Prescription digital company Pear Therapeutics said on Thursday that the US Food and Drug Administration (FDA) has approved its De Novo request to market reSET for the treatment of patients with substance use disorder (SUD) under a new class of treatment.

This is the first time that the US FDA has cleared a Prescription Digital Therapeutic with claims to improve clinical outcomes in a disease. The prescription digital therapeutics are clinically validated, FDA-cleared software applications that demonstrate safety and efficacy in randomised clinical trials to improve patient outcomes.

According to the company, reSET is a 12-week duration, US FDA-cleared Prescription Digital Therapeutic to be used in conjunction with standard outpatient treatment for substance use disorder related to stimulants, cannabis, cocaine, and alcohol. The product combines patient-facing interventions and assessments via a mobile device, with clinician-facing dashboards and data analytics on the back-end.

A National Institute on Drug Abuse (NIDA) sponsored clinical trial evaluated the company's reSET therapeutic in 399 patients with SUD across ten treatment centres in NIDA's Clinical Trial Network nation-wide over 12 weeks .

Under the NIDA trials, the patients were randomized to either a standard treatment-as-usual, which consisted of standard face-to-face counseling, or to a reduced amount of face-to-face counseling plus the digital therapeutic reSET. The clinical study demonstrated that the digital therapeutic more than doubled the rate of abstinence compared to standard, face-to-face counseling.