEP-N®, DDC is now creating a 6-month bioabsorbable buprenorphine implant using the same technology.
The ISTEP-N® utilizes a patented bioabsorbable drug delivery platform, which is protected by U.S. Patent No. 11,197,819.
In pre-clinical studies, the ISTEP-N® implants demonstrated the release of therapeutic plasma levels of NTX for over 7 months in canines with a mean plasma concentration of 5.3 ng/ml, with detectable levels persisting for more than 8 months.
The ISTEP-N® was well-tolerated, and no adverse events were reported.
The FDA granted an Investigational New Drug (IND) approval without clinical hold [IND 152127] for the ISTEP-N®, allowing the company to commence a Phase I clinical trial in healthy volunteers (Q2 of 2024).
The development plan for the XR-BUP implant (ISTEP-B) will be to follow the roadmap that was used for the ISTEP-N® naltrexone implant.
The chemical similarities between NTX and BUP allow for the loading of BUP into the ISTEP-N® drug delivery platform.
This study is targeting the same plasma concentration for both the NTX and BUP implants, which is > 2-4 ng/ml throughout the entire 6-month duration of the implant.
At this stage, there should only be minor adjustments made to the methodology used in developing the ISTEP-N® naltrexone implant.
The development process for the bioabsorbable, extended-release buprenorphine implant will follow the same pathway, including implant formulation, chemistry, manufacturing, and controls (CMC) analytics, non-GLP animal studies, GLP IND-enabling toxicology studies in rodents and canines, submission of the IND application to the FDA, and ultimately the completion of Phase I and Phase II clinical trials.
The effectiveness of a 6-month buprenorphine implant is expected to provide stability and support for OUD patients during those critical initial six months of recovery.
Subsequently, with only two annual office visits required for a new XR-BUP implant, patients can focus on psychosocial therapy, recovery, and rebuilding their lives.
An XR-BUP implant, releasing therapeutic buprenorphine for over 6 months, will enhance medication compliance and offers a fresh solution to opioid use disorder and the fentanyl overdose crisis.
Awardee
Funding Goals
TO SUPPORT BASIC AND CLINICAL NEUROSCIENCE, BIOMEDICAL, BEHAVIORAL AND SOCIAL SCIENCE, EPIDEMIOLOGIC, HEALTH SERVICES AND HEALTH DISPARITY RESEARCH. TO DEVELOP NEW KNOWLEDGE AND APPROACHES RELATED TO THE PREVENTION, DIAGNOSIS, TREATMENT, ETIOLOGY, AND CONSEQUENCES OF DRUG ABUSE AND ADDICTION, INCLUDING HIV/AIDS. TO SUPPORT RESEARCH TRAINING AND RESEARCH SCIENTIST DEVELOPMENT. TO SUPPORT DISSEMINATION OF RESEARCH FINDINGS. SMALL BUSINESS INNOVATION RESEARCH (SBIR) LEGISLATION IS INTENDED TO EXPAND AND IMPROVE THE SBIR PROGRAMS TO EMPHASIZE AND INCREASE PRIVATE SECTOR COMMERCIALIZATION OF TECHNOLOGY DEVELOPED THROUGH FEDERAL SBIR RESEARCH AND DEVELOPMENT, INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN THE SBIR PROGRAM. THE LEGISLATION INTENDS THAT THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.
Grant Program (CFDA)
Awarding / Funding Agency
Place of Performance
Maryland
United States
Geographic Scope
State-Wide
Akyso Therapeutics was awarded
Cooperative Agreement UG3DA062511
worth $2,932,500
from National Institute on Drug Abuse in August 2025 with work to be completed primarily in Maryland United States.
The grant
has a duration of 2 years and
was awarded through assistance program 93.279 Drug Abuse and Addiction Research Programs.
The Cooperative Agreement was awarded through grant opportunity Development of Medications to Prevent and Treat Opioid and/or Stimulant Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional).
Status
(Ongoing)
Last Modified 7/25/25
Period of Performance
8/1/25
Start Date
7/31/27
End Date
Funding Split
$2.9M
Federal Obligation
$0.0
Non-Federal Obligation
$2.9M
Total Obligated
Activity Timeline
Additional Detail
Award ID FAIN
UG3DA062511
SAI Number
UG3DA062511-1420599288
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Small Business
Awarding Office
75N600 NIH National Insitute on Drug Abuse
Funding Office
75N600 NIH National Insitute on Drug Abuse
Awardee UEI
WMJ6UFULU731
Awardee CAGE
83GL0
Performance District
MD-90
Senators
Benjamin Cardin
Chris Van Hollen
Chris Van Hollen
Modified: 7/25/25