FDA Approves First-Ever Mobile App for Addiction Treatment

The FDA recently approved the marketing of the first-ever prescription digital therapeutic to be used in the treatment of substance use disorder (SUD).

The reSET® mobile app, developed by Pear Therapeutics, is approved to assist individuals undergoing outpatient therapy for alcohol, cocaine, marijuana, and stimulant addictions.  The application is not intended for use in treating opioid dependence, however.

The reSET® application is designed to provide a form of treatment called cognitive behavioral therapy.  It teaches SUD patients practical skills that help them abstain from using drugs and stick with their rehab programs, and provides a series of reward-based incentives.  reSET® is not approved as a standalone treatment.  Instead, it is designed to be used in conjunction with outpatient addiction therapy.

“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 Division of Neurological and Physical Medicine Devices in FDA’s Center for Devices and Radiological Health.  “More therapy tools means a greater potential to improve outcomes, including abstinence, for patients with substance use disorder.”

reSET® was reviewed through the FDA’s de novo premarket review pathway, a regulatory scheme for low- to moderate-risk devices for which there is no legally marketed predicate to which the device can claim substantial equivalence.  The FDA reviewed data from a multi-site, unblinded 12-week clinical trial of 399 patients.  In this trial, patients with alcohol, cocaine, marijuana, and stimulant SUD who used reSET® demonstrated statistically significant greater adherence to abstinence (40.3 percent) compared to patients not using reSET® (17.6 percent).

Corey McCann, President and CEO of Pear Therapeutics stated in a company press release:

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.

Regulatory approval of reSET® may represent an important step forward in the use of mobile applications to treat people with psychological, neurological and substance abuse disorders.

Neil Anderson
Neil Anderson's practice emphasizes patent litigation and prosecution in the chemical, biochemical, and pharmaceutical fields. As an undergraduate, Neil collaborated in designing and developing microfluidic tools to aid physicians in quantifying biochemical markers that are indicative of disease. He also aided in synthesizing small RNA-binding molecules as a potential new method of treating HIV and bacterial infections. He received his Juris Doctor from Cornell Law School, where he was a Managing Editor of the Cornell Law Review. Neil worked as a summer associate at the firm in 2014 and joined the firm in 2015.
Click here to read full bio
View all posts published by Neil Anderson »

Leave a Reply

By using this blog, you agree and understand that no information is being provided in the context of any attorney-client relationship. You further agree and understand that nothing herein is intended to be legal advice. This blog is solely informational in nature, and is not intended as, and should not be used as, a substitute for competent legal advice from a retained and licensed attorney in your state. Knobbe Martens LLP makes no representations or warranties as to the accuracy, completeness, timeliness or availability of the information in this blog. Knobbe Martens LLP will not be liable for any injury or damages relating to your use of, or access to, any such information. Knobbe Martens LLP undertakes no obligation to correct or update information on this blog, which may be incorrect or become incorrect or out of date over time. Knobbe Martens LLP reserves the right to alter or delete content or information on the blog at any time. This blog contains links and references to other websites and publications that you may find of interest. Knobbe Martens LLP does not control, promote, endorse or otherwise have any affiliation with any other websites or publications unless those websites or publications expressly state such an affiliation. Knobbe Martens LLP further has no responsibility for, and makes no representations regarding, the content, accuracy or any other aspect of the information in such websites or publications.