The Food and Drug Administration on Sept. 14 approved the marketing of reSET, a mobile app developed by Pear Therapeutics that is intended to treat addiction.
This marks the first time the FDA has permitted the use of a prescription digital therapeutic device to treat a disease. Digital therapeutics, a growing trend in health care, uses software rather than medication to improve a person’s health.
“This is a defining moment for digital therapeutics and for patients with substance use disorder,” Corey McCann, president and CEO of Pear Therapeutics, said in a statement.
ReSET is a digital form of therapy that clinicians prescribe during outpatient care. The device uses cognitive behavioral therapy to help treat addictions to marijuana, stimulants, cocaine and alcohol.
Although the app has not been approved to treat opioid dependence, Pear Therapeutics created a version of the software for use with opioid replacement therapies. The company is currently preparing to submit the software to the FDA for review.
ReSET provides cognitive behavioral therapy to help clients identify, understand and change dysfunctional behaviors. This approach examines the relationship between a person’s behaviors, feelings and thoughts.
The app delivers a 12-week course of treatment intended for adult patients battling addiction who:
To maximize its effectiveness, reSET is designed to be used alongside traditional outpatient treatment and contingency management, a therapy approach that reinforces positive behaviors with tangible rewards.
The app aims to reduce substance use among people with addiction and increase retention in outpatient treatment programs. ReSET also allows medical providers to access their patients’ self-reported substance use, cravings, triggers and outcomes.
In a press release, Dr. Carlos Peña, director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said that reSET is an example of how digital technology can provide additional resources to people during rehab.
“More therapy tools means a greater potential to help improve outcomes, including abstinence, for patients with substance use disorder,” Peña said.
To test the effectiveness of reSET for treating addictions to cocaine, alcohol, marijuana and stimulants, the FDA reviewed data from a 12-week clinical trial sponsored by the National Institute on Drug Abuse. In the study, 399 patients with addiction received either standard treatment or standard treatment in combination with a desktop-based version of reSET.
Two times per week, researchers measured abstinence from drug and alcohol use with urine analysis, Breathalyzer tests and self-reports. The results showed that the abstinence rate of patients who used reSET was more than double the rate of those who received treatment without the app.
“The clinical outcomes demonstrated in the reSET pivotal study are remarkable,” Edward V. Nunes, professor of psychiatry at Columbia University Medical Center and lead investigator of the study, said in a statement. “Clinically validated digital therapeutics may become a cornerstone of future treatment.”
ReSET is part of a growing trend in the medical community: digital therapy.
Digital therapeutics use digital or online technology to enhance traditional behavioral therapy. The software applications assist in treating disease by changing patient behaviors and providing remote monitoring to doctors. Through digital therapy, health professionals can track their patients’ progress and give daily feedback.
These devices incorporate patient-facing applications, assessments and outcome monitoring, tracking dashboards for clinicians and HIPAA-approved data storage. In randomized clinical studies, digital therapeutics are required to display efficacy and safety.
App developers and health care professionals have taken notice. A number of health companies in Silicon Valley are developing digital therapy devices. And many physicians, health plans and employers have supported the use of digital therapeutics.
Today, companies are creating digital therapeutics to assist in the treatment of opioid dependence, insomnia, chronic disease and other disorders. Many believe this innovative form of therapy is a cost-effective approach that bypasses the side effects of medication-based treatment.