FDA Approves Artificial Medicine

By: Joseph Sanford


Health tech companies are making a big push to digitize medicine, introducing novel tools like digital pills that track when patients take their drugs and smart spoons that can automatically adjust to hand tremors. Now they want some patients to get prescription treatments from the app store as well.



Later this year, doctors treating patients addicted to substances like cocaine and amphetamines will be able to prescribe Reset, an app that gives patients lessons to help them modify their behavior. The Food and Drug Administration cleared it in September of 2017 as the first mobile medical app to help treat substance-use disorders.



Dr. McCann, a former neuroscientist and venture capitalist, co-founded Pear Therapeutics in 2013. The start-up has since raised $70 million and licensed a variety of digital therapeutics from researchers and other companies. The Reset mobile app, for instance, is based on a web-based addiction therapy program. It was originally developed in the late 1990s by behavior modification researchers who digitized long-established methods of in-person addiction therapy.



Reset is not the first prescription mobile medical app. The F.D.A. previously cleared software like BlueStar Rx, a prescription diabetes management app. But Reset is different because its primary focus is not disease management. It delivers an established behavior-modification treatment for addiction — which traditionally involves face-to-face outpatient therapy — entirely in digital form. In other words, the app itself is the medicine.



Anyone will be able to download the Reset app, expected to be available in the second half of the year. But to get it to work on a smartphone, patients must enter a prescription access code. A prescription will be good for 90 days. The F.D.A. cleared the app to be used in conjunction with outpatient therapy.



The Reset app contains 61 therapy units, with titles like “Coping With Thoughts About Using,” including lessons, skills-building exercises and quizzes on the material. The recommended dose: four therapy lessons per week. The idea behind the app is to teach patient skills — such as avoiding situations that trigger their substance use or learning how to refuse an offer of drugs — to modify their behavior, thereby promoting abstinence.



The app has a dashboard that doctors can use to monitor their patients’ progress. After patients complete a lesson, they receive encouraging feedback or gift cards — an established method for replacing addiction highs with more benign stimuli. Patients also receive rewards if they test negative for substance use.



In clinical trial results that Pear submitted to the F.D.A., substance-abuse patients who used online therapy lessons had higher abstinence rates after nine to 12 weeks than patients who had not used them. Addiction is often chronic, however, and six months after the study, abstinence rates among the two patient groups were about the same.



The arrival of Reset coincides with an F.D.A. effort to introduce more flexible ways of regulating digital health software for patients. Because such apps pose little risk to patients, they face a lower bar for agency authorization than high-risk prescription drugs or devices implanted in the body, said Bakul Patel, the associate director for digital health at the F.D.A.’s Center for Devices and Radiological Health.



The Reset app has the potential to gain a slice of the $35 billion addiction treatment market, and pave the way to treat other conditions, like depression and anxiety, Mr. Nachman said. Akili, another digital medicine start-up, is developing prescription video games to treat childhood attention deficit hyperactivity disorder.





“Even five years ago, this was science fiction,” Dr. Bradner said. “We are in a brave new world of therapeutic potential.”