Digital health solutions could be the most viable means of curbing the opioid abuse epidemic. FDA contributed to the support of this belief earlier this week, when it gave a nod to Pear Therapeuticsâ€™ mobile medical app. The solution, called reSET-O, is used to help those with opioid use disorder stay in recovery programs.
The Boston, MA-based company said the reSET-O app is a prescription cognitive behavioral therapy intended to be used in addition to outpatient treatment under the care of a health care professional, in conjunction with treatment that includes buprenorphine and contingency management.
â€œAs part of our efforts to address the misuse and abuse of opioids, weâ€™re especially focused on new tools and therapies that can help more people with opioid use disorder successfully treat their addiction,â€ Scott Gittlieb, MD, FDA commissioner said in a release. â€œMedical devices, including digital health devices like mobile medical apps, have the potential to play a unique and important role in contributing to these treatment efforts.â€
Nearly 170 patients were evaluated in a 12-week clinical trial of a desktop version of reSET-O. Data from the trial showed a statistically significant increase in retention in a treatment program for 12 weeks for the patients who used the desktop computer version of the reSET-O program compared to those who did not. In the trial, patients who used the desktop computer version of reSET-O had an overall retention rate through the end of 12 weeks of treatment of 82.4% compared with 68.45% overall retention rate for patients who did not.
FDA used the data to make a clearance determination for reSET-O.
This isnâ€™t Pear Therapeuticsâ€™ first rodeo with FDA. In September of last year the company received a nod to market reSET, a solution that it said was the first app given approval to treat substance abuse. The app was cleared for use as an adjuvant to standard outpatient therapy to treat patients with substance use disorder for stimulants, cannabis, cocaine, and alcohol.