FDA approves opioid use disorder app for outpatient treatment

The Food and Drug Administration has granted clearance to a mobile medical app designed to help keep patients with opioid use disorder in recovery programs.

The app from Pear Therapeutics, called reSET-O, is meant to be used in outpatient treatment programs, serving as a training, monitoring and reminder tool for providers and patients.

“Often on the road to recovery, patients find their commitment to staying in treatment may wane,” said FDA Commissioner Scott Gottlieb, MD, in a written statement. “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.”

Also See: FDA launches app competition to combat opioid overdoses

The app, which is downloaded to a patient’s mobile device after it’s prescribed by a physician, is a prescription cognitive behavioral therapy intended to be used in addition to outpatient treatment under the care of a healthcare provider, along with treatment that includes buprenorphine and contingency management—a behavior modification intervention that creates a connection between new, targeted behavior and the opportunity to obtain a desired reward.

According to the FDA, it reviewed data from a multi-site, unblinded, controlled 12-week clinical trial of 170 patients who received supervised buprenorphine treatment combined with a behavior therapy program—either with or without the addition of a desktop-based version of reSET-O.

“The use of reSET-O was not shown to decrease illicit drug use any more than patients who received buprenorphine treatment and contingency management alone,” states the regulatory agency. “However, the data 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.”

Specifically, the FDA reported that patients in the clinical trial 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 percent, compared with 68.4 percent overall retention rate for patients who did not.

“The reSET-O app has not been shown to decrease illicit drug use or improve abstinence in patients with (opioid use disorder),” emphasizes the agency. “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.”

“Nearly 50,000 drug overdose deaths involving opioids, including prescription pain medications and heroin, took place in the U.S. in 2017,” says Corey McCann, MD, 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.”