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FDA approves first substance use mobile medical application

Pear Therapeutics' Reset device offers cognitive behavioural therapy

US Food and Drug Administration (FDA)

US regulators have approved the first mobile medical application for substance use disorders involving alcohol, cocaine, marijuana and stimulants.

Pear Therapeutics’ Reset app offers cognitive behavioural therapy and is designed to be used alongside outpatient therapy and a widely-used SUD contingency management programme.

Reset works by teaching users skills to increase their abstinence from substance abuse and keep them in outpatient therapy programmes.

The FDA’s approval came on the back of a 12-week clinical trial involving 399 patients on either standard treatment or standard treatment plus a desktop version of Reset.

It showed a statistically significant increase (40.3% vs 17.6%) in adherence to abstinence for patients with alcohol, cocaine, marijuana and stimulant SUD who used Reset.

The trial did not demonstrate the effectiveness of using Reset for opioid abuse and the application is not licensed to treat opioid dependence.

Carlos Peña, director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said: “This is an example of how innovative digital technologies can help provide patients access to additional tools during their treatment.

“More therapy tools means a greater potential to help improve outcomes, including abstinence, for patients with substance use disorder.”

Reset contains a patient application and clinician dashboard and is indicated as a prescription-only adjunct treatment for patients with SUD who are not currently on opioid replacement therapy, do not abuse alcohol solely or whose primary substance of abuse is not opioids.

However, Pear’s development pipeline does include a version of the app specifically for opioid use disorder, alongside devices for use in areas such as schizophrenia, pain and major depressive disorder.

The Reset device was reviewed through the FDA’s de novo premarket review pathway for some low- to moderate-risk devices that are novel and for which there is no legally marketed equivalent.

US firm Pear noted the approval was the first time the FDA had cleared a prescription ‘digital therapeutic’ with claims to improve clinical outcomes in a disease.

Corey McCann, Pear’s president and CEO, said: “This is a defining moment for digital therapeutics and for patients with substance use disorder.

“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.”

US firm Pear noted the approval was the first time the FDA had cleared a prescription ‘digital therapeutic’ with claims to improve clinical outcomes in a disease.

Corey McCann, Pear’s president and CEO, said: “This is a defining moment for digital therapeutics and for patients with substance use disorder.

“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.”

Last year more than 20 million people in the US aged 12 or older needed treatment for a SUD related to alcohol or illicit drug use, with the problem thought to cost the country over $700m in health spending, crime and lost productivity.

15th September 2017

From: Regulatory

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