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Pear Therapeutics, Inc., the leader in developing and commercializing software-based medicines called prescription digital therapeutics (PDTs), today announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its reSET-A™ PDT product candidate designed for the treatment of alcohol use disorder (AUD). reSET-A potentially expandsPear's addiction franchise, which includes FDA-authorized products to treat substance use disorder (SUD) and opioid use disorder (OUD). This is the second such Breakthrough Device Designation received by Pear, following the designation awarded for reSET-O®, the first ever for a PDT, which was for the treatment of OUD.
Alcohol is one of the most commonly used substances in the United States. AUD is a clinical diagnosis of alcoholism, or alcohol addiction characterized by an impaired ability to stop or control alcohol use despite adverse social, occupational, or health consequences1. According to a national survey, approximately 14 million adults ages 18 and older in the U.S. had AUD in 2019 with fewer than one in 10 individuals with a 12-month diagnosis of AUD receiving any treatment2,3.
Each year, an estimated 95,000 people die from alcohol-related causes, making alcohol the third-leading preventable cause of death in the United States4 with an estimated total annual medical cost in hospitals of $7.6 billion5. Today, there are few treatment options for patients with AUD with less than 2% of patients with AUD receiving medication for treating AUD6. In the U.S. today, there are no FDA-authorized medical devices or PDTs indicated for people suffering from AUD-only7.
"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," said Yuri Maricich, Pear's Chief Medical Officer. "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 Breakthrough Devices Program is intended for devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The program is designed to expedite development of the device and the prioritized review of the subsequent regulatory submissions, although there is no assurance that any of these benefits may be experienced. It is available for devices, like PDTs, which may be subject to FDA review under a premarket approval (PMA) application, premarket notification (510(k)), or De Novo classification request.
Pear's AUD-only PDT product candidate, reSET-A, has not received marketing authorization from FDA and is not available for sale in the United States.
Posted In: THMA
