Novartis division Sandoz and Pear Therapeutics have secured approval from the US Food and Drug Administration (FDA) for the reSET-O mobile medical application to treat opioid use disorder (OUD).
The reSET-O app is a prescription cognitive behavioral therapy, which is intended to enhance retention of patients with OUD in outpatient treatment.
It offers cognitive behavioral therapy (CBT) as an adjunct to outpatient treatment that comprises transmucosal and contingency management for patients 18 years or older who are currently under the supervision of a clinician.
Sandoz CEO Richard Francis said: “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.
“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.”
As part of the commercial agreement signed in April, Sandoz will take responsibility to market and commercialize reSET-O and reSET.
Sandoz has introduced reSET, which is Pear’s prescription digital therapeutic (PDT) to treat OUD, in November this year. The firm intends to launch reSET-O within the short time in the US.
reSET-O is a 12-week interval PDT for OUD, and is developed to deliver CBT for patients with OUD. It is modeled on the community reinforcement approach (CRA) and delivers CRA therapy as a series of interactive therapy lessons.
The FDA submission of reSET-O was supported by a National Institute on Drug Abuse-sponsored clinical trial, which assessed the therapeutic in 170 patients with OUD over 12 weeks.
Patients have been randomized to secure either treatment-as-usual (TAU) that included standard clinician interactions in conjunction with buprenorphine or reSET-O with standard clinician interactions in conjunction with buprenorphine.
Pear Therapeutics president and CEO Dr Corey McCann said: “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.”