The Food and Drug Administration has permitted marketing of the first mobile medical application aimed at helping to treat substance use disorders (SUDs) in adults, the agency announced Sept. 14.
“This is an example of how innovative digital technologies can help provide patients access to additional tools during their treatment,” said Carlos Peña, PhD, director of the division of neurological and physical medicine devices in the FDA’s Center for Devices and Radiological Health, in a statement.
“More therapy tools means a greater potential to help improve outcomes … for patients with substance use disorder,” Dr. Peña added.
The mobile medical application system, called reSET, is a prescription-only adjunct treatment to outpatient therapy lasting 12 weeks that contains a patient application and clinician dashboard. It delivers cognitive-behavioral therapy to patients by teaching them skills intended to encourage abstinence from substance abuse and to retain them in therapy. The reSET application is indicated as a treatment for patients aged 18 and older with SUD who are not on opioid replacement therapy and whose main substance of abuse is not opioids. It also is not indicated for patients who solely abuse alcohol.
The agency’s permission is based on data reviewed from a multisite, unblinded 12-week clinical trial sponsored by the National Institute on Drug Abuse of 399 patients who received either standard treatment or standard treatment with the addition of a desktop-based version of reSET. According to the data, adherence to abstinence for patients with alcohol, cocaine, marijuana, and stimulant SUD who used reSET increased 40.3%, compared with an increase of 17.6% in adherence to abstinence for patients who did not use the system.
No side effects are associated with the reSET application. Adverse events reported in clinical trials were in line with those found in patients with SUD, including cardiovascular disease, gastrointestinal events, depression, mania, suicidal behavior and ideation, and suicide attempts.
Edward V. Nunes, MD , said in a statement issued by the company that developed reSET, Pear Therapeutics, that the clinical outcomes found in the pivotal study were remarkable. “Clinically validated digital therapeutics may become a cornerstone of future treatment,” said Dr. Nunes, lead investigator in the study submitted to the FDA and a professor of psychiatry at Columbia University in New York.
For more information about the reSET medical application system, click here .
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