Amneal Pharmaceuticals LLC issued the following announcement on Oct. 3.
MedicaSafe, Inc. announced a partnership with Amneal Pharmaceuticals, Inc. (NYSE: AMRX) to provide Amneal’s generic version of Suboxone® (buprenorphine and naloxone) as part of MedicaSafe’s data-generating medication system. This partnership provides a system aimed to deliver real-time information about the patient’s medication access pattern, producing actionable information for clinicians treating opioid use disorder (OUD).
More than 2.5 million Americans suffer from OUD according to the National Institute on Drug Abuse (NIDA). Buprenorphine, the active opioid ingredient in Suboxone, is the only opioid substitute approved by the FDA for office-based treatment of OUD. However, studies have shown patients are often non-compliant with buprenorphine medications such as Suboxone and reports of illicit diversion are widespread.1 Poor compliance, whether unintentional or intentional, can reduce treatment success rates. Relapse is harmful to patients and ultimately proves costly to insurance companies and government programs.
“The MedicaSafe system enables dose-by-dose tracking of medication access,” said Matt Ervin, Chief Executive Officer at MedicaSafe. “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.”
Amneal’s generic Suboxone will come pre-packaged in disposable, secure and tamper-evident MedicaSafe cartridges. A separate companion device, the MedicaSafe SmartKey, will be required to dispense an authorized dose from a cartridge. The SmartKey will then authenticate the user and consider factors such as the prescribed regimen and recent medication access before dispensing. Prescribers will be able to specify the dose access algorithm via a standard written prescription, while specialty pharmacies will handle setup and distribution.
The MedicaSafe SmartKey records each dispensation and transfers data to a cloud portal for prescriber review. Reports aim to highlight aberrant patterns for a single individual and across a patient population.
Prescribers can rule out tampering by asking patients to bring cartridges to each office visit. Dose dispensation data can be further corroborated by labs tests to confirm that doses were ingested. These approaches are consistent with current standard of care.
“We are happy to partner with the MedicaSafe team as they bring data-generating medication systems to market,” said Chirag Patel, Co-CEO at Amneal Pharmaceuticals. “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.”
SAFETY INFORMATION, INCLUDING ALL WARNINGS AND PRECAUTIONS, CAN BE FOUND IN THE FULL PRESCRIBING INFORMATION ACCESSIBLE FROM THE LINK BELOW.
About MedicaSafe Inc.
MedicaSafe is at the forefront of smart medication systems designed to improve clinical insight and promote patient compliance, by providing information about medication access in real-time. The company’s first product, funded by the National Institutes of Health, combines buprenorphine and naloxone with novel technology to target the treatment management of 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.
Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is an integrated pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products. The Company has operations in North America, Asia, and Europe, working together to bring high-quality medicines to patients primarily within the United States.
Amneal has an extensive portfolio of more than 300 generic medicines and is expanding its portfolio to include complex dosage forms in a broad range of therapeutic areas. The Company also markets a portfolio of branded pharmaceutical products through its Specialty segment focused principally on central nervous system disorders and parasitic infections. For more information, visit www.amneal.com.
Original source can be found here.