FDA approves prescription digital therapeutic, reSET-O for patients with opioid use disorder. Sandoz.

Sandoz Inc., a division of Novartis, and Pear Therapeutics, Inc., the leader in prescription digital therapeutics, announced that the FDA has granted clearance for reSET-O. reSET-O is intended to increase retention of patients with Opioid Use Disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy (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. "Digital technologies and data science have incredible potential to unlock the next chapter of medical innovation and to help individuals finally take control of their own health in a meaningful way," said Richard Francis, CEO, Sandoz. "New digital therapeutics such as reSET-O also have the potential to fundamentally change how patients interact with their therapies and thus improve patient outcomes. At Sandoz, we are proud to be a joint pioneer in this exciting new field."

Under 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 Prescription Digital Therapeutic (PDT) for OUD.

reSET-O is modeled on the Community Reinforcement Approach (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. reSET-O is intended as an adjunct to standard of care for patients with OUD. It is limited to persons with a valid prescription from their licensed provider. reSET-O supports clinician-patient communication between visits, by providing a means for patients to self-report cravings and triggers, and buprenorphine use/non-use. reSET-O reinforces the importance of using buprenorphine for treatment of OUD.