The Food and Drug Administration (FDA) has allowed marketing for the first-ever government-approved mobile medical app designed to help people with substance use disorders (SUD).
The San Francisco- and Boston-based app developer Pear Therapeutics created reSET, a digital app that focuses on outpatient therapy to aid against relapse from cocaine, stimulants, alcohol and marijuana use. However, the app is not yet designed to treat opioid addiction.
“It’s a prescription therapy so it will be available via prescription, and [patients] participate in a 90-day treatment course,” said Corey McCann, CEO of Pear Therapeutics.
The reSET app contains a patient application and a clinician dashboard. It provides cognitive behavioral therapy that teaches important skills used to continue treatment of a SUD, improve abstinence from drug use, and boost retention in outpatient programs.
The FDA analyzed data from a 12-week trial with nearly 400 patients who participated in standard addiction treatment or standard treatment alongside a desktop version of reSET. The results revealed a noticeable increase in sustained abstinence for those who used the app — 40.3 percent versus 17.6 percent, the government agency stated in a press release.
“I think if you roughly look at the size of the problem, we’re treating about 10 percent of the people that need treatment for SUD,” he said. “It’s a critical time for us to scale these types of products to bring [reSET] to all types of people.”
The federal agency emphasized the application’s use in conjunction with outpatient therapy and a contingency management system, which is a commonly used method to treat addiction that promotes adherence through a reward system.
The FDA noted that reSET does not currently assist people with only an alcohol dependence or those with a primary addiction to opioids.
“The clinical outcomes demonstrated in the reSET pivotal study are remarkable,” stated Dr. Edward Nunes, lead investigator on reSET’s clinical study, in a press release by Pear Therapeutics. “Clinically-validated digital therapeutics may become a cornerstone of future treatment.”
McCann said that the next step is to focus on bringing reSET into the hands of patients and clinicians. He hopes Pear Therapeutics will officially launch the product over the next six months.
The FDA’s approval “is really an amazing moment,” he said. “To put it into perspective, this the first time the FDA has approved something like this, especially in addiction treatment.”
Source: Cesar Gamboa, Addiction Now