USA’s Food & Drug Administration has permitted marketing of the first mobile medical application to help treat substance use disorders (SUD). It is planned that the reSET application, to be marketed by Pear Therapeutics, will be used with outpatient therapy to treat alcohol, cocaine, marijuana and stimulant SUDs but will not treat opioid dependence.
The reSET device was reviewed through the de novo premarket review pathway, a regulatory pathway for some low to moderate-risk devices that are novel and for which there is no legally marketed predicate device to which the device can claim substantial equivalence.
Carlos Peña, Director of the Division of Neurological & Physical Medicine Devices at the FDA’s Centre for Devices & Radiological Health commented: “This is an example of how innovative digital technologies can help provide patients access to additional tools during their treatment.” Peña continued, “More therapy tools means a greater potential to help improve outcomes, including abstinence, for patients with substance use disorder.”
The reSET device is a mobile medical app containing a patient application and clinician dashboard. The device delivers cognitive behavioural therapy to patients to teach the user skills that aid in the treatment of SUD and are intended to increase abstinence from substance abuse and increase retention in outpatient therapy programmes.
The FDA reviewed data from a multi-site, unblinded 12-week clinical trial of 399 patients who received either standard treatment or standard treatment with the addition of a desktop-based version of reSET which could be accessed at the clinic or at home. The data showed a statistically significant increase in adherence to abstinence for the patients with alcohol, cocaine, marijuana and stimulant SUD in those who used reSET (40.3%) compared to the patients who did not (17.6%).
The reSET device is indicated as a prescription-only adjunct treatment for patients with SUD who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or whose primary substance of abuse is not opioids.