SBIR-STTR Award

COPA, an Automated Medication Dispensing and Remote Management System for at Home Methadone Dispensing
Award last edited on: 2/5/2024

Sponsored Program
SBIR
Awarding Agency
NIH : NIDA
Total Award Amount
$1,830,405
Award Phase
2
Solicitation Topic Code
279
Principal Investigator
John Timberlake

Company Information

Berkshire Biomedical Corporation

5950 Berkshire Lane Suite 375
Dallas, TX 75225
   (214) 389-1748
   N/A
   www.berkshirebiomedical.com
Location: Single
Congr. District: 24
County: Dallas

Phase I

Contract Number: 1R44DA057185-01
Start Date: 8/1/2022    Completed: 1/31/2023
Phase I year
2022
Phase I Amount
$266,048
Methadone maintenance reduces and/or eliminates the use of opioids, reduces the death ratesand criminality associated with opioid use, and allows patients to improve their health and socialproductivity. In addition, enrollment in Methadone Maintenance Treatment (MMT) can reduce thetransmission of infectious diseases associated with opioid injection, such as hepatitis and HIV.The Computerized Oral Prescription Administration System (COPATM) device is being developedas an automated oral liquid dispensing system. COPA is specifically designed to deliver liquidoral controlled and non-controlled medications to the validated Intended User. While the need forCOPA began with an opioid epidemic with adverse consequences that have escalated in the lasttwo decades, an even more urgent need for a take-home device supporting opioid use disorder(OUD) patients emerged at the onset of the COVID-19 pandemic. The pandemic has limitedaccess to methadone maintenance therapy/treatment at opioid treatment programs in both urbanand rural sections of the US. The COPA device has a major application to at-home methadonemaintenance treatment, based upon the device's innovative dual biometric confirmation of boththe patient's fingerprint and dentition before delivery of drug. We propose to design, engineer andhuman factor test an enhanced COPA prototype and submit it for FDA De Novo approval.

Public Health Relevance Statement:
NARRATIVE The Computerized Oral Prescription Administration System (COPATM) device is being developed as an automated oral liquid dispensing system for at-home methadone maintenance therapy (MMT). The COPA device has a major application to at-home MMT based upon the device's innovative dual biometric confirmation of both the patient's fingerprint and dentition before delivery of drug to the Intended User.

Project Terms:

Phase II

Contract Number: 4R44DA057185-02
Start Date: 8/1/2022    Completed: 7/31/2024
Phase II year
2023
Phase II Amount
$1,564,357
Methadone maintenance reduces and/or eliminates the use of opioids, reduces the death ratesand criminality associated with opioid use, and allows patients to improve their health and socialproductivity. In addition, enrollment in Methadone Maintenance Treatment (MMT) can reduce thetransmission of infectious diseases associated with opioid injection, such as hepatitis and HIV.The Computerized Oral Prescription Administration System (COPATM) device is being developedas an automated oral liquid dispensing system. COPA is specifically designed to deliver liquidoral controlled and non-controlled medications to the validated Intended User. While the need forCOPA began with an opioid epidemic with adverse consequences that have escalated in the lasttwo decades, an even more urgent need for a take-home device supporting opioid use disorder(OUD) patients emerged at the onset of the COVID-19 pandemic. The pandemic has limitedaccess to methadone maintenance therapy/treatment at opioid treatment programs in both urbanand rural sections of the US. The COPA device has a major application to at-home methadonemaintenance treatment, based upon the device's innovative dual biometric confirmation of boththe patient's fingerprint and dentition before delivery of drug. We propose to design, engineer andhuman factor test an enhanced COPA prototype and submit it for FDA De Novo approval.

Public Health Relevance Statement:
NARRATIVE The Computerized Oral Prescription Administration System (COPATM) device is being developed as an automated oral liquid dispensing system for at-home methadone maintenance therapy (MMT). The COPA device has a major application to at-home MMT based upon the device's innovative dual biometric confirmation of both the patient's fingerprint and dentition before delivery of drug to the Intended User.

Project Terms: