Novartis (NYSE:NVS) division Sandoz and Pear Therapeutics this week kicked off the U.S. commercial launch of the first FDA-cleared prescription digital therapy for people with opioid use disorder.
The companies partnered to commercialize a 12-week cognitive behavioral therapy intended to be used in tandem with outpatient treatment. The therapy includes transmucosal buprenorphine and contingency management designed to reinforce positive behaviors, the companies reported.
In a pivotal trial of 170 patients, the reSET-O therapy had an overall retention rate of 82.4% through the end of 12 weeks, compared to an overall retention rate of 68.4% for people who did not use reSET-O.
According to the terms of the commercial deal that Sandoz and Pear inked in April last year, Sandoz will take the lead on marketing and commercializing Pear’s prescription digital therapeutics.
“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,” Sandoz CEO Richard Francis said in prepared remarks. “At Sandoz, we are proud and excited to push the frontiers of medical innovation.”
“Addiction is a chronic and relapsing disease that requires constant support, monitoring and access to treatment,” Dr. Corey McCann, president & CEO of Pear Therapeutics, added. “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.”
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