The FDA exercises an important role in American medicine, regulating new drugs and devices to ensure patient safety. Now, for the first time, they are adding mobile apps to that list. An app called Reset, developed by Pear Therapeutics, is intended to be used in conjunction with outpatient therapy to help treat substance use disorders. At present, the Reset app is intended to be used with outpatient therapy to treat alcohol, cocaine, marijuana, and stimulant substance abuse disorders, but is not intended to be used with opioid dependence.
“This is an example of how innovative digital technologies can help provide patients access to additional tools during their treatment,” said Carlos Peña, Ph.D., M.S., director of the neurological and physical medicine devices at the FDA when the approval was announced. “More therapy tools means a greater potential to help improve outcomes, including abstinence, for patients with substance use disorder.”
Pear’s CEO had previously characterized FDA approval as “a watershed moment for digital health.” The FDA considers some mobile apps to meet the definition of medical device. However, it had yet to formally approve an app before now. Approval means that the Reset app can be prescribed by a doctor just like a medication.
“We believe that prescription digital therapeutics hold promise in improving patient outcomes across a wide range of central nervous system disorders including psychiatry, neurology and pain, and will become a vital part of tomorrow’s treatment paradigm across all disease areas,” said Pear’s President and CEO Corey McCann, in a statement after the FDA’s announcement. “Pear was impressed by the collaborative approach the FDA took in reviewing this innovative technology.”
The Reset app is based on a form of therapy called cognitive behavioral therapy, that looks to examine the relationships between thoughts, feelings, and behaviors. It aims to teach users skills to aid in the treatment of their substance abuse through a series of 62 modules. Lessons cover topics like refusing drugs, managing thoughts about using, and improving psychosocial functioning, including time management, communication, mood management, and interpersonal relationships.
FDA approval came after a clinical trial of 399 patients in 10 outpatient addiction treatment programs across a 12-week period. The study found that use of the Reset app, in conjunction with in person counseling, improved treatment retention rates and abstinence rates. Of the patients using the Reset app, 40.3 percent were abstinent by the end of the study, compared to 17.6 percent in a control group that did not use the app.
Apps like Reset are being examined as treatment options for a variety of conditions, ranging from addiction to diabetes. The Reset app is a trailblazer. By becoming the first mobile app to be approved by the FDA, it has established a precedent by which an app can become a treatment open to insurance reimbursement, an important step to making digital medicine economically viable.
The FDA approval process took several years and helped the agency to develop a new classification for digital therapeutics that it considers low risk. As a result, many observers think that the FDA approval process will be easier for future apps.
Additionally, the Reset app may be an important addition to America’s fight against addiction, since it is able to take treatment into areas that may be underserved by present providers.
Lack of access to addiction treatment centers is a growing problem for the U.S. There are only 14,148 treatment facilities nationwide. The majority of them do not offer either inpatient treatment or treatment for opioid abuse. Each year, hundreds of thousands of people struggle to find a treatment facility with available space for them. Much of this stems from regulations governing Medicaid reimbursements, which limit how many patients each center can house.
In 1965, the federal government passed a rule limiting Medicaid funding to community-based mental-health and addiction treatment centers with 16 beds or fewer. The rule was intended to prevent the redevelopment of massive institutions under a new name. In practice, it severely limited the availability of treatment in low-income and rural areas, where the need for addiction treatment is often greatest. The federal government has allowed states to apply for waivers, both for psychiatric treatment facilities and addiction treatment centers.
So far, there has been little sustained movement in Congress to overturn this rule. Instead, states and providers are left struggling to find alternative options.
At this point in time, the Reset app is not intended for use in treating opioid addiction; however, Pear says that it is working on another app to be used alongside opioid replacement therapies.