Pear Therapeutics has secured US Food and Drug Administration (FDA) breakthrough device designation for its reSET-A prescription digital therapeutic (PDT) candidate, which is designed for the treatment of alcohol use disorder (AUD).
The product would expand Pear’s addiction portfolio, which currently includes PDTs for treating substance use disorder (SUD) and opioid use disorder (OUD).
Previously, Pear received FDA breakthrough device designation for reSET-O, indicated for treating OUD.
PDTs use software to directly treat a disease. These therapeutics are developed in a good manufacturing practise (GMP)-compliant environment, and subsequently, their safety and efficacy are evaluated in randomised controlled trials.
Pear chief medical officer Yuri Maricich said: “We believe that PDTs can bring effective, evidence-based treatments for AUD to many more people and in doing so help address the public health burden of AUD.
“We applaud FDA for recognising 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 programme to gain marketing authorisation of our AUD-only PDT product candidate.”
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AUD or alcoholism is characterised by an inability to stop or control alcohol drinking despite health or social consequences.
A national survey conducted in 2019 estimated that there are around 14 million adults in the US with AUD. Around 95,000 people die from alcohol-related causes in the US every year.
Currently, there are no FDA-authorised medical devices or PDTs dedicated to the treatment of AUD, and reSET-A is yet to receive marketing authorisation from the FDA.
Pear Therapeutics focuses on the development of PDTs. Earlier this year, the company entered a definitive business combination agreement with Thimble Point Acquisition to go public.