October 03, 2019

MedicaSafe Announces Partnership with Amneal Pharmaceuticals

NEW YORK--(BUSINESS WIRE)--MedicaSafe, Inc. today 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.”

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August 01, 2019

MedicaSafe Appoints Esther Dyson and Dr. Andrew Saxon to Advisory Board

NEW YORK--(BUSINESS WIRE)--MedicaSafe, Inc., a pioneer of high-risk medication management systems, named Esther Dyson and Dr. Andrew Saxon as members of its Advisory Board. Highly respected industry thought leaders focused on improving health outcomes, Ms. Dyson and Dr. Saxon will provide invaluable strategic counsel as MedicaSafe accelerates clinical development of its high-risk medication management system for opioid use disorder (OUD). Ms. Dyson is also an investor in the company.

“What fascinates me most as an investor and entrepreneur is how we can best use technology to improve the health of Americans. MedicaSafe has taken a fresh, data-rich approach to the opioid epidemic by looking at how technology can better improve the management of high-risk medications that studies show work, but are plagued by poor compliance,” said Ms. Dyson. “Joining the MedicaSafe Advisory Board is a great opportunity to truly transform the delivery of healthcare.”

Ms. Dyson has extensive expertise in analyzing the effects of emerging technologies and markets on economies and societies. She serves as an investor and board member of space exploration, health and technology start-ups and currently serves as executive founder of Way to Wellville, a 10-year nonprofit project dedicated to demonstrating the value of investing in health.

“Treatment for opioid use disorder with buprenorphine/naloxone along with behavioral therapies is only effective when supported with proper daily compliance, and this is why the technology that MedicaSafe has developed is so important,” said Dr. Saxon. “By providing clinicians with dose-by-dose dispensation data and control over when medication can be accessed, they have the ability to potentially alter the decision-making process and facilitate earlier, potentially life-saving interventions when necessary.”

Dr. Saxon is frequently cited as an industry expert on medication-assisted treatment for opioid use disorder. He currently serves as director of the Addiction Psychiatry Residency Program at the University of Washington in Seattle. Dr. Saxon serves on the editorial boards of the Drug and Alcohol Dependence Journal and the General Hospital Psychiatry Journal and his current research work is supported by the Department of Defense, the National Institute on Drug Abuse and the Veterans Administration.

“Esther and Andrew’s backgrounds in healthcare and technology are renowned. Their addition to our Advisory Board comes at an ideal time as we make significant progress in our new approach to managing high-risk medications,” said Matt Ervin, founder and CEO of MedicaSafe. “Both have already made tremendous contributions to the company and we are grateful for their partnership in shaping the future of healthcare.”

The rampant misuse of and addiction to opioids is a serious national crisis that impacts public health and social and economic welfare. Opioids caused approximately 48,000 deaths last year and the total economic burden of prescription opioid misuse is more than $78 billion a year, including the costs of healthcare, lost productivity, addiction treatment and criminal justice involvement.i While effective treatment of OUD has been demonstrated with buprenorphine/naloxone (B/N) in combination with behavioral therapies, patient compliance is predictive of both relapse and treatment retention. Studies have shown that patients who are noncompliant with OUD treatment in the first three months of treatment are 10 times more likely to relapse than those who are compliant.

Funded by the National Institutes of Health (NIH), the MedicaSafe system produces detailed data on patient behavior with treatment medications. The system is built around pre-packaged buprenorphine/naloxone cartridges that are secure and tamper-evident. 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. MedicaSafe provides only the daily dose of medication specified by the prescription, and locks if the patient tries to take extra pills. Each dose dispensation, or the lack thereof, is recorded and collated into treatment reports that enable clinicians to track patient adherence.

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July 09, 2019

MedicaSafe Receives $1.0 million Grant from National Institutes of Health

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.”

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