Sandoz Inc. and Pear Therapeutics Obtain FDA Clearance for reSET-O(TM) to Treat Opioid Use Disorder

Novartis International AG / Sandoz Inc. and Pear Therapeutics Obtain FDA Clearance for reSET-O(TM) to Treat Opioid Use Disorder . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement.

• reSET-O^TM is the first FDA-cleared Prescription Digital Therapeutic (PDT) for patients with Opioid Use Disorder

Pear Therapeutics is leading the development of a new therapeutic class with two FDA-authorized PDTs and a robust pipeline of therapeutics across disease areas

Sandoz will lead U.S. commercial launch, anticipated in coming days in Q4

As part of broader Novartis digital revolution, Sandoz aims to increase patient engagement and improve access to treatment through digital solutions

HOLZKIRCHEN, December 10, 2018 - Sandoz Inc., a division of Novartis, and Pear Therapeutics, Inc., the leader in prescription digital therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted clearance for reSET-O^TM. 

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 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.