# COPA, an Automated Medication Dispensing and Remote Management System for at Home Methadone Dispensing - Administrative Supplement

> **NIH NIH R44** · BERKSHIRE BIOMEDICAL CORPORATION · 2024 · $149,650

## Abstract

Methadone maintenance reduces and/or eliminates the use of opioids, reduces the death rates and
criminality associated with opioid use, and allows patients to improve their health and social productivity.
In addition, enrollment in Methadone Maintenance Treatment (MMT) can reduce the transmission of
infectious diseases associated with opioid injection, such as hepatitis and HIV. Our Fast-Track award
was designed to foster the development of the Computerized Oral Prescription Administration System
(COPATM), an automated oral liquid dispensing system. COPA is specifically intended for the delivery of
liquid-oral controlled and non-controlled medications to the intended user based upon the device’s dual
biometric confirmation of both the patient’s fingerprint and dentition before delivery. Following our Fast
Track submission in January 2021 and subsequent initial Notice of Award in July 2022, Berkshire had a
final Pre-Submission meeting with the FDA on October 11, 2022, to review the Company’s planned
chemical/toxicological testing. While FDA concurred with many elements of the plan, their feedback also
posed safety concerns for our novel device that required expansion of our device testing and regulatory
filing plan. To address the FDA requirements, additional research is necessary, which will include
expanded a chemical and microbiological tests plan, which is more complex, highly customized,
significantly more costly, and time-consuming than anticipated in the Company’s original submission.
Additional device processes and research validations are required to assess; (1) Continued anti-microbial
effectiveness of the agents in oral liquid formulations designed to minimize microbial proliferation when
filled, stored, and dispensed through our COPA device and (2) Interior Fluidic Path Reprocessing Efficacy
(cleaning and intermediate level disinfection). These additional FDA concerns also resulted in a cascade
of updates/changes to the device software, device file documentation, Instructions for Use documents,
internal bench testing protocols, the design of the human factors study, and the need to produce more
than the originally expected number of devices to complete all tasks prior to the FDA submission. An
Administrative Supplement is requested to provide financial support for this expanded research work
required to meet FDA expectations.

## Key facts

- **NIH application ID:** 10876799
- **Project number:** 3R44DA057185-03S1
- **Recipient organization:** BERKSHIRE BIOMEDICAL CORPORATION
- **Principal Investigator:** John Timberlake
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $149,650
- **Award type:** 3
- **Project period:** 2022-08-01 → 2025-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10876799

## Citation

> US National Institutes of Health, RePORTER application 10876799, COPA, an Automated Medication Dispensing and Remote Management System for at Home Methadone Dispensing - Administrative Supplement (3R44DA057185-03S1). Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/grant/nih/10876799. Licensed CC0.

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