One of MedicaSafe’s primary goals is to develop products for high-risk medication management. So it makes sense for the New York-based company to focus on opioid addiction, which claims the lives of more than 130 people every day in the U.S. (According to the U.S. Department of Health and Human Services).
The New York-based company recently received $1 million Small Business Innovation Research grant from the National Institute of Health, with a specific focus on opioid use disorder (OUD).
The funding will support a clinical trial to examine the effect of MedicaSafe’s drug-device combination vs. standard of care in the treatment management of OUD. The trial is conducted to determine whether the system can help foster treatment compliance and assist clinicians.
“What we’re trying to do is create data-generating medications,” Matt Ervin, founder, and MedicaSafe CEO, told MD+DI. “The how is by marrying medications with new technology in a manner that facilitates this data generating process.”
MedicaSafe’s 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.
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.
“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,” Anand Mattai, MD, CMO at MedicaSafe and project leader of the study, said in a release. “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.”
Ervin pointed out some of the issues clinicians would run into when it comes to getting out in front of OUD.
“There’s a lack of information the prescriber has about what the patient is doing,” Ervin said. “There are a lot of things the patient could be doing when they’re going through treatment for opioid use disorder. They could be intermittently compliant to the medication. It could be very difficult for the prescriber to know that. The only real objective tool the prescriber has right now is lab testing. And that generally happens when the patient comes back to the doctors. They sort of know in advance when it’s going to happen. It only detects what’s in that patient from 48 to 72 hours prior to that test.”
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.
Ervin noted that OUD is just the tip of the iceberg and that the company was working on many other medications and disease states.