Pear Therapeutics Receives FDA Breakthrough Device Designation for Prescription Digital Therapeutic Candidate to Treat Alcohol Use Disorder

BOSTON--(BUSINESS WIRE)--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 expands Pear’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 treatment^2,3.

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.

About Prescription Digital Therapeutics (PDTs)
PDTs are a new therapeutic class that uses software to directly treat disease. Like traditional medicines, PDTs are developed in a GMP-compliant environment, tested in randomized controlled trials demonstrating safety and effectiveness, evaluated and authorized by regulators like FDA, and used under the supervision of a prescribing clinician^8,9. Unlike traditional medicines, PDTs are designed to collect real world data for use by prescribing clinicians and for population health management by payors and health systems.

About Pear Therapeutics
Pear Therapeutics is the leader in prescription digital therapeutics, or PDTs. Pear aims to redefine medicine by discovering, developing, and delivering clinically validated software-based therapeutics to provide better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers. Pear has a pipeline of products and product candidates across therapeutic areas, including the first three PDTs with disease treatment claims from the FDA. Pear’s lead product, reSET®, for the treatment of substance use disorder, was the first PDT to receive marketing authorization from FDA to treat disease. Pear’s second product, reSET-O®, for the treatment of opioid use disorder, was the first PDT to receive Breakthrough Designation. Pear’s third product, Somryst®, for the treatment of chronic insomnia, was the first PDT submitted through FDA’s traditional 510(k) pathway while simultaneously reviewed through FDA’s Software Precertification Pilot Program. For more information, visit Pear at www.peartherapeutics.com.

reSET-O Important Safety Information
Indications for Use
reSET-O is intended to increase retention of patients with Opioid Use Disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only prescription digital therapeutic.

Important Safety Information:
Warnings: reSET-O is intended for patients whose primary language is English with a reading level of 7th grade or above, and who have access to an Android/iOS tablet or smartphone. reSET-O is intended only for patients who own a smartphone and are familiar with use of smartphone apps (applications). Clinicians should not use reSET-O to communicate with their patients about emergency medical issues. Patients should be clearly instructed not to use reSET-O to communicate to their clinician any urgent or emergent information. In case of an emergency, patients should dial 911 or go to the nearest emergency room.

reSET-O is not intended to be used as a stand-alone therapy for Opioid Use Disorder (OUD). reSET-O does not replace care by a licensed medical practitioner and is not intended to reduce the frequency or duration of in-person therapy. reSET-O does not represent a substitution for a patient’s medication. Patients should continue to take their medications as directed by their healthcare provider.

Patients with opioid use disorder experience mental health disease and co-morbid medical problems at higher rates than the general population. Patients with opioid use disorder have higher baseline rates of suicidal ideation, and suicide attempts, and suicide completion. Clinicians should undertake standard of care to monitor patients for medical problems and mental health disease, including risk for harming others and/or themselves.

The long-term benefit of reSET-O has not been evaluated in studies lasting beyond 12 weeks (84 days) in the OUD population. The ability of reSET-O to prevent potential relapse after therapy discontinuation has not been studied.

This Press Release does not include all the information needed to use reSET-O safely and effectively. Please see the Clinician Brief Summary Instructions for reSET-O for more information.

1. National Institute on Alcohol Abuse and Alcoholism. (2021). Alcohol Facts and Statistics.
2. Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Behavioral Health Statistics and Quality. 2019 National Survey on Drug Use and Health. Table 5.4A—Alcohol Use Disorder in Past Year Among Persons Aged 12 or Older, by Age Group and Demographic Characteristics: Numbers in Thousands, 2018 and 2019. https://www.samhsa.gov/data/sites/default/files/reports/rpt29394/NSDUHDetailedTabs2019/NSDUHDetTabsSect5pe2019.htm?s=5.4&#tab5-4a. Accessed September 29, 2021.
3. https://www.psychiatry.org/newsroom/news-releases/apa-releases-new-practice-guideline-on-treatment-of-alcohol-use-disorder Accessed September 29, 2021.
4. Centers for Disease Control and Prevention (CDC). Alcohol and Public Health: Alcohol-Related Disease Impact (ARDI). Annual Average for United States 2011–2015 Alcohol-Attributable Deaths Due to Excessive Alcohol Use, All Ages. Available at: https://nccd.cdc.gov/DPH_ARDI. Accessed September 29, 2021 Methodology: According to CDC, due to scientific updates to ARDI, estimates of alcohol-attributable deaths or years of potential life lost generated in the current version of ARDI should not be compared with estimates that were generated using the ARDI default reports or analyses in the ARDI Custom Data Portal prior to July 30, 2020.
5. Peterson C, Li M, Xu L, Mikosz CA, Luo F. Assessment of Annual Cost of Substance Use Disorder in US Hospitals. JAMA Netw Open. 2021;4(3):e210242. doi:10.1001/jamanetworkopen.2021.0242.
6. reSET, Pear’s PDT, for patients with substance use disorder, includes in its labeled indications patients who use alcohol as well as other substances, such as cannabis, cocaine, or stimulants like methamphetamines
7. Han et al. 2021.
8. Campbell ANC, Nunes EV, Matthews AG, et al. Internet-delivered treatment for substance abuse: a multisite randomized controlled trial. Am J Psychiatry. 2014;171(6):683-690.
9. Christensen DR, Landes RD, Jackson L, et al. Adding an Internet-delivered treatment to an efficacious treatment package for opioid dependence. J Consult Clin Psychol. 2014;82(6):964-972. doi:10.1037/a0037496.