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17 Dec 2018

Novartis app for opium addicts gets US approval

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Sandoz Inc., a division of Swiss pharmaceutical giant Novartis, and US company Pear Therapeutics announced this week that the the U.S. Food and Drug Administration (FDA) has approved an app that can be prescribed to help treat opium addicts.

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 a digital therapist, the app is intended to protect patients from relapses with interactive dialogues.  Every day, approximately 115 Americans die after overdosing on opioids.

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

Under the terms of a commercial deal, 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.

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.

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