Pear scores Breakthrough Device Designation for digital therapeutic aimed at alcohol use disorder

Pear Therapeutics introduced Monday it had obtained Breakthrough Gadget Designation from the FDA for its prescription digital therapeutic aimed toward treating alcohol use dysfunction, reSET-A.

The information comes simply forward of the corporate’s planned merger with a special purpose acquisition company, Thimble Point Acquisition Corp., which can enable it to commerce publicly. Pear already has FDA-cleared digital therapeutics for substance abuse disorder, opioid use disorder and chronic insomnia

The Breakthrough Device Designation isn’t a advertising and marketing approval from the FDA, however it goals to speed up evaluation of merchandise that would assist deal with debilitating or life-threatening situations. 

“We imagine that PDTs can convey efficient, evidence-based remedies for alcohol use dysfunction to many extra individuals and in doing so assist handle the general public well being burden of AUD,” Yuri Maricich, Pear’s chief medical officer, mentioned in a press release.

“We applaud FDA for recognizing the necessity to convey secure, efficient and revolutionary therapy choices to sufferers and clinicians and we sit up for working intently with FDA underneath the Breakthrough Gadgets Program to achieve advertising and marketing authorization of our AUD-only PDT product candidate.”

WHY IT MATTERS

Practically 15 million individuals within the U.S. ages 12 and over had alcohol use dysfunction in 2019, according to the National Survey on Drug Use and Health. However solely 7.2% of these with AUD had obtained any therapy. 

In the meantime the CDC estimates more than 95,000 people die annually from alcohol-related causes. 

THE LARGER TREND

Final week, Pear announced it had secured up to $50 million in further capital as a part of the non-public funding in public fairness funding, or PIPE, that’s raised alongside the SPAC merger. A shareholder assembly to vote on the mix is scheduled for subsequent week. 

The corporate had revealed its plans to go public by way of a SPAC – an more and more fashionable method for digital well being corporations to make a public exit – in June this year.

In October, Pear introduced that Massachusetts’ Medicaid program, MassHealth, deliberate to cowl its prescription digital therapeutics for treating substance and opioid use problems, reSET and reSET-O.

The corporate has a variety of therapeutics in its pipeline. reSET for substance use dysfunction obtained FDA De Novo clearance in 2017; reSET-O for opioid use was Pear’s second therapeutic to get the FDA nod in 2018; and Somryst for insomnia received marketing authorization in 2020

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