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Sandoz, Pear Receive FDA Clearance For ReSET-O To Treat Opioid Use Disorder

Sandoz Inc., a division of Novartis (NVS), and Pear Therapeutics Inc. announced that the U.S. Food and Drug Administration has granted clearance for reSET-O.

reSET-O is intended to increase retention of patients with Opioid Use Disorder or OUD in outpatient treatment by providing cognitive behavioral therapy or CBT, as an adjunct to outpatient treatment that includes transmucosal buprenorphine (medication-assisted-treatment, or MAT) and contingency management, for patients 18 years or older who are currently under the supervision of a clinician.

reSET-O is indicated as a prescription-only mobile medical application.

As per the terms of a commercial deal announced in April 2018, Sandoz will lead
marketing and commercialization of reSET-O and reSET, Pear's PDT for the
treatment of Substance Use Disorder. Sandoz launched reSET in November 2018 and
plans to launch reSET-O in the coming days in the U.S.

reSET-O is a 12-week interval PDT for OUD. reSET-O is modeled on the Community Reinforcement Approach or CRA and engineered to deliver CBT for patients with
OUD. reSET-O delivers CRA therapy as a series of interactive therapy lessons.
Each therapy lesson is comprised of a cognitive behavioral therapy component and
skill-building exercises. Therapy lesson content is delivered primarily via text
or audio, and may include videos, animations, and graphics.

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