Pear's digital therapeutic for alcohol use disorder bears fruit with FDA breakthrough tag

person holding smartphone
ReSET-A offers cognitive behavioral therapy to treat alcohol addiction, joining Pear Therapeutics’ other digital treatments for both opioid use disorder and the broader category of substance use disorder. (Getty Images)

With its proposed special purpose acquisition company deal only days away from shareholder approval, Pear Therapeutics is already plotting out its future as a publicly traded company.

After successfully carrying three of its digital therapeutics through the FDA authorization process, Pear’s attention is now focused on bringing its next virtual treatment to the market. The reSET-A program for alcohol use disorder joins the FDA-cleared reSET-O and reSET therapies for opioid use disorder and broader substance use disorder, respectively, as well as its Somryst insomnia treatment app.

ReSET-A’s odds of being cleared by the agency in the next year or so just got higher, as Pear announced this week that the program has received the FDA’s breakthrough device designation. The label clears some of the obstacles from the regulatory review pathway and gives Pear direct access to FDA advisers, speeding up the submission and evaluation process.

Digital programs and digital devices earn the breakthrough title if the FDA determines they could potentially address a currently unmet need in medicine; according to Pear, if cleared by the regulator, reSET-A would become the first alcoholism-specific device or digital therapeutic to receive market authorization. Of the approximately 14 million American adults with alcohol use disorder, fewer than 1 in 10 are treated for the condition, according to survey data cited by Pear.

The designation for reSET-A comes about four years after reSET-O became the first prescription digital therapeutic, or PDT, to receive the title from the FDA. That milestone, in turn, came just one month after reSET—which is indicated to treat dependence on stimulants, cannabis, cocaine and alcohol—became the first PDT to garner the agency’s approval. ReSET-O’s authorization came just over a year after its breakthrough designation.

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ReSET-A is still undergoing clinical trials as Pear prepares to usher it through the FDA authorization pathway. Details about the program are scarce, but it likely mirrors the company’s other PDTs to treat addiction.

Both reSET and reSET-O are three-month programs that use cognitive behavioral therapy to treat addiction. Patients complete lessons and track their substance use, cravings, triggers, symptoms and medication use in an app on their smartphone or tablet. Those data, plus results of urine and other clinical tests, are automatically shared with each patient’s care team in an accompanying physician-facing dashboard.

Neither of Pear’s approved addiction programs are meant to be standalone treatments. ReSET-O, for example, is indicated for prescription use alongside transmucosal buprenorphine, contingency management therapy and regular clinician checkups.

RELATED: ICER says more data are needed on digital app treatments for opioid use disorder

Though the FDA evidently has faith in the ability of Pear’s PDTs to offer effective and efficient long-term addiction treatment, others are less convinced. Last year, drug pricing watchdog ICER, the Institute for Clinical and Economic Review, cast doubt on whether digital therapeutics represent an improvement over standard treatments for addiction, and specifically opioid use disorder.

ICER’s analysis of reSET-O found that while the app’s total cost of $1,200 is acceptable for the three-month program, it may need to be discounted if its results aren’t sustainable in the months and years after the program is completed.

In response to that report, Pear released data of its own showing high rates of engagement throughout the entire program—much of which took place outside of normal clinic hours—as well as improvements in drug screening results during the treatment period and a drop in hospitalizations for up to six months after completion of reSET-O.