Berkshire Biomedical Corporation has secured a competitive two-phase Fast-Track Small Business Innovation Research (SBIR) grant worth approximately $2.9 million from the National Institutes of Health's National Institute of Drug Abuse (NIDA) to support clinical evaluation of its biometric medication dispensing technology for opioid use disorder treatment.
The grant (1 R44DA061908-01A1) will fund a clinical study evaluating patient retention and other benefits of the company's COPA™ System for Take-Home Methadone Medication Management as part of Medication for Opioid User Disorder (MOUD) treatment over 30 months.
Phased Study Design
Phase I will receive approximately $326,400 to support execution of a single-site study. The larger Phase II component, valued at approximately $2.55 million, will fund an open-label, randomized, parallel multi-site study, contingent on successful Phase I results and continued NIH funding availability.
Biometric Authentication Technology
The COPA System represents a novel approach to controlled medication dispensing, utilizing dual biometric identification through fingerprint and dentition recognition. The hand-held, automated oral liquid dispensing system is designed to deliver accurate and precise doses of controlled and non-controlled prescription medications exclusively to an Authenticated Intended User (AIU™) upon biometric confirmation prior to each dose.
"The Fast-Track SBIR grant process is highly competitive, with only 18% of applicants having been chosen under this program in 2023, alone," stated John Timberlake, Chief Executive Officer of Berkshire Biomedical Corporation.
Addressing Treatment Retention Challenges
The clinical study addresses a significant barrier in opioid use disorder treatment. According to Timberlake, "The requirement to travel to an Opioid Treatment Program (OTP) clinic, daily, has been shown to reduce treatment retention and deter some patients from even starting treatment."
Research cited by the company indicates that take-home dose flexibility among stable patients was associated with receiving more take homes, higher rates of treatment retention, and lower rates of opioid-positive drug tests. Higher retention rates in opioid use disorder medication among patients with OUD were associated with better outcomes.
Continued Federal Support
This award marks Berkshire's second Fast-Track SBIR Grant from NIH. The company previously received a two-phased award totaling $2.2 million (1R44DA057185) in 2022, which extended through 2024 to complete development of the COPA system.
"Berkshire's receipt of this newest award reflects the NIH's continued belief in the strength of the technology behind COPA and its potential to significantly increase access to Opioid Treatment Programs for persons suffering from Opioid Use Disorder (OUD) by dramatically increasing the number of persons being allowed to utilize take home therapy," Timberlake explained.
Research Gap and Clinical Need
The company notes a significant gap in current research methodology for opioid use disorder treatment evaluation. "There have been a considerable number of retrospective studies evaluating opioid use disorder treatment retention; however, there are very few prospective comparison studies," according to Timberlake.
Future Applications
Beyond methadone delivery for opioid use disorder treatment, Berkshire plans to expand COPA's applications to controlled medications for pain treatment and broader drug therapeutic categories. The company intends to leverage the system's remote monitoring capabilities and data analytics to improve patient outcomes and reduce risk across various clinical applications.
The COPA™ System remains under development and has not been reviewed by the U.S. Food and Drug Administration, with no current commercial availability.
