The FDA has cleared its first prescription digital therapeutic for patients suffering from opioid abuse: a smartphone app designed by Pear Therapeutics to be used alongside standard-of-care medication-assisted treatments.

Commercialization of the reSET-O app will be led by Novartis’ Sandoz unit and is expected to launch by the end of the year. Sandoz and Pear inked a profit-splitting deal this past April for both reSET-O and the earlier reSET app, which received FDA approval in September 2017 for substance use disorder.

The new app aims to help adult patients adhere to outpatient treatment over 12 weeks, including with transmucosal buprenorphine film, by providing interactive therapy lessons that challenge harmful behaviors, help develop coping strategies and reinforce the importance of taking medication.

ReSET-O also supports communication between visits, allowing patients to self-report cravings and triggers to their physician, and their buprenorphine use.

"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 addiction," FDA Commissioner Scott Gottlieb said in an agency statement. "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."

"We know medication-assisted treatment works and we support novel ways to keep individuals more engaged in their treatment programs and to provide clinicians with new ways to intervene to help them remain in treatment," Gottlieb added.

According to national surveys by the U.S. Substance Abuse and Mental Health Services Administration, over 80% of patients do not receive or seek out care for opioid abuse, and only 13% of outpatient facilities offer treatment medications such as buprenorphine. Pear and Novartis believe reSET-O could cut down that treatment gap as part of a multimodal therapy, as well as help standardize care in across different locations.

"Nearly 50,000 drug overdose deaths involving opioids, including prescription pain medications and heroin, took place in the U.S. in 2017," said Pear President and CEO Corey McCann. "There is an urgent need for new and innovative therapeutics to address this public health epidemic."

ReSET-O was evaluated in a clinical trial sponsored by the NIH’s National Institute on Drug Abuse, which saw significant improvements in retention in the 170 patients randomized to either the standard buprenorphine treatment or its combination with the app.

"Digital technologies and data science have incredible potential to unlock the next chapter of medical innovation and to help individuals finally take control of their own health in a meaningful way," said Sandoz CEO Richard Francis. "New digital therapeutics such as reSET-O also have the potential to fundamentally change how patients interact with their therapies and thus improve patient outcomes."

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