MedicaSafe has joined forces with Amneal Pharmaceuticals to provide the latter’s generic version of Suboxone (buprenorphine and naloxone) as part of its data-generating medication system.
The collaboration is aimed at offering a system to generate real-time data of the patient’s medication access pattern, produce actionable information for clinicians treating opioid use disorder (OUD).
MedicaSafe chief executive officer Matt Ervin said: “The MedicaSafe system enables dose-by-dose tracking of medication access. Our research with generic Suboxone indicates that providing clinicians with detailed data on medication access can allow them to adjust treatments in a targeted and timely manner.”
Speciality pharmacies will handle the setup and distribution of MedicaSafe SmartKey
According to the National Institute on Drug Abuse (NIDA), more than 2.5 million people in the US suffer from OUD, and Buprenorphine marks the only opioid substitute approved by the FDA for OUD treatment.
Under the collaboration, Amneal offers generic Suboxone in pre-packaged, disposable, secure and tamper-evident MedicaSafe cartridges, through a separate companion device, the MedicaSafe SmartKey, to dispense an authorised dose from the cartridge.
The SmartKey validates the user, considering factors including the prescribed regimen and recent medication access before dispensing.
The system allows prescribers to specify the dose access algorithm through a standard written prescription, and they can rule out tampering by asking patients to bring cartridges to each office visit.
The data of Dose dispensation can be further validated by lab tests to confirm whether the doses were ingested. The setup and distribution of MedicaSafe SmartKey are handled by speciality pharmacies.
The MedicaSafe SmartKey records details of each dispensation and transfers data to a cloud portal for prescriber review, and the reports generated through MedicaSafe SmartKey data would underline aberrant patterns for a single individual and across a patient population.
Amneal Pharmaceuticals co-CEO Chirag Patel said: “We are happy to partner with the MedicaSafe team as they bring data-generating medication systems to market. Clinicians dealing with opioid misuse desire new treatment approaches, and we hope a complete system like this can help prescribers treat OUD and promote successful compliance.”
