Sandoz Inc., a Novartis division, and Pear Therapeutics has announced the US commercial launch of reSET-O(TM) for patients with Opioid Use Disorder (OUD).

reSET-O was cleared by the US Food and Drug Administration (FDA) in December. The reSET-O prescription digital therapeutic (PDT) is a 12-week cognitive behavioral therapy intended to be used in addition to outpatient treatment.

It includes transmucosal buprenorphine, a commonly used medication to treat opioid addiction, and contingency management designed to provide incentives to reinforce positive behaviors. reSET-O is available by prescription only for patients 18 years or older under the care of a clinician.

Richard Francis, CEO, Sandoz said, "The launch of reSET-O provides an important technology-based treatment option for patients with Opioid Use Disorder and may fundamentally change how they interact with their therapies.”

Corey McCann, President and CEO of Pear Therapeutics said, “Addiction is a chronic and relapsing disease that requires constant support, monitoring and access to treatment. We believe prescription digital therapeutics can transform the way clinicians treat addiction by providing a way for patients to access treatment when and where it's needed. reSET-O has been clinically proven to increase the likelihood that a patient will remain in treatment, while also providing a way for patients to access treatment anytime, anywhere, under clinician supervision."

When a healthcare provider prescribes reSET-O, the patient is contacted by a patient care specialist and is provided with an access code. The patient then downloads and installs reSET-O on their smartphone or tablet and enters the access code to unlock treatment.

After that, the patient can begin working and learning with reSET-O by completing lessons, answering quiz questions, reporting medication usage and reporting substance use, cravings and triggers. All the while, the patient continues to see the clinician in therapy sessions and progress on reSET-O is tracked via the Clinician Dashboard.

Under the terms of a commercial deal announced in April 2018, Sandoz will lead marketing and commercialization of reSET-O and reSET®, Pear's prescription digital therapeutics for the treatment of Substance Use Disorder and Opioid Use Disorder, respectively. Sandoz launched reSET in November 2018 and now has made reSET-O available to patients in the U.S.

The reSET-O(TM) 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.