The first FDA-authorized app for substance use disorder, and its maker's bankruptcy

The short version

In September 2017, the FDA allowed Pear Therapeutics to market reSET, the first mobile medical application to help treat substance use disorders. It was authorized as a prescription-only treatment. Less than six years later, on April 7, 2023, Pear filed for Chapter 11 bankruptcy. The app cleared a real regulatory bar. The business around it did not hold up.

What the FDA authorized

reSET delivers a form of cognitive behavioral therapy through lessons on a phone, with a dashboard for the clinician. The FDA's decision summary says it is meant to be used alongside a contingency management system, which rewards patients for things like completing lessons and negative drug tests.

The authorization is narrow. It covers adults 18 and older who are in outpatient treatment under a clinician's supervision. It is a 12-week, prescription-only treatment. It is not for people on opioid replacement therapy, people whose only problem is alcohol, or people whose main substance is opioids. It is an add-on to treatment, not a replacement for treatment or for medication.

The FDA reviewed it through the De Novo pathway, used for new low- to moderate-risk devices with nothing similar already on the market, and placed it in Class II. The FDA's own news release is no longer at its original fda.gov address. The copy we used is the FDA's release as distributed on PR Newswire, and the numbers below were checked against the FDA's decision summary in its De Novo database.

The evidence behind it

The FDA relied on a multi-site randomized trial run through the National Institute on Drug Abuse Clinical Trials Network. Over 12 weeks, one group got usual outpatient treatment. The other got a desktop version of reSET, accessible at the clinic or at home, in place of 2 hours a week of face-to-face therapy.

Among people whose main substance was not opioids, 40.3% were abstinent in weeks 9 to 12 with reSET, against 17.6% with usual treatment. Across everyone, including people who used opioids, it was 29.7% against 16%. People with reSET also stayed in treatment longer.

For people whose main substance was opioids, the result went the other way: 5.7% abstinent with reSET and 15.9% without. The FDA described that as a statistically significant reduction.

The FDA reported no adverse events that trial investigators judged to be caused by the device. The trial was funded by the National Institute on Drug Abuse. The desktop program was developed by a company called HealthSim, whose president consulted on setting it up but, according to the published trial, did not run the trial or analyze its data. The published trial reports its main results with a different analysis than the FDA's summary, and also found more abstinence and less dropout with the program.

What happened to Pear

On April 7, 2023, Pear announced that it and its U.S. subsidiary had filed for Chapter 11 in the U.S. Bankruptcy Court for the District of Delaware. The company said it planned to sell the business or its assets, would run scaled-down operations during the sale process, and had reached a settlement with its lender before filing.

Pear's release gave no reason for the failure. MedTech Dive reported the same day that Pear had laid off 170 employees, most of its workforce, leaving 15 people. Its CEO, Corey McCann, stepped down. The company reported $10.4 million in revenue for 2022, largely from agreements with state agencies, after setting an initial goal of $22 million.

In December 2023, Behavioral Health Business reported that the addiction treatment startup PursueCare had acquired three digital therapeutics developed by Pear. The sources for this entry do not describe how that sale was structured.

What it does not show

A bankruptcy is not a verdict on whether the app helped patients. The trial and the company's finances are separate questions.

The trial has limits the FDA itself names. The phone app was never tested; the desktop version was. The FDA concluded the app was likely to provide similar benefit because its content matched the desktop version in a side-by-side comparison. Only the reSET group could earn rewards, so the benefit of reSET without them has not been evaluated. The trial was unblinded. It did not look past 12 weeks or test whether the app prevents relapse after treatment ends. Most people used the desktop version at the clinic, which gave them extra contact with staff that the comparison group did not get. The FDA noted that people who used it off-site also showed a significant gain in abstinence over usual treatment.

The sources for this entry do not state a cause for Pear's failure beyond missed revenue goals. Explanations that point to insurance coverage are not in these sources, so we leave them out.

Why it matters

reSET showed that an app could clear the FDA as a treatment for substance use disorder. Pear showed that clearing the FDA does not keep the company behind the app in business.

If a clinician offers you a prescription app, ask two things. Is it meant for your main substance? In reSET's own trial, people whose main drug was opioids were abstinent less often with the app than without it, a difference the FDA called statistically significant. And is the reward system that came with it in the trial part of what you will get?

For programs, the lesson is about the whole package. The results the FDA reviewed came from an app plus rewards plus ongoing outpatient care. Take one piece away and the evidence no longer describes what you are offering.