- ReSET is the first and only FDA-authorized prescription digital therapeutic for Substance Use Disorder (SUD)
- Adding reSET to outpatient therapy significantly improved abstinence in substances of abuse and treatment retention compared to standard of care alone
- Sandoz and Novartis continue to embrace digital technologies to enhance R&D and deliver better outcomes for patients
Holzkirchen, November 19, 2018 - Sandoz, a Novartis division, and Pear Therapeutics, Inc., announced today the commercial launch of reSET for patients with Substance Use Disorder (SUD). reSET, 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. reSET 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.
"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," said Richard Francis, CEO, Sandoz. "Adding reSET to outpatient therapy enhances behaviors associated with recovery. It leverages new technology to help patients improve abstinence in substances of abuse and stay in treatment programs longer than outpatient therapy alone."
"Patients with Substance Use Disorder deserve access to more effective, convenient, and innovative treatment options," said Corey McCann, M.D., Ph.D., President and CEO of Pear Therapeutics. "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."
To support patients and clinicians, Pear Therapeutics has also launched the reSET ConnectTM 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, Inc. 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.
SUD 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 is part of the Sandoz and Novartis strategic effort to work with innovative digital health leaders to drive the next wave of medical innovation. Sandoz and Novartis are collaborating to develop technologies to monitor patient data in real-time, detect day-to-day behavioral and biological changes in condition, improve patient adherence, and ultimately enhance treatment outcomes by helping patients to take a more active role in their own healthcare.
Pear is a leader in developing prescription digital therapeutics, developing the first FDA-authorized prescription digital mobile medical application with both a safety and effectiveness label to help treat patients with SUD.
reSET is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET is indicated as a 12-week (90-day) prescription-only treatment for patients with substance use disorder (SUD), who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse.
It is intended to:
· increase abstinence from a patient’s substances of abuse during treatment, and
· increase retention in the outpatient treatment program.