FDA Clears Mobile App that Supports Opioid Use Disorder Treatment

The US Food and Drug Administration (FDA) cleared reSET-O, a mobile medical application that helps increase the retention of patients with opioid use disorder (OUD) in an outpatient treatment program.

Sandoz Inc., a division of Novartis, and Pear Therapeutics, Inc., announced the FDA’s decision on the prescription cognitive behavioral therapy, which is intended for use alongside transmucosal buprenorphine medication-assisted-treatment and contingency management. The app is indicated for patients 18 years of older who are under the supervision of a clinician.

A patient can directly download the reSET-O app after they have received a doctor’s prescription. The app provides a compliance reward system in which patients can earn special icons on a prize wheel within the app. The app is also a channel for patients to self-report data including cravings, triggers, and their use of buprenorphine.

"Nearly 50,000 drug overdose deaths involving opioids, including prescription pain medications and heroin, took place in the US in 2017," said Corey McCann, MD, PhD, president and CEO of Pear Therapeutics. "There is an urgent need for new and innovative therapeutics to address this public health epidemic. This groundbreaking 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."

Earlier this year, the FDA approved reSET, a similar app designed to treat substance use disorders. reSET-O was reviewed through the 510(k) pathway, in which the company is required to demonstrate that the device is at least as safe and effective as a previously cleared and legally-marketed device.

The clearance is part of a larger effort by the FDA to address the ongoing opioid crisis in the United States, according to FDA commissioner Scott Gottlieb, MD.

"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. That's why, for example, we launched an innovation challenge earlier this year to promote the development of medical devices that could help treat addiction," said Gottlieb in a statement.

The FDA’s decision to clear the app was supported by data from a multi-site, unblinded, controlled clinical trial. The 12-week trial included 170 participants who received treatment with buprenorphine in addition to a behavior therapy program, with or without the addition of the desktop version of reSET-O, which was accessed at the clinic. Patients received buprenorphine in a supervised setting and underwent urine screens 3 times per week. They participated in a contingency management system that provided rewards for negative urine tests.

The app did not decrease illicit drug use in the active group compared to the control group, but it did increase program retention. Patients who used the desktop reSET-O app hand and overall retention rate through 12 weeks of treatment of 82.4% compared with 68.4% for patients in the control group.

“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," concluded Gottlieb.