By Eric Wicklund, mHealth Intelligence | November 27, 2018

The first mHealth platform to receive federal approval for the treatment of people with substance abuse issues is now available to providers as a prescription-based digital therapeutic.

The reSET mHealth app, developed by Pear Therapeutics, offers a 12- week (90-day) treatment plan featuring interactive treatment modules that deliver cognitive behavioral therapy and fluency training to reinforce proficiency.

“Patients with Substance Use Disorder deserve access to more effective, convenient, and innovative treatment options,” Par Therapeutics President and CEO Corey McCann, MD, PhD, said in a press release announcing the treatment’s availability. “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.”

In September 2017, the US Food and Drug Administration approved the reSET mHealth app for use by prescription only as an adjunct treatment for patients “with SUD who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or whose primary substance of abuse is not opioids.”

(reSET-O, a separate prescription digital therapeutic designed for treating Opioid Use Disorder, was granted Expedited Access Pathway designation in October 2017 and is currently under review by the FDA.)

Earlier this year, Pear Therapeutics announced a partnership with Sandoz, a division of the pharma giant Novartis, to commercialize both reSET and reSET-O. Shortly thereafter, the two companies announced plans to develop new digital health treatments for schizophrenia and multiple sclerosis.

“With widespread adoption of digital devices, prescription digital therapeutics could potentially play an important role in future treatment models for a range of diseases with high unmet medical need, used both alone and in combination with systemic agents,” Jay Bradner, MD, President of the Novartis Institutes for BioMedical Research, said in a press release.

The reSET app is intended for use alongside outpatient therapy and in addition to a contingency management system, a widely-used program for treating SUD that uses a series of incentives to reward patients for adherence to their treatment program.

“This is an example of how innovative digital technologies can help provide patients access to additional tools during their treatment,” Carlos Peña, PhD, MS, director of the Division of Neurological and Physical Medicine Devices in FDA’s Center for Devices and Radiological Health, said in an announcement accompanying FDA approval. “More therapy tools means a greater potential to help improve outcomes, including abstinence, for patients with substance use disorder.”

The treatment is part of a new wave of telehealth and mHealth services aimed at the nation’s growing substance abuse epidemic. Many look to combine real-time access to support and resources with virtual care treatment available on mobile devices, giving those struggling with substance abuse access to help at any time and in any place.

Original Article