An adjunct to outpatient therapy, the application is geared to help treat addiction.

Federal regulators approved Pear Therapeutics' first mobile medical application to help treat substance abuse disorders. The technology is intended to be used with outpatient therapy to help those gain control of alcohol, cocaine, stimulant and other SUDs. According to the FDA, the application is not intended to be used to treat opioid dependence.

FDA said Pear Therapeutics’ “Reset” is a mobile medical app, which features a user-patient function and a clinician dashboard. The applications and device, said regulators, deliver cognitive behavioral therapy to patients to help them learn skills that aid in treatment and help abstain from substance abuse. The app is intended as an adjunct to other outpatient therapy and designed to work with abuse-deterring contingency management systems, widely used, said FDA, for treating SUD through a series of incentives and rewards for patients adhering to their treatment program.

"This is an example of how innovative digital technologies can help provide patients access to additional tools during their treatment," said Carlos Peña, director of the Division of Neurological and Physical Medicine Devices in FDA's Center for Devices and Radiological Health. "More therapy tools means a greater potential to help improve outcomes, including abstinence, for patients with substance use disorder."

The FDA reviewed data from a multi-site, unblended 12-week clinical trial involving 399 patients who either received standard treatment or standard treatment with the app. Federal regulators said the data showed a ”statistically significant increase in adherence to abstinence” for the patients with alcohol, cocaine, marijuana and stimulant SUD in those who used Reset (40.3%), compared to the patients who did not (17.6%). Data from the clinical studies, said FDA, did not reveal any side effects associated with using the device in its therapeutic setting.