The National Institutes of Health (NIH) has awarded Berkshire Biomedical Awarded $266,000 to support continued development of an automated, at-home methadone administration system.
Called the COPA system, the proprietary, hand-held drug dispensing device is meant to provide at-home methadone administration as part of treatment for opioid use disorder (OUD). The system delivers the liquid methadone, and includes remote monitoring to make sure precise doses of medication are delivered.
The $266,000 is for Phase I of the development of the system; Phase II would be for $1.7 million and would be contingent upon the assessment of Phase I, according to a Berkshire Biomedical July 25 announcement of the award.
Dallas-based Berkshire Biomedical said that the drug dispensing technology award is part of a Fast Track Small Business Innovation Research (SBIR) grant from the NIH’s National Institute on Drug Abuse (NIDA).
There has been great interest in monitoring self-administration of methadone, along with the increase in take-home medication from opioid treatment programs (OTPs) which came as part of COVID-19 rules set in March 2020 to minimize patient contact in clinics. Those increased take-homes are increasingly popular among patients.
The cost of the device to OTPs or insurance companies or states or the federal government, if it is implemented, is not clear. Also unclear is whether this fee would come out of the costs now going to OTPs for dispensing the medication onsite. However, making it possible for more patients to access methadone, especially during an overdose epidemic, has clear benefits.
However, at-home drug dispensing devices, whether for methadone or other medications, are a sign that there is more interest in “medication-only” approaches to treatment, something that treatment providers are cautious about. Providers have been able to gauge which patients are stable enough for take-homes, and also to trust the patients and earn trust in return. A monitored device is telegraphing lack of trust. Comprehensive treatment, including care for the patient’s other life and medical problems, are key to the success of OTPs and treatment with methadone, especially in the early stages.
Still, there is great interest in this type of product, even by OTPs, providing that they will still be involved in which patients qualify.
The company is touting the NIDA award as proof of federal support for the concept. “Berkshire’s receipt of this award reflects 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) by dramatically increasing the number of persons being allowed to utilize take home therapy,” said John Timberlake, Chief Executive Officer of Berkshire.
“Prior to the COVID-19 epidemic, there was a serious unmet need to support OUD patients. Now there is an even greater critical need for a system capable of accurately and securely dispensing methadone for at home use that incorporates real-time remote monitoring, as the pandemic has limited access to methadone maintenance treatment (MMT) programs in both urban and rural sections of the U.S. That said, with assistance from this initial Phase I SBIR grant and the subsequent Phase II award, our goal is to complete the development of our enhancements to COPA, complete all necessary device, system, and human factors testing, followed by the subsequent submission of our De Novo request for review by the U.S. Food and Drug Administration (FDA).”
COPA stands for Computerized Oral Prescription and is Berkshire’s lead product under development. The COPA system has not been reviewed by the U.S. Food and Drug Administration and is not available for commercial sale.
For more information, go to www.berkbiomed.com.