FDA clears Sandoz, Pear Therapeutics' prescription digital therapeutic for opioid use disorder

Novartis' Sandoz unit and Pear Therapeutics announced Monday that the FDA cleared reSET-O, marking the first FDA-cleared prescription digital therapeutic for patients with opioid use disorder. Richard Francis, Sandoz CEO, remarked that digital therapeutics such as reSET-O "have the potential to fundamentally change how patients interact with their therapies and thus improve patient outcomes." Meanwhile, Corey McCann, CEO of Pear Therapeutics, noted that the 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."

According to the companies, the prescription-only mobile medical application is intended to increase retention of patients aged 18 years or older with opioid use disorder in outpatient treatment by providing cognitive behavioural therapy, as an aide to outpatient treatment that includes transmucosal buprenorphine and contingency management. The 12-week interval prescription digital therapeutic delivers community reinforcement approach (CRA) therapy as a series of interactive therapy lessons, the companies added.

The FDA submission of reSET-O was supported by a clinical trial that evaluated the therapeutic in 170 patients with opioid use disorder over 12 weeks. Participants were randomly assigned to either receive treatment-as-usual, consisting of standard clinician interactions in conjunction with buprenorphine, or reSET-O with treatment-as-usual. The results showed that reSET-O significantly improved retention among patients and reduced the treatment dropout during the 12-week intervention.

Under the terms of a commercial agreement announced in April, Sandoz will lead marketing and commercialisation of reSET-O and reSET. The companies launchedreSET last month and said the launch of reSET-O is planned in the US in the coming days.