The Food and Drug Administration (FDA) has approved a new prescription digital therapeutic (PDT) for people with Opioid Use Disorder (OUD). reSET-O is immediately available and is another effort to help curb the effects of the nation’s opioid epidemic.
Sandoz Inc., a division of Novartis, and Pear Therapeutics Inc., are jointly launching reSET-O, a 12-week cognitive behavioral therapy intended as an outpatient therapy for patients addicted to opioids but trying to stay clean. reSET-O includes a transmucosal buprenorphine, a commonly used medication to treat opioid addiction, as well as contingency management that provides incentives to reinforce behaviors.
Once reSET-O is prescribed, the patient is contacted by a patient care specialist and provided with an access code. This allows the patient to download and install reSET-O on their smartphone or tablet. The code allows the patient to unlock their treatment program.
By using the program, the patient can complete lessons, answer quizzes, report medication usage and substance use, cravings or triggers. The patient also attends therapy sessions with a clinician who can monitor the patient’s reSET-O progress through a dashboard.
“Addiction is a chronic and relapsing disease that requires constant support, monitoring and access to treatment,” said Corey McCann, M.D., Ph.D, President and CEO of Pear Therapeutics. “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.”
reSET-O was approved by the FDA based on clinical trial data that showed the program had an overall retention rate of 82.4 percent through the end of 12 weeks of treatment compared with 68.4 percent overall retention patients who did not use reSET-O.