Pear’s Digital Therapy for Alcohol Use Disorder Pays Off with Revolutionary FDA Label

With its proposed special purpose acquisition company just days away from shareholder approval, Pear Therapeutics is already preparing for its future as a publicly traded company.

After successfully leading three of his digital therapies through the FDA clearance process, Pear’s attention is now focused on bringing his next virtual treatment to market. The reSET-A program for alcohol use disorders joins the FDA approved reSET-O and reSET therapies for opioid use disorders and substance use disorders. wide, respectively, as well as its Somryst insomnia treatment application.

The chances of ReSET-A being cleared by the agency within the next year have increased, as Pear announcement this week the program received the revolutionary device designation from the FDA. The label removes some of the hurdles in the regulatory review process and gives Pear direct access to FDA advisors, speeding up the submission and review process.

Digital programs and digital devices earn the breakthrough title if the FDA determines that they could potentially meet a currently unmet medical need; according to Pear, if cleared by the regulator, reSET-A would become the first alcoholism-specific or digital therapy device to receive marketing authorization. Of the roughly 14 million American adults with alcohol use disorders, less than 1 in 10 are treated for the condition, according to survey data cited by Pear.

The designation of reSET-A comes approximately four years after reSET-O became the first digital prescription therapy, or PDT, to receive the FDA title. That milestone, in turn, came just a month after reSET – which is indicated to treat addiction to stimulants, cannabis, cocaine and alcohol – became the first PDT to gain approval from the ‘agency. The authorization of ReSET-O came a little over a year after its revolutionary designation.

RELATED: Digital Therapy Maker Pear Therapeutics Shakes Money Tree, With Plans To Go Public In $ 1.6 Billion PSPC Deal

ReSET-A is still in clinical trials as Pear prepares to put it on the FDA clearance path. Details on the program are scarce, but it likely reflects the company’s other PDTs for treating addiction.

ReSET and reSET-O are both three-month programs that use cognitive behavioral therapy to treat substance abuse. Patients take classes and track their substance use, cravings, triggers, symptoms and medication use in an app on their smartphone or tablet. This data, along with the results of urine tests and other clinical tests, is automatically shared with each patient’s healthcare team in a dashboard for physicians.

None of the drug addiction programs approved by Pear are meant to be stand-alone treatment. ReSET-O, for example, is indicated for prescription use in addition to transmucosal buprenorphine, emergency treatment, and regular clinical examinations.

RELATED: ICER Says More Data Needed On Digital Apps Treatments For Opioid Use Disorder

While the FDA clearly has confidence in the ability of Pear’s PDTs to provide effective and efficient long-term drug treatment, others are less convinced. Last year, the drug price watchdog ICER, the Institute for Clinical and Economic Review, questioned whether digital therapies represent an improvement over standard drug addiction treatments, and in particular opioid use disorders.

ICER’s analysis of reSET-O found that while the total cost of the application of $ 1,200 is acceptable for the three-month program, it may need to be discounted if its results are not. sustainable in the months and years following the end of the program.

In response to this report, Pear released its own data showing high engagement rates throughout the program, much of which took place outside of normal clinic hours, as well as improvements in drug testing outcomes. during the treatment period and a decrease in hospitalizations. up to six months after the end of reSET-O.

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