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

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.