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 as the first mobile medical app to help treat substance-use disorders.
"It's all the things you would traditionally associate with a pill or any other medication," said Dr. Corey McCann, the chief executive of Pear Therapeutics, the startup behind Reset. "But it just so happens to be a piece of software."
Pear Therapeutics is at the forefront of a new category of medical treatment, offering what company executives call "prescription digital therapeutics." These products, they say, are medical apps that have been studied in randomized clinical trials, cleared by the FDA, require a doctor's prescription and allow doctors to track patients' progress.
In a sign of momentum behind the idea and how it might expand to other health conditions, Novartis, the Swiss pharmaceutical giant, said it had teamed up with Pear Therapeutics to develop prescription apps for schizophrenia and multiple sclerosis.
Companies like Pear are trying to stand apart in a global market of more than 318,000 health apps by arguing that their products provide assurance of effectiveness and safety. The advantage of their prescription treatment software, they say, is that apps making general wellness claims — like meditation apps marketed to soothe you to sleep — do not require FDA review. But medical devices like apps that claim to treat or manage disease must submit clinical evidence to the FDA and get clearance.
A few medical experts, however, argue that the apps, while promoting themselves as a new medical therapy, are essentially just repackaging existing treatments. "This is a branding effort that is meaningless," said Dr. Allen J. Frances, a psychiatrist and professor emeritus at the Duke University School of Medicine. "FDA approval comes easily, and a prescription doesn't guarantee greater efficacy."
McCann, a former neuroscientist and venture capitalist, co-founded Pear Therapeutics in 2013. The startup 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 developed in the late 1990s by behavior modification researchers who digitized long-established methods of addiction therapy.
Reset is not the first prescription mobile medical app. The FDA 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 patients must enter a prescription access code. The FDA cleared the app to be used in conjunction with outpatient therapy.