reSET was validated in a randomised clinical trial through the National Institute of Drug Abuse clinical trial network. Credit: Austin Pacheco.

Sandoz, a division of Novartis, and prescription digital therapeutics provider Pear Therapeutics, have announced the commercial launch of their collaborative product reSET, designed for the treatment of patients with Substance Use Disorder (SUD).

Launched with immediate availability, reSET becomes the world’s first prescription digital therapeutic authorised by the FDA, with claims to improve clinical outcomes in a disease.

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A multi-centre, randomised clinical trial showed that reSET significantly improves abstinence in substances of abuse and increase retention when used with outpatient therapy alone.

reSET, which is meant to be used for 12 weeks (90 days) in conjunction with outpatient clinician-delivered care, underwent validation in a randomised clinical trial through the National Institute of Drug Abuse (NIDA) clinical trial network.

The new prescription digital therapeutic also offers interactive treatment modules that provide comprehensive behavioural therapy.

“A multi-centre, randomised clinical trial showed that reSET significantly improves abstinence in substances of abuse and increase retention when used with outpatient therapy alone.”

Sandoz CEO Richard Francis said: “We all have a role to play in helping find solutions that work for patients, families and communities as we fight the substance abuse epidemic.

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“Adding reSET to outpatient therapy enhances behaviours associated with recovery. It leverages new technology to help patients improve abstinence in substances of abuse and stay in treatment programmes longer than outpatient therapy alone.”

By combining patient-facing interventions and assessments through a mobile device, the product comes with clinician-facing dashboards and data analytics on the back-end.

Clinicians can follow patient-reported substance cravings, use and triggers on the dashboards and offer deeper interaction and transparency during their face-to-face meetings with patients.

Pear Therapeutics president and CEO Corey McCann said: “Patients with Substance Use Disorder deserve access to more effective, convenient, and innovative treatment options.

“reSET has been clinically validated to significantly improve outcomes for patients, while also providing patients a discreet way to access care when and where they need it. Prescription digital therapeutics will help redefine the treatment of serious diseases like Substance Use Disorder, providing improved patient outcomes, and driving clinical insights for clinicians.”

Pear Therapeutics has also launched the reSET Connect Patient Service Center for the support of patients and clinicians.