PDTs use software to directly treat a disease. Credit: Pexels / Pixabay.

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).

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.