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December 11, 2018

Sandoz and Pear Therapeutics get FDA clearance for reSET-O app

Novartis subsidiary Sandoz and Pear Therapeutics have obtained US Food and Drug Administration (FDA) 510(k) clearance for the use of the reSET-O mobile application, which treats opioid use disorder (OUD).

Novartis subsidiary Sandoz and Pear Therapeutics have obtained US Food and Drug Administration (FDA) 510(k) clearance for the use of the reSET-O mobile application, which treats opioid use disorder (OUD).

As a 12-week interval prescription digital therapeutic (PDT), reSET-O has been designed for patients aged 18 years and above who are under the supervision of a clinician.

The app is meant to increase retention of OUD patients in outpatient treatment by delivering cognitive behavioural therapy (CBT) adjunct to transmucosal buprenorphine and contingency management.

“In combination with outpatient treatment and contingency management, reSET-O was found to significantly improve retention in patients who previously received buprenorphine and contingency management.”

reSET-O delivers therapy in the form of a series of interactive therapy lessons comprising of a CBT component and skill-building exercises.

As part of the agreement signed between Sandoz and Pear Therapeutics in April this year, the former will lead marketing and commercialisation of reSET-O, which is scheduled to launch over the coming days.

Pear Therapeutics president and CEO Corey McCann said: “Nearly 50,000 drug overdose deaths involving opioids, including prescription pain medications and heroin, took place in the US in 2017. There is an urgent need for new and innovative therapeutics to address this public health epidemic.

“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.”

For the approval of reSET-O, the FDA reviewed data from a clinical trial that evaluated the digital therapeutic in 170 OUD patients over 12 weeks.

In combination with outpatient treatment and contingency management, reSET-O was found to significantly improve retention in patients who previously received buprenorphine and contingency management.

Sandoz CEO Richard Francis said: “New digital therapeutics such as reSET-O also have the potential to fundamentally change how patients interact with their therapies and thus improve patient outcomes.”

Last month, Sandoz and Pear Therapeutics commercially introduced another PDT product called reSET for patients with substance use disorder (SUD).

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