FDA has given the thumbs up to reSET, a prescription digital therapeutic from Pear Therapeutics. The offering is now cleared for use as an adjuvant to standard outpatient therapy to treat patients with substance use disorder for stimulants, cannabis, cocaine, and alcohol. This the first FDA-cleared mobile medical application system for treating patients with substance use disorders.

“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 company press release. “As the first FDA-cleared Prescription Digital Therapeutic for disease treatment, reSET has demonstrated improved abstinence and treatment retention in a randomized controlled clinical study. We believe that prescription digital therapeutics hold promise in improving patient outcomes across a wide range of central nervous system disorders including psychiatry, neurology, and pain, and will become a vital part of tomorrow’s treatment paradigm across all disease areas. Pear was impressed by the collaborative approach the FDA took in reviewing this innovative technology.”

The reSET digital therapeutic can be downloaded and activated using a prescription access code from a clinician. Patients receive 12 weeks of digital neurobehavioral therapy based on the Community Reinforcement Approach. Clinicians can track a patient’s progress using the system as well.

According to the company, the digital therapeutic was studied in an unblinded, multi-site 12-week trial with 399 patients. A statistically significant increase in adherence to abstinence from substances was seen in patients who received a reduced amount of in-person counseling in combination with reSET therapy when compared to patients who received only the standard amount of in-person counseling.

The FDA clearance of the de novo request for reSET comes as the agency is reshaping its role in regulating digital health devices. In recent months, FDA has announced its Digital Health Innovation Action Plan, which includes the new Software Precertification Pilot Program. FDA Commissioner Scott Gottlieb, MD, has also written about the agency’s desire to play a role in furthering breakthroughs in digital health offerings.

ReSET is not indicated for use in patients with opioid dependence. Pear Therapeutics is developing a separate offering, reSET-O for treating opioid use disorder. Other therapeutic apps to treat conditions such as post-traumatic stress disorder, pain, schizophrenia, and general anxiety disorder are also being developed by Pear Therapeutics.

“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 in CDRH, said in an FDA news release. “More therapy tools means a greater potential to help improve outcomes, including abstinence, for patients with substance use disorder.”