The new prescription digital therapeutic candidate is said to expand the company’s addiction franchise
Pear Therapeutics has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its reSET-A prescription digital therapeutic (PDT) product to treat alcohol use disorder (AUD).
The new prescription digital therapeutic candidate is said to expand the company’s addiction franchise, which consists of FDA-authorised products to treat substance use disorder (SUD) and opioid use disorder (OUD).
According to the company, AUD is a clinical diagnosis of alcoholism or alcohol addiction illustrated by an impaired ability to stop or control alcohol use regardless of adverse social, occupational, or health consequences.
Pear Therapeutics chief medical officer Yuri Maricich said: “We believe that PDTs can bring effective, evidence-based treatments for alcohol use disorder to many more people and in doing so help address the public health burden of AUD.
“We applaud FDA for recognizing the need to bring safe, effective, and innovative treatment options to patients and clinicians and we look forward to working closely with FDA under the Breakthrough Devices Program to gain marketing authorization of our AUD-only PDT product candidate.”
The reSET-A, which is the company’s AUD-only PDT product candidate, has not secured marketing authorisation from the FDA. It is also commercially not available in the US.
Earlier, the company secured FDA breakthrough device designation for reSET-O digital therapeutic to treat opioid use disorder.
By providing cognitive behavioural therapy as an adjunct to outpatient treatment, the reSET-O is used to increase retention of OUD patients in outpatient treatment.
The outpatient treatment consists of transmucosal buprenorphine and contingency management.
In June this year, Pear Therapeutics announced a merger with Thimble Point Acquisition, a special purpose acquisition company (SPAC), in a deal worth $1.6bn to go public.