FDA clears app for patients in treatment for opioid use disorder
The FDA has approved a mobile medical app that could increase the time a patient participates in an outpatient treatment program for opioid use disorder, according to a FDA press release.
The app (reSET-O, Pear Therapeutics) is a prescription cognitive behavioral therapy intended to be used in conjunction with outpatient, supervised treatment that includes buprenorphine and contingency management, according to the release.
The app was approved after a 12-week clinical trial of 170 patients with opioid use disorder who received supervised buprenorphine treatment paired with a behavior therapy program. Those who used a desktop version of the app showed a statistically significant increase in retention in a treatment program vs. those who did not use the desktop version of the app, according to the FDA.
The app is not intended to be used as a stand-alone therapy as a substitute for medication, or for patients whose primary language is not English, according to the release.
“As part of our efforts to address the misuse and abuse of opioids, we're especially focused on new tools and therapies that can help more people with opioid use disorder successfully treat their addiction. Medical 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,” FDA Commissioner Scott Gottlieb, MD, said in a release.
“Providing Americans suffering from opioid use disorder with more options and proper support to address treatment challenges is key to helping them succeed. We know medication-assisted treatment works and we support novel ways to keep individuals more engaged in their treatment programs and to provide clinicians with new ways to intervene to help them remain in treatment,” he continued.
Disclosure: Gottlieb is FDA commissioner.