FDA permits first digital therapeutic device for treatment of substance use disorders

The United States Food and Drug Administration (US FDA) yesterday – 14th of September 2017, permitted the marketing of an application developed for mobiles that would help in the treatment of substance use disorders (SUD).

This ReSET® application would be used on an outpatient basis for the management of various substance use problems such as those with alcohol, marijuana or cocaine and other stimulant addictions. It is not useful in opioid dependence however.

reSET® for Substance Use Disorder. Image Credit: Pear Therapeutics, Inc.
reSET® for Substance Use Disorder. Image Credit: Pear Therapeutics, Inc.

According to Carlos Peña, the director of the Division of Neurological and Physical Medicine Devices in FDA’s Center for Devices and Radiological Health, this new innovation goes to show how digital technologies can help patients with their treatment. Peña added that similar tools would help these patients with SUD abstain better and help better the outcomes of the treatment.

This new ReSET® device is a mobile medical application system that has two dashboards – one each for the patient and the clinician. The device would provide cognitive behavioral therapy or CBT to patients that would encourage them to improve their abstinence from the addictive substances as well as improve their adherence to the outpatient treatment programme. Just like abstinence is a problem in persons with SUD, adherence to treatment programs is another challenge.

The device provides both the patients and the clinician access to triggers, cravings as well as substance use. This system would be used alongside outpatient therapy and contingency management system. Contingency management system is used widely in patients with SUD and comprises of a reward system that helps patients stick to their treatment schedules.

The new device by Pear Technologies was tried on 399 patients in a 12 week clinical trial. The patients were divided into two arms – one group received standard treatment for SUD and the other arm or group received both standard treatment and desktop version of the ReSET® device treatment that was accessible either at home or at the clinic. The study was a multi-site (meaning more than one medical centre was involved) and unblended trial (meaning both the clinician administering the device and the patients with SUD in the device arm knew that they were being treated with an experimental therapy).

Results of the trial showed that in the group that used the ReSET® device, there was an increased tendency to stick to the treatment program compared to those who received only standard therapy. Numbers revealed that 40.3 percent persons with dependence problems with alcohol, cocaine, stimulants or marijuana treated with ReSET® adhered to their treatment programmes while only 17.7 percent of those treated with standard therapy alone adhered to the programmes. Those with opioid dependence did not show benefits with the additional use of ReSET®.

Based on this trial results, the FDA has permitted the device as of now to be used only in conjunction with standard treatment and only on prescription. It is not to be used in patients who have an alcohol dependence only. It is also not to be used in patients who have an opioid dependence or those who are on opioid replacement therapy (a standard modality of treatment for opioid dependence).

The device was deemed to be of low to moderate risk to the users by the reviewers with no adverse effects noted in the clinical studies. Patients were evaluated for side effects such as heart disease, gastrointestinal problems, mania, depression, suicidal tendencies and attempts etc. It is a novel device that has no equivalent device. The marketing of the reSET® device as of now has been granted by the FDA to Pear Therapeutics.

This is the first prescription digital therapeutic device to get the FDA nod. According to Corey McCann, President and Chief Executive Officer of Pear Therapeutics this is a “defining moment” for patients with SUD as well as for digital therapeutics.

Substance Use Disorders (SUD)

Substance use disorders or SUD is defined as a condition by the Substance Abuse and Mental Health Services Administration as recurrent use of alcohol and or drugs by a person that can cause functional and clinically significant impairment of the patients leading to problems at work, home or school and also leads to disabilities and health problems. It is defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition – DSM-V (the manual for mental health related problems) SUD refers to social impairment and lack of control, risky usage of the abused drugs and also for diagnosis needs to meet certain pharmacological criteria.

According to a 2016 estimate, nearly 20.1 million persons over 12 had SUD with alcohol and illegal drugs. These addictions cost the economy over $700 billion a year not only in terms of healthcare provision but also loss of productive work and crime related losses. SUD kills over 90,000 Americans each year.

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