FDA Approves The First Prescription-Only Addiction Treatment App

With the rise and evolution of smartphone apps and technology, it’s no surprise that the addiction treatment and recovery industry is eyeing the digital market. With multiple apps already available, biotech company Pear Therapeutics set out to make a program different from the rest – a prescription-only app that helps to both enhance treatment and reduce relapse for individuals struggling with addiction to alcohol, opioids, and other drugs.

Pear was able to achieve this with the invention of their reSET-O mobile medical application – a prescription-only cognitive behavioral therapy app that is used in conjunction with medical supervision and outpatient treatment. The app launched this past January through a profit-sharing deal with Novartis’ Sandoz that includes a dedicated sales force, representing the first time that a Big Pharma has directly sold a piece of software. Results showed that patients working with the program were more than twice as likely to abstain from alcohol, cocaine, and marijuana, compared to those without the application. Pear even won the approval of the Food and Drug Administration (FDA) in 2018 and is now considered to be the leader in FDA-cleared Prescription Digital Therapeutics (PDTs).

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How The ReSET-O App Works

The “ReSET” app works by using aspects of Cognitive Behavioral Therapy (CBT) to help patients better recognize situations that cause emotional and behavioral responses that trigger substance use. Upon downloading the app, the patient unlocks it with a passcode from their clinician and then has access to the product for 12 consecutive weeks. During those 12 weeks, patients are able to interact with the product and answer questions pertaining to mood, hunger, cravings, and loneliness. All of this information goes to their supervising clinician to help open communication and reinforce physician-patient interaction. This also allows for the patient to see how well or bad they are doing recovery wise with their week-to-week data available right in front of them.

Those using the app will complete a set of four modules each week that uses a specific type of neuro-behavioral intervention for addiction. There are 67 modules in total, and each uses a combination of video, audio, and text to teach the patient what to do in different scenarios dealing with substance use, including: managing thoughts about using, refusing drugs or alcohol, mood management, communication, and interpersonal relationship problems. Upon completing those modules, patients will receive rewards for their continued usage that also incentivizes them to continue participating with the software.

Pear CEO Corey McCann believes that in addition to their engaging content, their incentive program is what truly sets them apart from other addiction treatment apps: “Patients receive everything from badges and digital ‘at-a-boys’ to things like gift cards from Starbucks and things of nominal financial value which can’t be exchanged for substances of abuse. Each of the patients interacts with these different reward schedules in different ways. A good deal of the novelty is in pairing up the right patient with the right reward corresponding to the right amount.”

Clinical trials of the reSET-O app corroborates McCann’s claims, as 40.3% of app users adhere to their treatment programs compared to only 17.6% of people that had standard treatment without the use of the app.

Despite the success, some are skeptical that this may further limit access to individuals struggling with addiction as it requires a prescription. However, Pear Therapeutics maintains that the available by-prescription-only model is suitable as addiction needs to be looked at and taken seriously as the condition it is – a disease.

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Jena Hilliard

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  • Jena Hilliard earned her Bachelor’s of Arts degree from the University of Central Florida in English Literature. She has always had a passion for literature and the written word. Upon graduation, Jena found her purpose in educating the public on addiction and helping those that struggle with substance dependency find the best treatment options available.

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