The US Food and Drug Administration (FDA) has cleared for marketing the first prescription mobile medical application to help treat substance use disorders (SUDs) involving alcohol, cocaine, marijuana, and stimulants, but not opioid dependence.
The reSET application, from Pear Therapeutics, should be used in conjunction with both outpatient therapy and a contingency management system, a widely used program for treating SUD that utilizes a series of incentives to reward patients for adherence to their treatment program, the FDA says.
The reSET mobile medical application system contains a patient application and clinician dashboard and incorporates cognitive-behavioral therapy, the FDA explained in a news release.
"This is an example of how innovative digital technologies can help provide patients access to additional tools during their treatment," Carlos Peña, PhD, director of the Division of Neurological and Physical Medicine Devices in the FDA's Center for Devices and Radiological Health, said in the release. "More therapy tools means a greater potential to help improve outcomes, including abstinence, for patients with substance use disorder."
In granting marketing approval for reSET, the FDA reviewed data from a multicenter, unblinded, 12-week clinical trial involving 399 patients who received either standard SUD 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 study showed a statistically significant increase in adherence to abstinence in patients with alcohol, cocaine, marijuana, and stimulant SUD who used reSET relative to those who did not (40.3% vs 17.6%). The study failed to demonstrate effectiveness of using the reSET device in patients who reported opioids as their substance of abuse.
The reSET system is indicated as a prescription-only adjunct treatment for patients with SUD who are not currently receiving opioid replacement therapy, who do not abuse alcohol solely, or whose primary substance of abuse is not opioids, the FDA says.
The reSET mobile medical application for SUD 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.