First FDA-cleared 'digital therapeutic' for opioid use disorder debuts

Pear Therapeutics and Sandoz, a division of pharmaceutical company Novartis, launched reSET-O, a digital therapeutic for opioid use disorder, Jan. 7.

The FDA cleared reSET-O in December, making it the first authorized app to aid in the treatment of opioid use disorder. The prescription-only app delivers 12 weeks of cognitive behavioral therapy to patients enrolled in outpatient treatment to help increase skills retention. The program also includes transmucosal buprenorphine, a medication used to treat opioid addiction.

The app encourages patients to report information on medication adherence, cravings and triggers, which reSET-O presents to clinicians through a data dashboard.

"Addiction is a chronic and relapsing disease that requires constant support, monitoring and access to treatment," said Corey McCann, MD, PhD, president and CEO of Pear Therapeutics. "We believe prescription digital therapeutics can transform the way clinicians treat addiction by providing a way for patients to access treatment when and where it's needed."

The product launch builds on another digital therapeutic, reSET, which Pear Therapeutics and Sandoz debuted in November. ReSET was the first FDA-cleared app to aid in the treatment of alcohol, cocaine and stimulant substance use disorders.

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