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

  • ReSET-OTM 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-OTM

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.

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. 

"Nearly 50,000 drug overdose deaths involving opioids, including prescription pain medications and heroin, took place in the U.S. in 2017," said Corey McCann, M.D., Ph.D., President and CEO of Pear Therapeutics. "There is an urgent need for new and innovative therapeutics to address this public health epidemic. This groundbreaking decision by the FDA ushers in a new standard for treating patients with Opioid Use Disorder and it signals a new path for therapeutic software to be used in conjunction with pharmacotherapy to improve efficacy."

More than 80 percent of patients with OUD do not receive or seek out care[i] and only 13 percent of outpatient facilities in the U.S. offer MAT, such as buprenorphine[ii]. reSET-O could have the potential to dramatically impact this gap in treatment, by delivering multi-modal therapy in combination with MAT in a way that is designed to be more effective, convenient, and easy to access for patients and clinicians. reSET-O helps to offer standardized and enhanced care for OUD, providing particular benefit in geographies where access to care is currently inconsistent or unavailable.

To support the FDA submission of reSET-O, a National Institute on Drug Abuse-sponsored clinical trial evaluated the therapeutic in 170 patients with OUD over 12 weeks. Patients were randomized to receive either treatment-as-usual (TAU), which consisted of standard clinician interactions in conjunction with buprenorphine, or reSET-O with standard clinician interactions in conjunction with buprenorphine. At the end of the study, patients randomized to reSET-O CBT, when used with outpatient treatment and contingency management, significantly improved retention among patients with buprenorphine plus contingency management treatment experience[iii]. Treatment dropout during the 12-week intervention was reduced in the test group compared to the TAU group. This reduction in treatment dropout was significant.

High attrition and relapse rates represent a significant problem to providing care to patients with OUD. Therefore, it is important to retain patients in treatment. Retention in treatment is a well-established indicator of successful treatment outcomes for OUD patients[iv]. The finding that reSET-O significantly improved patient retention rates supports the efficacy of reSET-O in increasing retention of patients with OUD in outpatient treatment.

About Opioid Use Disorder
Every day, approximately 115 Americans die after overdosing on opioids[v]. The misuse of and addiction to opioids-including prescription pain relievers, heroin, and synthetic opioids-is a serious national crisis that affects public health as well as social and economic welfare. The Centers for Disease Control and Prevention estimates that the total "economic burden" of prescription opioid misuse alone in the United States is $78.5 billion a year, including the costs of healthcare, lost productivity, addiction treatment, and criminal justice involvement.

reSET-OTM Indications for Use
reSET-OTM is intended to increase retention of patients with Opioid Use Disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine 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. 

This Press Release does not include all the information needed to use reSET-O safely and effectively. Please see the Clinician Brief Summary Instructions for reSET-O for more information at Clinician Brief Summary Instructions for reSET-O

About reSET-OTM
The reSET-OTM prescription mobile medical application is a 12-week (84-day) software application. It is limited to persons with a valid prescription from their licensed provider. reSET-O is intended to be used to increase retention of patients with Opioid Use Disorder in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management to patients currently under clinician care.


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