Sandoz and Pear Therapeutics rolled out an FDA-cleared prescription digital treatment for substance use disorders. Called reSET, it secured FDA authorization last year on the strength of clinical data linking the cognitive behavioral therapy it provides to improved abstinence rates in people with SUD.
Novartis’ Sandoz will lead the launch under the the terms of its agreement with Pear, which will provide a patient services hub to support the rollout.
It is now 14 months since approval, Pear raised $50 million to fund the commercialization, before deciding to pass responsibility for the introduction onto Sandoz.
Approved in 2017, the FDA at the time called it the first mobile medical app to treat substance use disorders. It's intended for use alongside treatment by a doctor.
Sandoz starts the commercialization process armed with data from a clinical trial of 399 people with SUDs related to alcohol, cocaine, marijuana and stimulants. Around half of the participants were offered group or individual therapy sessions at least twice a week. Results from this control arm were compared to a cohort that received access to reSET and a reduced face-to-face therapy program.
The goal was to show that the therapy lessons provided via reSET would help people learn to identify triggers that increase their risk of relapse, find ways to cope with thoughts about substance use and otherwise develop strategies to maintain abstinence. These lessons and associated rewards, which collectively form the community reinforcement approach, can be conveyed face to face. What reSET seeks to do is make the approach standardized and scalable, thereby increasing access.
Two-fifths of participants who used reSET were abstinent nine to 12 weeks into the trial, compared to 18% of control subjects in Pear's clinical trial. That resulted in the trial hitting its primary endpoint.
Even with the new technology, getting individuals off of substances is a steep challenge. Both reSET and standard of care treatments were far more successful at helping individuals maintain abstinence than actually getting people to stop using a substance. Ninety percent of people in the reSET arm who were using a substance at the start of the trial were still using it at the end. But the proportion of people in the control group who stopped using a substance during the study was lower still.
The novelty of the technology and level of interest in digital therapeutics — which has also attracted investments from Sanofi and others — will ensure the introduction is closely watched. The success, or otherwise, of the commercialization will provide an early indication of whether companies can easily translate promising clinical data on digital therapeutics into widely-used commercial products.