Pear Therapeutics Launches reSET App, First FDA-Cleared Digitally Prescribed Therapy

Pear Therapeutics has recently teamed up with Sandoz, a Novartis branch, to release reSET, the first and only FDA-approved prescription digital therapeutic. The app is designed to help those with substance use disorders conquer their addictions and uses psychological therapies in concert with physician-delivered care to do so.

Study results from a randomized clinical trial conducted at multiple locations showed that when used alongside outpatient therapy and management, reSET significantly reduced substance abuse and increased retention time. These results were observed to outperform those of outpatient therapy alone. This clinical trial was validated through the National Institute of Drug Abuse (NIDA) Clinical Trial Network.

reSET users undergo a 12-week prescription therapy that is used in conjunction with physician care. The app itself delivers interactive treatment modules containing cognitive behavioral therapy and fluency training designed to enforce abstinence from drugs. Physicians have access to a personalized dashboard that allows them to follow self-reported substance abuse, cravings, and triggers from their patients. This feature enhances transparency between the patient and provider, allowing the patient to give real-time data regarding their drug addiction that better prepares physicians for face-to-face meetings.

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“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 of 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.”

Pear Therapeutics has also created the reSET Connect Patient Service Center to support patients and physicians. This service gives a specialist access to reSET, allowing them to walk patients and clinicians through the process of downloading and accessing the app, troubleshooting issues, and working with insurance companies to facilitate the overall treatment process.

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“Patients with Substance Use Disorder deserve access to more effective, convenient, and innovative treatment options,” said Dr. Corey McCann, 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.”

This past April, Sandoz partnered with Pear Therapeutics to further develop and commercialize the reSET app. This collaboration utilizes Sandoz’s experience in launching treatments and therapies with Pear’s expertise in digital prescription therapeutics design to create the innovative, one of a kind reSET app.

“We have a team of salespeople who are going out and educating clinicians about the product, its data, how to use it; and we also have a set of services that support dispensing, but they aren’t selling to the clinicians,” said Dr. Yuri Maricich, Pear’s chief medical officer and head of clinical development. “Also, that dispensing and fulfillment process allows the physician to access the dashboard and the therapeutic for their patient as well. And in the background we work with payers around coverage and contracts. So, really, what we’re focusing on now is getting the therapeutic in the hands of patients who need it and helping clinicians understand how to use it, who’s the right patient for it, how do I prescribe it and interact with it as part of standard care.”

Sources: AP News, MobiHealthNews