- FDA announced Monday that Pear Therapeutics' prescription-only mobile medical app, which aims to increase treatment retention for opioid use disorder (OUD) patients, has been granted 510(k) clearance.
- The reSET-O app, which will be jointly rolled out by Pear and Novartis subsidiary Sandoz within days, is designed to provide 12 weeks of cognitive behavioral therapy to patients who are also receiving a buprenorphine regimen and contingency management from a clinician.
- The clearance comes just weeks after the companies' reSET app for substance use disorder hit the market. The FDA nod is the latest sign the agency is embracing more digital health solutions, especially for overwhelming public health challenges like the opioid crisis.
Pear's reSET-O seeks to address a persistent challenge in the care of OUD patients: retention.
"There is an urgent need for new and innovative therapeutics to address this public health epidemic," Corey McCann, CEO of Pear Therapeutics, said in a press release. "This groundbreaking decision by the FDA ushers in a new standard for treating patients with Opioid Use Disorder and it signals a new path for therapeutic software to be used in conjunction with pharmacotherapy to improve efficacy."
Pear describes the app's services as lessons comprised of a cognitive behavioral therapy component and skill-building exercises delivered via a range of text, audio, videos, animations or graphics.
The 510(k) clearance is the latest action by FDA aimed at encouraging tech solutions to America's opioid crisis. The agency recently announced winners to an innovation challenge it launched for medtech companies to develop opioid abuse-fighting products.
"We know medication-assisted treatment works and we support novel ways to keep individuals more engaged in their treatment programs and to provide clinicians with new ways to intervene to help them remain in treatment," FDA Commissioner Scott Gottlieb said in a statement.
As part of its 510(k) application, a randomized clinical trial sponsored by the National Institute on Drug Abuse tested the therapeutic in 170 patients with opioid use disorder over 12 weeks, according to a statement from Pear. While reSET-O does not decrease illicit drug use or abstinence in OUD patients, the retention rates for patient care were statistically significant. Patients who used the reSET-O app in addition to having a regimen of clinician interaction and buprenorphine intake showed a retention rate of 82.4%, compared to a rate of 68.4% for patients who had the same treatment without using the app.
Pear and Sandoz announced in November that reSET, a similar app authorized in 2017 to treat substance use disorder, had hit the market. Last week, Pear announced clinical trial data for the OUD version of the product.
Pear said that Sandoz will lead the commercial launch of the product, similar to its role leading marketing for reSET.