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FDA Clears Mobile App for Opioid Use Disorder

Man with smartphone

(Tero Vesalainen, Pixabay)

11 Dec. 2018. The Food and Drug Administration authorized a mobile app, when prescribed by clinicians for patients with opioid use disorder in outpatient treatment programs. The agency yesterday cleared the reSET-O app, developed by Pear Therapeutics Inc. in Boston, and marketed by the Sandoz division of drug maker Novartis, for sale in the U.S., the first mobile app authorized by FDA for opioid treatment.

The reSET-O app is designed for use with cognitive behavioral therapy in an outpatient setting to encourage participants with opioid use disorder to adhere to their treatment programs. Abuse of prescription opioid drugs, as well as heroin and fentanyl sold on the street, has become a serious national public health emergency, with overdose deaths from these drugs in 2018 numbering more than 115 per day, according to National Institute of Drug Abuse. A report by the National Academies of Sciences, Engineering, and Medicine in July 2017 spells out the full scope of the crisis beyond overdose deaths, with some 2 million Americans age 12 and older addicted to prescription opioid drugs and another 600,000 addicted to heroin.

The app can be downloaded and used only with a prescription from a licensed provider. It contains a 12-week program of cognitive behavioral therapy, a form of psychotherapy that seeks to change attitudes and behavior by concentrating on a person’s cognitive processes — thoughts, images, and beliefs — related to that individual’s behavior. Users of the app receive incentives and rewards for sticking with their therapy, also known as contingency management, while clinicians can track clients’ progress with a dashboard in a desktop software program.

FDA authorized the app when prescribed with buprenorphine as a replacement for prescription or street opioid drugs, and contingency management therapy. Buprenorphine is a partial opioid agonist that produces some euphoric effects, but also reduces cravings and physical dependency, thus lowering withdrawal symptoms and the risk of overdose.

The agency cleared reSET-O based in part on results of a clinical trial with 170 patients in an outpatient program using both buprenorphine and contingency management. Participants in the trial were randomly assigned to use the desktop version of reSET-O or receive the conventional therapy without the app. The results show more than 8 in 10 (82%) of individuals using reSET-O remained in their treatment programs, compared to about two-thirds (68%) receiving buprenorphine and contingency management alone. Pear Therapeutics presented findings from the trial last week at a meeting of the the American Academy of Addiction Psychiatry.

As reported by Science & Enterprise, FDA in September 2017 authorized Pear Therapeutics’ reSET app to aid outpatient therapy for abuse of alcohol, cocaine, marijuana, and stimulants. It was the first mobile app cleared by the agency for substance abuse of any kind. However, the basic reSET app was not authorized for opioid use programs. In July 2017, the company received an NIH small business grant to develop and test reSET-O specifically for opioid use disorder.

“Often on the road to recovery, patients find their commitment to staying in treatment may wane,” says FDA Commissioner Scott Gottlieb in an agency 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.”

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