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Berkshire Biomedical's COPA System Undergoes FDA Review

Berkshire Biomedical Corporation, an innovative entity in the healthcare technology space, has taken a significant step forward by announcing that its De Novo application for the Computerized Oral Prescription Administration (COPA™) system has been accepted for review by the U.S. Food and Drug Administration (FDA). This application aims to enhance the accessibility and management of medications, particularly for individuals grappling with opioid use disorder and other chronic conditions.

The Importance of the COPA System

The COPA system is a groundbreaking tool designed to manage oral liquid medications in a secure and efficient manner. The device ensures that only authenticated users can access prescribed medications, utilizing dual biometric identification—fingerprints and dentition recognition. This feature aims to not only improve adherence to medication regimens but also to facilitate remote monitoring, enhancing patient wellness in the process.

Berkshire is seeking authorization for three specific medications: Methadone HCL oral solution, used for treating opioid use disorder and severe pain; Oxycodone HCL oral solution, for moderate to severe pain; and Fluoxetine HCL oral solution, for managing depression and anxiety. The review of this application is scheduled to conclude by November 2025, barring any unforeseen delays that may arise during the FDA's evaluation process.

Addressing a Critical Need

John Timberlake, CEO of Berkshire Biomedical, highlighted the pressing need for a solution that integrates the benefits of self-managed treatment plans with professional oversight. With approximately 5.7 million people in the U.S. suffering from opioid use disorder, and only 18% receiving medication treatment, the need for a functional and supportive medication management tool cannot be overstated. Current treatment models often require patients to make daily trips to opioid treatment programs, which can hinder treatment progression, discourage new patients from seeking help, and ultimately reduce retention rates.

The COPA system has the potential to revolutionize methadone take-home treatments, which could significantly increase the number of patients actively engaged in their treatment plans. Mr. Timberlake remarked, “For providers and their patients, faced with ineffective self-managed treatment plans due to adherence challenges, yet recognizing the high expense and detrimental patient impact of professionally managed plans, a solution is urgently needed.”

Support from NIH

In line with their mission, Berkshire Biomedical has also received a Fast-Track Small Business Innovation Research (SBIR) grant from the National Institutes of Health’s (NIH) National Institute on Drug Abuse (NIDA). This funding highlights NIH’s confidence in the COPA system's capabilities and the potential impact it may have in improving access to opioid treatment programs. NIDA plays a critical role in advancing addiction science through groundbreaking research and initiatives aimed at informing policy and practice in drug addiction and recovery.

Looking Ahead

Following FDA approval, Berkshire Biomedical plans to focus initially on utilizing COPA for the management of oral liquid methadone for opioid use disorder. The company also envisions future applications of the technology in the delivery and management of controlled medications for pain management, reflecting their commitment to patient-centered care.

Berkshire aims not only to improve medication adherence but also to revolutionize how health data analytics can be integrated into patient care, allowing for more personalized treatment plans and improved health outcomes. The COPA system is anticipated to set a new standard in medication management technology.

For more information about Berkshire Biomedical and the ongoing development of the COPA system, please visit www.berkbiomed.com. It is important to note that COPA has yet to receive marketing authorization from the FDA and is not currently available for sale.

As the healthcare landscape continues to evolve, innovations like the COPA system are essential for advancing medication management and ensuring that patients receive the best possible care.