Milestone Marks Critical Step Toward Bringing COPA to Market to Improve Access, Adherence and Outcomes in Opiod Use Disorder and Other Chronic Conditions
Berkshire Biomedical Corporation, focused on developing its proprietary drug dispensing technology to enhance patient wellness, 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).
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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, 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.
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“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.
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Source – PR Newswire
