First FDA-cleared 'digital therapeutic' for substance use disorder launches

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Pear Therapeutics and Novartis division Sandoz launched reSET, a digital therapeutic for substance use disorder, Nov. 19.

The FDA cleared reSET in September 2017, making it the first authorized app to aid in the treatment of alcohol, cocaine and stimulant substance use disorders. The prescription-only app delivers 12 weeks of interactive cognitive behavioral therapy to patients enrolled in outpatient treatment, in an effort to increase skills retention.

The app also encourages patients to report information on substance use, cravings and triggers, which reSET presents to clinicians through a data dashboard.

"This is an example of how innovative digital technologies can help provide patients access to additional tools during their treatment," Carlos Peña, PhD, director of the division of neurological and physical medicine devices in the FDA's Center for Devices and Radiological Health, said after the agency cleared the app in 2017.

"More therapy tools means a greater potential to help improve outcomes, including abstinence, for patients with substance use disorder," he continued.

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