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FDA allows marketing of Reset mobile app for addiction treatment

The FDA has permitted marketing of the Reset device from Pear Therapeutics, a mobile medical application intended for use with outpatient therapy to treat substance use disorders with the exception of opioid dependence.

The device is indicated as a prescription-only adjunctive treatment for individuals with substance use disorders not currently receiving opioid replacement therapy, who do not abuse solely alcohol or whose primary substance of abuse is not opioids.

The Reset device includes a patient application and clinician dashboard. It provides cognitive-behavioral therapy to patients to teach user skills intended to increase abstinence from substance abuse and retention in outpatient therapy programs.

The FDA reviewed Reset under the de novo premarket review pathway.

Efficacy of the device was indicated in a multi-site, unblinded 12-week clinical trial. The trial included 399 individuals who received standard treatment or standard treatment with a desktop version of Reset, which could be accessed in the clinic or at home.

Abstinence adherence significantly increased among participants with alcohol, cocaine, marijuana and stimulant substance abuse disorders who received Reset compared with participants who did not receive the device (40.3% vs. 17.6%).

Data did not indicate efficacy of Reset for participants with opioid use disorder.

Adverse events, including cardiovascular disease, gastrointestinal events, depression, mania, suicidal behavior, suicidal ideation and attempts, were not found, according to researchers.

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