Berkshire Biomedical Announces that Its De Novo Application for Marketing Authorization of Its Computerized Oral Prescription Administration (COPA™) System Has Been Accepted for Review by the FDA
Milestone Marks Critical Step Toward Bringing COPA™ to Market to Improve Access, Adherence and Outcomes in Opiod Use Disorder and Other Chronic Conditions
DALLAS, July 7, 2025 /PRNewswire/ -- Berkshire Biomedical Corporation ("Berkshire" or "the Company"), focused on developing its proprietary drug dispensing technology to enhance patient wellness, today announced that its De Novo application for marketing authorization of its COPA™ System has been accepted for review by the U.S. Food and Drug Administration (FDA). The application will be reviewed by the FDA's Division of Health Technology 3C, and has received a target decision day in November 2025, subject to any time the application is put on hold to address any questions.
The intended medications and use indications for which Berkshire is seeking marketing authorization include methadone HCL oral solution (for Opioid Use Disorder (OUD), moderate to severe pain), oxycodone HCL oral solution (for moderate to severe pain) and fluoxetine HCL oral solution (for treatment of depression, anxiety, and other central nervous system disorders).
COPA is a novel, oral liquid dispensing system specifically designed to deliver accurate and precise doses of controlled and non-controlled prescription medications to only an Authenticated Intended User (AIU™), upon confirmation of dual biometric identifications (fingerprint and dentition) prior to each dose, with the goal of enhancing patient wellness and providing remote monitoring. The device functions as an optional metered dispensing tool for specific prescribed medications where the provider determines, and the patient and/or authorized caregiver concurs, that the patient and treatment plan will benefit from the controlled access and intended user authenticated remote monitoring capabilities that the COPA offers.
"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 that bridges the gap between self-managed and professionally managed dispensing is urgently needed," stated John Timberlake, Chief Executive Officer of Berkshire. "Of the 5.7 million people in the U.S. with Opioid Use Disorder, only 18% receive medication treatment. The daily requirement to travel to an Opioid Treatment Program (OTP) clinic has been shown to reduce treatment retention and deter other patients from starting treatment at all. We believe COPA has the potential to dramatically expand methadone take-home medication treatment for OUD which could not only increase patient treatment retention but may also significantly increase the number of people seeking OUD treatment."
As previously announced, Berkshire Biomedical recently received its second Fast-Track Small Business Innovation Research (SBIR) grant from the National Institutes of Health's (NIH) National Institute of Drug Abuse (NIDA).
"The support from NIDA demonstrates the NIH's 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)," added Mr. Timberlake.
About the National Institute on Drug Abuse (NIDA)
NIDA is a component of the National Institutes of Health, U.S. Department of Health and Human Services. NIDA supports most of the world's research on the health aspects of drug use and addiction. The Institute carries out a large variety of programs to inform policy, improve practice, and advance addiction science. For more information about NIDA and its programs, visit www.nida.nih.gov.
About the National Institutes of Health (NIH)
NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
About Berkshire Biomedical Corporation
Berkshire Biomedical Corporation is a privately held medical device company. Berkshire is pioneering the use of biometric technologies, combined with encrypted HIPAA compliant cloud-based and healthcare provider-enabled remote management systems, to provide precise and accurate personalized medication delivery to only the Authenticated Intended User (AIU).
The Company's lead product under development, the Computerized Oral Prescription Administration System (COPA), is a hand-held, automated, personalized oral liquid dispensing system designed and intended to deliver controlled and non-controlled liquid oral medications to only the AIU upon confirmation of dual biometric identification (fingerprint and dentition).
Upon receiving regulatory authorization, the Company intends to initially seek opportunities to leverage COPA in the delivery and remote management of oral liquid medication methadone, for Medication Use for Opioid Use Disorder treatment and subsequently for the delivery of controlled medications for the treatment of pain, as those patients have the greatest need for the benefits of COPA's features.
In addition, the Company will look to expand COPA use in broader drug therapeutic categories, clinical applications, and businesses that manage the commercialization and data analytics provided by electronic devices to improve outcomes and reduce risk.
Additional information about Berkshire Biomedical and the COPA System can be found at www.berkbiomed.com. The COPA™ System has not received marketing authorization from the U.S. Food and Drug Administration and is not available for commercial sale.
Disclaimer: Research reported in this publication was supported by the National Institute on Drug Abuse of the National Institutes of Health under Award Numbers R44DA057185 and R44DA061908-01A1. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
CONTACT:
Berkshire Biomedical Corporation
BD@berkbiomed.com
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Rx Communications Group, LLC
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