FDA approves mobile app to help treat substance abuse

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The FDA approved the app on the strength of clinical trial data showing it increased abstinence.

In a first, the FDA has approved a mobile app for use in the treatment of substance-use disorders (SUDs). The Pear Therapeutics app delivers cognitive behavioral therapy to help patients abstain from substance abuse and stay in outpatient support programs.

Pear designed the app, Reset, to complement outpatient therapy programs and the widely used, incentive-driven contingency management system. Reset does this by rewarding patients for abstaining from substance abuse and completing modules covering craving management, life skills and other fields. Pear expects patients to use the app a few times a week. Physicians can track their patients’ progress on their own dashboard.

Working out of offices in Boston and San Francisco, Pear has put the app through about five clinical trials that tested it on upward of 1,500 patients. The centerpiece of the clinical trial program was a 12-week, 399-patient study that formed the bedrock of Pear’s application for approval through the de novo premarket review pathway.

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In the indications in which Reset is approved, it can be used widely. That reflects the clean safety profile seen in the pivotal clinical trial. Investigators reported cardiovascular disease, gastrointestinal events, depression, mania, suicidal behavior and suicidal ideation and attempts. But these adverse events are typical of SUD patients and there is no evidence of side effects associated with the app. 

For Pear, the approval is an early validation of its therapeutic approach. Since raising $20 million from investors including 5AM Ventures last year, the startup has advanced a pipeline of digital therapies.

Reset is the most advanced of five programs. A related opioid dependence device, Reset-O, that adds pharmacotherapy modules to address compliance and adherence is following its sibling down the pipeline. Further back, Pear is working on digital treatments for schizophrenia, PTSD and generalized anxiety disorder. 

The Reset approval shows that, if it can generate data to support their use, Pear will find the FDA open to greenlighting the follow-up products. 

“This is an example of how innovative digital technologies can help provide patients access to additional tools during their treatment,” Carlos Peña, Ph.D., director of the FDA’s division of neurological and physical medicine devices, said in a statement. “More therapy tools means a greater potential to help improve outcomes, including abstinence, for patients with substance use disorder."