NEW YORK--(BUSINESS WIRE)--MedicaSafe Inc., a pioneer of drug-device combination products for high-risk medication management, has received a $1.0 million Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH). The funding will support a clinical trial to examine the effect of MedicaSafe’s drug-device combination system versus standard of care in the treatment management of opioid use disorder (OUD).
According to the U.S. Department of Health and Human Services (HHS), more than 130 Americans die every day from an opioid overdose in the United States. The opioid epidemic is a public health emergency, with more than one million people suffering from addiction who do not have access to treatment. Buprenorphine is the only opioid substitute approved for office-based treatment of OUD, but accidental and sometimes purposeful misuse of the drug contributes to decreased treatment success rates among patients with lower compliance.
MedicaSafe’s first product, funded by the NIH, was developed to help improve medication-assisted treatment via a novel and “smart” drug-device technology. The system is comprised of secure pre-packaged buprenorphine/naloxone cartridges, and each dose is designed to be dispensed by a SmartKey device. The SmartKey is programmed by certified pharmacies with a treatment plan that allows for dispensation of the right dose at the right time. Each dose dispensation, or the lack thereof, is recorded and collated into treatment reports that enable clinicians to track patient adherence to their regimen.
“This NIH grant reflects the support of key opinion leaders for our patented approach to improving management of high-risk medications via technology,” said Matt Ervin, founder and CEO of MedicaSafe. “What makes MedicaSafe unique is our ability to generate real-time data that provides insights into patient behavior, which enables earlier intervention when necessary and promotes improved compliance and outcomes.”
MedicaSafe’s trial is being conducted to determine whether the system can help foster treatment compliance and assist clinicians. The system is currently being studied for design validation and will undergo a randomized controlled trial that will aim to take patients from induction to stable maintenance in office-based buprenorphine treatment.
“The Substance Abuse and Mental Health Services Administration estimates that 12 million Americans misuse prescription opioids for non-medical purposes annually. There is an urgent need for innovative approaches that enhance and expand treatment to those with opioid use disorder,” said Anand Mattai, M.D., Chief Medical Officer at MedicaSafe and project leader of the study. “While the efficacy of buprenorphine/naloxone is proven, the effectiveness of the drug is significantly diminished by poor compliance. We set out to change this by bolstering support of the drug with innovative technology that is intended to improve risk stratification, daily compliance and drug safety.”
About MedicaSafe Inc.
MedicaSafe is the first and only company developing drug-device combination products that produce information about medication access in real time. The company is at the forefront of data-generating medication systems designed to improve clinical insight and promote patient compliance. The company’s first product, funded by the National Institutes of Health, combines buprenorphine/naloxone with novel technology to target opioid use disorder. As poor compliance to this medication is associated with relapse, MedicaSafe’s approach aims to facilitate earlier, potentially life-saving interventions when necessary. Learn more at www.medicasafe.com.