FDA Blesses First App to Treat Substance Abuse

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 w...
Source: MDDI - Category: Medical Devices Authors: Tags: Digital Health Source Type: news