Pear Therapeutics App Gets FDA Nod for Treating Opioid Abuse

Xconomy Boston — 

Doctors and other caregivers have a new weapon to combat the opioid epidemic. But it’s not a pharmaceutical drug—it’s a mobile app.

This week, the FDA cleared “reSET-O,” an app developed by “digital therapeutics” startup Pear Therapeutics, for sale in the U.S. as a treatment for patients recovering from opioid abuse disorder. Doctors can now prescribe the app to help treat the disorder by delivering cognitive behavioral therapy, specifically a series of interactive therapy lessons modeled on the Community Reinforcement Approach, a widely used approach to treat substance abuse.

The Pear app is intended to be used in tandem with outpatient treatment that includes the transmucosal drug buprenorphine as well as contingency management, a behavior modification approach that aims to create a connection between “new, targeted behavior and the opportunity to obtain a desired reward,” the FDA said.

“Providing Americans suffering from opioid use disorder with more options and proper support to address treatment challenges is key to helping them succeed,” FDA commissioner Scott Gottlieb said in a prepared statement. “We know medication-assisted treatment works, and we support novel ways to keep individuals more engaged in their treatment programs and to provide clinicians with new ways to intervene to help them remain in treatment.”

Patients can use reSET-O to report their substance use, opioid cravings, and things that trigger cravings. They can also configure the app to send reminders to take their buprenorphine. Patients can earn rewards—ranging from digital smiley faces to Starbucks gift cards, Pear CEO Corey McCann says—when they pass drug screening tests and achieve tasks in the app, such as completing therapy lessons. The idea is to encourage desired behaviors by linking them with rewards that might trigger the release of dopamine in the patient’s brain, McCann says.

“These are very, very powerful motivators for these particular patients because they have a dopamine imbalance,” he says.

The announcement further establishes Pear, which has offices in Boston and San Francisco, as one of the leaders of the nascent field of digital therapeutics, in which electronics such as smartphone apps serve as the therapy or a key component of the treatment plan. Other notable players in the industry include Boston-based Akili Interactive Labs and San Diego-based Dthera Sciences, which both have software products under FDA review, and New York-based Click Therapeutics, which raised $17 million in July in a venture round led by Sanofi Ventures.

This marks Pear’s second FDA nod for a prescription digital therapeutic. In September 2017, a similar app dubbed “reSET” was granted marketing clearance, making it the first software product permitted by the FDA as a prescription treatment for a disease. That marketing clearance covered substance use disorder—specifically helping patients struggling with addiction to alcohol, cocaine, marijuana, or stimulants—and the app is intended to be prescribed in conjunction with standard outpatient treatment programs. Opioid dependence was not covered under that FDA decision.

The reSET-O clearance now adds opioids to Pear’s product portfolio. The app is also notable because it’s the first drug-software combination approved to treat a disease, according to McCann. The FDA reviewed Pear’s reSET-O product under the agency’s “breakthrough” medical devices program, which grants a faster review of technologies developed to address unmet medical needs for serious conditions.

The question is whether clinicians will prescribe it. Pear’s partner Sandoz, a division of pharma giant Novartis (NYSE: NVS), will lead the sales and marketing efforts for reSET-O. Sandoz began marketing Pear’s app for substance use disorder in November.

It’s early, but McCann says Pear’s app for opioid addiction has already received a “great deal of interest” from caregivers.

“Clinicians just don’t have enough resources to be able to take care of all the patients affected” by opioid addiction, McCann says. “When presented with data for clinical superiority, clinicians tend to be quite interested, whether the product is software, a drug, a device, or otherwise.”

In a 12-week, 170-patient, controlled clinical trial, use of the reSET-O software led to a statistically significant increase in patient retention—meaning the length of time that a patient sticks with the outpatient treatment program. That’s a crucial problem to address with patients suffering from opioid use disorder, where relapses are a chief concern, McCann says. (The company hasn’t studied whether the app can help prevent relapses after the outpatient program has ended.)

However, use of the Pear software during the trial was not shown to decrease illicit opioid use any more than buprenorphine and contingency management alone, according to the FDA. The app is not intended to be used as a standalone treatment, or to replace care by a doctor or other licensed medical practitioner.

Still, McCann is hopeful that the app will augment caregivers’ ability to treat patients and “allow patients to access care when they really need it—when they have cravings.” For example, if a patient wakes up in the middle of the night with a craving, their doctor might not be available, but they could open the app and access suggestions for how to deal with the craving, McCann says.