FDA Clears First Prescription-Based ‘Digital Therapeutic’
A new digital program called reSET has been cleared by the FDA as treatment for substance use disorders. reSET is a 12-week digital therapeutic meant to be used in conjunction with standard outpatient treatment for alcohol, cocaine, marijuana and stimulant SUD’s to improve treatment retention and abstinence.
“This is the first piece of software cleared by the FDA to treat any disease,” said Corey McCann, M.D., president and CEO of Pear Therapeutics.
The reSET app is only available to patients by prescription. Physicians can prescribe 90-day access to reSET in the form of a code that the patient enters after he or she downloads the app.
The primary support for reSET came from a multisite clinical study. At the study’s end, the patients with alcohol, cocaine, marijuana, and/or stimulant disorders who used reSET had a lower dropout rate and were about twice as likely to be abstinent.
“The pharma world is predicated on high-efficacy claims; their products have to show a definite level of superiority as a treatment,” McCann said. “We cleared this device using that same standard.”
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