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The application receives marketing authorization as a device, and is not intended for treatment of opiate dependence.
Mobile apps have had various wellness applications, from weight monitoring to smoking cessation. Today, the United States Food and Drug Administration (FDA) pushed their clinical legitimacy a bit further by announcing that it would permit the marketing of an application called Reset (stylized "reSET"), intended to help treat substance abuse disorder (SUD) for use of alcohol, marijuana, cocaine, and other stimulants.
Of note, the application is not intended for the treatment of opioid dependence, which is perhaps the most-discussed instance of abuse in modern America.
The marketing application approval was based on results of a clinical study testing the application. In a multi-site, unblended 12-week trial, nearly 400 patients received either standard substance abuse treatment or such treatment with the addition of a desktop version of the Reset application. A far greater number of those in the Reset group, 40.3%, showed adherence to their treatment, as opposed to 17.6% of patients who did not use the application.
The app will be in mobile form (as opposed to the desktop version utilized in the trial) and is indicated and regulated as a device, though it is designed to be downloaded to a regular mobile phone or tablet. It will be available for use by prescription only as an adjunct treatment for patients “with SUD who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or whose primary substance of abuse is not opioids,” according to the FDA’s official announcement.
The study of the application’s use did not indicate any adverse events. SUD occurs when "recurrent use of alcohol and/or drugs causes clinically and functionally significant impairment, such as health problems, disability, and failure to meet major responsibilities," according to the Substance Abuse and Mental Health Services Administration
“More therapy tools means a greater potential to help improve outcomes, including abstinence, for patients with substance use disorder,” said Carlos Peña, Ph.D., M.S., director of the Division of Neurological and Physical Medicine Devices in FDA’s Center for Devices and Radiological Health, in the statement.
The FDA’s decision grants marketing permissions to Pear Therapeutics, a Boston-based company that develops what it calls “digital therapeutics” for neurological conditions. The company has extensive relationships with venture capital firms, research institutions, and pharmaceutical companies. In addition to Reset and Reset-O, intended for opioid use disorder, its pipeline also includes apps in development for the treatment of insomnia, schizophrenia, and combat post-traumatic stress disorder (PTSD).