Drug and alcohol users will soon be able to get prescriptions for a mobile app that could help them stay clean. Developed by Pear Therapeutics in Boston and San Francisco, the app helps people recovering from addiction stay on track while participating in outpatient treatment. The U.S. Food and Drug Administration (FDA) last week approved the prescription-only software for the American market.
The FDA’s decision marks the first time in the United States that software has been approved to treat disease, says Corey McCann, founder and CEO of Pear Therapeutics. The company plans to make the digital therapeutic available commercially in 2018, he says.
The app, called reSET, is aimed at people with substance use disorders involving alcohol, marijuana, cocaine, and stimulants. Patients prescribed the software must be involved in some type of outpatient treatment. Only a prescription will enable the patient to unlock the software and use it.
The app prompts patients each week to answer questions that help them stay on top of their cravings and keep them educated about ways to deal with their addiction—a type of treatment called cognitive behavioral therapy. “It’s very much like what patients would get face-to-face,” with clinicians, says McCann.
Patients can use the app to report cravings and what they think is triggering them, along with any slip-ups. The information gets sent to the patient’s clinician, who can view the activity on a back-end dashboard. “It can help clinicians have more effective in-office visits,” says McCann. Clinicians can use the information to help patients identify behavioral patterns that might lead to relapse.
The FDA based its approval largely on data from a 12-week clinical trial of 399 patients who received either standard treatment or standard treatment with the addition of the software program. The study found that patients using the digital therapy had a more than 20-percent greater adherence to the treatment program and abstinence from the substance than patients undergoing standard treatment alone.
Pear Therapeutics spent at least $20 million developing the software program and testing it in clinical trials. Now, to recoup the investment, the company has to convince payers to see the value of the software and cover it in their insurance plans.
The FDA in 2010 approved another prescription-only app, called BlueStar, for use by people with Type 2 diabetes. BlueStar offers motivational and educational messages, and makes suggestions, in real time, about when to test blood sugar. But the app wasn’t approved to treat disease, so Pear Therapeutics had to forge its own regulatory pathway with the FDA in order to make the claim that its app treats disease.
The prescription-only model could have drawbacks. “Making medical apps available only by prescription would limit access to the people who need it, and the overall public health impact,” says Jonathan Bricker, a scientist and smoking cessation researcher at Fred Hutchinson Cancer Research Center in Seattle. “Unless these apps pose medical risks to patients, making them prescription-only undermines the greatest potential of mobile health technology: to reach millions of people at low cost and thereby reduce the morbidity and mortality of disease on a global scale.”
Indeed, the U.S. government has posted a list of recommended quit-smoking apps that can be accessed without a prescription. And many groups have developed digital psychiatry software. Some of these medical apps have been proven effective in rigorous testing, says Bricker, and “they don’t need FDA approval to be distributed because they pose no risk to the patient,” he says.
But by and large, most apps on the market lack clinical validation, so while many may be available directly to the public, it’s unclear how well each one works. In 2015, researchers reviewed the 14 depression apps endorsed by England’s publicly funded health care system, the National Health Service, and found that only two of them had been clinically validated. That followed a slew of reports finding that mental health apps lacked rigorous testing.
“Ultimately, digital therapeutics will likely play out much like drugs versus nutritional supplements,” says McCann. “Since using digital therapeutics to treat diseases such as substance use disorder (SUD) does indeed pose risk to patients, we believe that prescription-only is the best means of distribution. This might not be an issue for products treating smoking cessation or other wellness issues, but for SUD...and the other severe medical conditions in our pipeline, demonstration of safety data, and physician prescription are critical for patient safety.”
Pear Therapeutics is developing additional apps for opioid abuse, schizophrenia, post-traumatic stress disorder, generalized anxiety disorder and other conditions. It plans to apply for FDA approval for each additional program.
An abridged version of this post appeared in the November 2017 print issue as “FDA Approves a Prescription-Only App for Addiction.”