FDA Clears Mobile Medical Application for Patients with Opioid Use Disorder

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On December 10, 2018, the U.S. Food and Drug Administration (FDA) announced that it granted clearance of the reSET-O™, a mobile medical application to help increase retention of patients with Opioid Use Disorder (OUD) in an outpatient treatment.

Developed under an agreement between Pear Therapeutics and Sandoz Inc., a division of Novartis, reSET-O™ is said to be the first FDA-cleared Prescription Digital Therapeutic (PDT) for patients with Opioid Use Disorder.  It is a mobile device application that provides a 12-week interval PDT for patients with OUD. Utilizing Community Reinforcement Approach (CRA), reSET-O™ provides a series of training, monitoring, and reminder tools and/or lessons for patients and health care providers alike.  A clinical trial sponsored by National Institute of Drug Abuse (NIDA) found statistically significant increase in patient retention in a treatment program for 12 weeks who used the reSET-O™ program.

President and CEO of Pear Therapeutics, Corey McCann, M.D., Ph.D, reiterated the importance of the FDA clearance of the reSET-O™ for treating patients with OUD.

Nearly 50,000 drug overdose deaths involving opioids . . . took placed in the U.S. in 2017. Thereis an urgent need for new and innovative therapeutics to address this public health epidemic. This groundbreaking decision by the FDA ushers in a new standard for treating patients with Opioid Use Disorder and it signals a new path for therapeutic software to be used in conjunction with pharmacotherapy to improve efficacy.

FDA Commissioner Scott Gottlieb, M.D. addressed the FDA’s continued commitment to promote the development of medical device that could help treat addiction:

As part of our efforts to address the misuse and abuse of opioids, we’re especially focused on new tools and therapies that can help more people with opioid use disorder successfully treat their addition. Medical devices, including digital health devices like mobile medical apps, have the potential to play a unique and important role in contributing to these treatment efforts.

Sandoz, per the terms of the agreement, has already launched reSET®, Pear’s PDT for the treatment of Substance Use Disorder, in November 2018 and plans to launch reSET-O™ soon.

 

 

Sean Kim
Sean S. Kim is an associate in the firm's Orange County office. He practices intellectual property law with an emphasis on patent prosecution, due diligence, and portfolio management in the mechanical and medical device practice areas. Sean received his Bachelor's Degree in General Engineering from Harvey Mudd College and attended University of Illinois College of Law. During law school, Sean served as president of Asian American Law Students Association and as a production editor of Journal of Law, Technology & Policy. Prior to law school, he worked for a start-up company that designed and manufactured fuel cells and wafer manufacturing equipment company.
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