Sandoz — a Novartis division — and Pear Therapeutics, announced the commercial launch of reSET for patients with Substance Use Disorder (SUD). reSET, which is the first and only FDA-authorized prescription digital therapeutic, is immediately available.
Study results from a multicenter, randomized clinical trial showed that reSET, when used with outpatient therapy and contingency management, significantly improved abstinence in substances of abuse and increased retention as compared to outpatient therapy alone. The reSET therapeutic content was validated in a randomized clinical trial through the National Institute of Drug Abuse (NIDA) Clinical Trial Network.
reSET is a 12-week (90-day) prescription digital therapeutic to be used in conjunction with outpatient clinician-delivered care. It offers interactive treatment modules that deliver cognitive behavioral therapy and fluency training to reinforce proficiency. Within the clinician dashboard, clinicians can follow patient-reported substance use, cravings, and triggers to facilitate transparency and deeper interaction between patients and clinicians at face-to-face meetings.
“Adding reSET to outpatient therapy enhances behaviors associated with recovery,” Richard Francis, CEO of Sandoz, said in a statement. “It leverages new technology to help patients improve abstinence in substances of abuse and stay in treatment programs longer than outpatient therapy alone.”
To support patients and clinicians, Pear Therapeutics has also launched the reSET Connect Patient Service Center. A specialist is available to provide access to reSET, walk patients and clinicians through the steps for downloading and using reSET, troubleshoot any issues with reSET, and work with the patient’s insurance company to ensure a seamless treatment experience.
In April, Sandoz entered into a collaboration with Pear Therapeutics to commercialize and continue development of reSET — designed to effectively augment clinicians and improve clinical outcomes for patients. The collaboration brought together Sandoz expertise in launching and commercializing treatments with Pear’s leading experience in prescription digital therapeutics design, development, and implementation.
Substance Use Disorder is a chronic, relapsing disease caused by the recurrent use of alcohol or drugs — or both. For people with SUD, treatment has typically meant resource-intensive, face-to-face interactions in a specialized setting. Inconsistent quality in treatment, disparities in payment for behavioral health services, and limited accessibility has led to poor treatment outcomes, including low rates of abstinence and high dropout rates. This collaboration between Sandoz and Novartis aims to change the way SUD is treated.