FDA Clears mHealth App reSET-O for Opioid Addiction

Today the U.S. Food and Drug Administration (FDA) granted clearance for reSET-O, a digital therapeutic app created by Sandoz, a division of Novartis, and Pear Therapeutics.

The mobile health (mHealth) app is intended to increase the retention of those with opioid use disorder in outpatient treatment. The app provides cognitive behavioral therapy to complement outpatient therapy that includes transmucosal buprenorphine (medication-assisted-treatment) and contingency management for adult patients who are under the supervision of a clinician. It is a prescription-only mHealth app.

>> READ: After FDA Approval, Pear Therapeutics Releases Drug Treatment mHealth App reSET

“New digital therapeutics such as reSET-O also have the potential to fundamentally change how patients interact with their therapies and thus improve patient outcomes,” Richard Francis, CEO of Sandoz, said in a statement.

A 12-week interval prescription digital therapeutic, reSET-O delivers community reinforcement approach therapy through interactive therapy lessons. Lessons combine cognitive behavioral therapy and skill-building exercises delivered through text or audio.

Patients can use the app to self-report cravings, triggers and use or non-use of buprenorphine to their clinician between visits.

“Medical devices, including digital health devices like mobile medical apps, have the potential to play a unique and important role in contributing to these treatment efforts,” FDA Commissioner Scott Gottlieb, M.D., said in a statement.

The National Institute on Drug Abuse sponsored a clinical trial of 170 patients with opioid use disorder over 12 weeks to test the mHealth app. Patients either received normal treatment consisting of standard clinician visits and buprenorphine or reSET-O cognitive behavioral therapy with standard clinician visits and buprenorphine.

The study found that those who used reSET-O cognitive behavioral therapy along with outpatient treatment and contingency management significantly improved retention compared to patients with the standard treatment. Treatment dropout was reduced in the test group.

According to president and CEO of Pear Therapeutics, Corey McCann, M.D., Ph.D., almost 50,000 drug overdose deaths involving opioids, including prescription medications and heroin, took place in the U.S. last year.

Approximately 115 Americans die each day after overdosing on opioids. More than 80 percent of patients with opioid use disorder do not receive care and only 13 percent of outpatient facilities in the U.S. offer medication-assisted-treatment.

“reSET-O could have the potential to dramatically impact this gap in treatment, by delivering multi-modal therapy in combination with [medication-assisted-treatment] in a way that is designed to be more effective, convenient and easy to access for patients and clinicians,” the release said.

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