Berkshire Biomedical Corporation (“Berkshire” or “the Company”), focused on developing its proprietary, hand-held, automated personalized drug dispensing technology to enhance patient wellness, today announced that it has been awarded the first phase of a two-phase Fast-Track Small Business Innovation Research (SBIR) grant (1R44DA057185-01) from the National Institutes of Health’s (NIH) National Institute of Drug Abuse (NIDA).
Valued at approximately $2.0 million over two years, the two-phase grant will support continued non-clinical development of the Company’s Computerized Oral Prescription Administration System (COPA™) for at home methadone administration as part of Medication for Opioid User Disorder (MOUD) treatment.
COPA is a novel oral liquid dispensing system with remote monitoring and advanced analytics specifically designed to deliver accurate and precise doses of controlled and non-controlled prescription medications to only a biometrically authenticated Intended User. Berkshire has been awarded Phase I funds of approximately $266,000. Receipt of the approximate $1.7 million Phase II award will be contingent on an assessment of the Phase I report, the review and approval of any other documentation necessary for continuation, and availability of funds.
“The Fast-Track SBIR grant process is highly competitive, with only 15% of applicants having been chosen under this program in 2021. 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,” stated John Timberlake, Chief Executive Officer of Berkshire.
Mr. Timberlake continued, “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).”