Treating Opioid Use Disorder: Sandoz and Pear Therapeutics’ Mobile App Approved by FDA

Update (January 10, 2019): 

Pear Therapeutics successfully raised $64 million to support the global commercialization of its reSET mobile app products. As of January 7, 2019, Sandoz and Pear Therapeutics’ reSET-O was made commercially available for patients with opioid use disorder.

Originally published on December 17. 2018: 

The opioid crisis made headlines last year when President Donald Trump declared it a national health emergency. According to a 2015 survey by the US Department of Health and Human Services, at least 2 million people have an opioid use disorder.

The DSM-V defines opioid use disorder as a “problematic pattern of opioid use leading to clinically significant impairment or distress.” Among the diagnostic criteria are a persistent desire or unsuccessful efforts to control opioid use and having a strong urge to use opioids. Opioid use disorder is also associated with an increased risk for suicide attempts and completed suicides.

There is no perfect way to cure someone of opioid use disorder. But a historic FDA approval last week suggests that digital therapeutics might steer us in the right direction.

The mobile medication app, reSET-O, uses cognitive behavioral therapy techniques to motivate patients to stay in an opioid use disorder outpatient program. The team at Pear Therapeutics successfully launched its predecessor, reSET, for the treatment of substance use disorder. reSET was approved by the US FDA in 2017.

Sandoz, a division of Novartis Group, has partnered with Pear Therapeutics to market and commercialize reSET-O.

“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 Richard Francis, Chief Executive Officer of Sandoz. “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. At Sandoz, we are proud to be a joint pioneer in this exciting new field.”

Some features of the app include skill-building exercises, therapy lessons through text or audio, as well as incentives and awards for abstinence. Currently, reSET-O is recommended as an adjunct to buprenorphine treatment and contingency management (CM), a behavior modification intervention.

The approval comes after promising results of a desktop version of the app were published in the Journal of Consulting and Clinical Psychology. One hundred and seventy participants were randomly assigned to receive 12 weeks of CM and buprenorphine or CM, plus access to web-based modules grounded in a Community Reinforcement Approach (CRA). The researchers found that greater numbers of participants who completed web training stayed in treatment and abstained from drug taking for a greater number of days compared to participants in CM.

Such promising evidence suggests a mobile application, that can be easily downloaded to a patient’s phone, might be even more effective.

“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. 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,” said FDA commissioner Dr. Scott Gottlieb, in a press release regarding last Monday’s approval.

Indeed, Dr. Gottlieb launched an innovation challenge in April to directly combat the opioid crisis with medical device-based approaches. Applicants selected for the challenge boasted products that aid drug monitoring, pain therapy, diagnosis and more.