FDA approves first medical app, for use in addiction

The FDA has taken a major step in the digitisation of healthcare by handing out the first medical app approval: the reSET app for substance use disorder, created by Pear Therapeutics. The medical app will be used on an outpatient basis to help patients manage their addiction to substances, such as alcohol, cocaine and stimulation substance use disorders (SUDs).

The app would provide cognitive behavioural therapy to patient to improve abstinence from their addictions alongside outpatient addiction therapy and an incentive-based scheme that rewards individuals for avoiding problem substances.

The approval was based on a study involving 399 patients, as part of a 12-week clinical trial. The results found that 40.3% of people using the reSET app were adherent to their treatment programmes against only 17.7% of patients who were treated with standard therapy.

"This is a defining moment for digital therapeutics and for patients with substance use disorder," said Corey McCann, President and Chief Executive Officer of Pear Therapeutics. "As the first FDA-cleared Prescription Digital Therapeutic for disease treatment, reSET has demonstrated improved abstinence and treatment retention in a randomized controlled clinical study. We believe that prescription digital therapeutics hold promise in improving patient outcomes across a wide range of central nervous system disorders including psychiatry, neurology and pain, and will become a vital part of tomorrow’s treatment paradigm across all disease areas."

The app, though designed for those with addiction problems, is not indicated for use in those who are addicted to opioid painkillers. The company has an app that is specifically designed for those suffering from opioid addiction currently under submission to the FDA, called reSET-O.

This method of treatment that does away with needing medication brings with it the major benefit of lacking side-effects. This explains why there is such excitement about the potential of this area, with Pear recently having raised $20 million in financing for its digital applications portfolio.