Prescription Digital Therapeutic Approved for Opioid Use Disorder
The medical app is meant to increase retention of patients with OUD in outpatient treatment.
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.
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.
For more information call (833) 697-3738 or visit PearTherapeutics.com.