Sandoz and Pear Therapeutics announced that the Food and Drug Administration (FDA) has granted clearance for reSET-O, the first prescription digital therapeutic for patients with opioid use disorder (OUD). 

reSET-O is intended for use as an adjunct to outpatient treatment that includes transmucosal buprenorphine (medication-assisted-treatment [MAT]) and contingency management for patients aged ≥18 years who are currently under clinician supervision. The medical app is meant to increase retention of patients with OUD in outpatient treatment by providing cognitive behavioral therapy (CBT).

reSET-O is a 12-week (84-day) interval digital therapeutic that delivers Community Reinforcement Approach (CRA) therapy through a series of interactive lessons. Each lesson contains a CBT component and skill-building exercises through audio, text, video, animations, and graphics. Through reSET-O, patients can self-report cravings and triggers as well as use or non-use of buprenorphine. 

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A clinical trial (N=170), sponsored by the National Institute on Drug Abuse, evaluated reSET-O in patients with OUD over 12 weeks. Eligible patients were randomized to treatment-as-usual (TAU) or reSET-O with standard clinician interactions in conjunction with buprenorphine. Results showed a statistically significant increase in retention for patients who used reSET-O vs those who did not (overall retention rate through 12 weeks: 82.4% vs 68.4%)

The prescription-only reSET-O application is anticipated to launch in the coming days. It is not intended for use as a stand-alone therapy, as a substitute for medication, or for patients whose primary language is not English. 

Recently, Sandoz and Pear Therapeutics announced the availability of reSET, a digital therapeutic for patients with substance use disorder

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