BOSTON – (BUSINESS WIRE) – Pear Therapeutics, the leader in the development and commercialization of software-based drugs called Digital Prescription Therapies (PDTs), today announced it has been awarded the Food Breakthrough Device designation and Drug Administration (FDA) for its product candidate reSET-A ™ PDT for the treatment of alcohol use disorder (AUD). reSET-A potentially expands Pear’s addiction franchise, which includes products approved by the FDA to treat substance use disorders (SUD) and opioid use disorders (OUD). This is the second revolutionary device designation of its kind received by Pear, following the designation given for reSET-O®, the very first for a PDT, which was intended 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 dependence characterized by a reduced ability to stop or control alcohol consumption despite adverse social, occupational or health consequences.1. According to a national survey, approximately 14 million adults aged 18 and over in the United States had AUD in 2019, with less than one in 10 people with a 12-month diagnosis of AUD receiving treatment.2.3.
Each year, an estimated 95,000 people die from alcohol-related causes, making alcohol the third 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 AUD patients, with less than 2% of AUD patients receiving drugs to treat AUD.6. In the United States today, there are no FDA-approved medical devices or PDTs indicated for people with AUD only.7.
“We believe PDT can bring effective, evidence-based treatments for alcohol use disorders to more people and in so doing help reduce the public health burden of AUD. Said Yuri Maricich, medical director of Pear. “We commend the FDA for recognizing the need to provide safe, effective and innovative treatment options to patients and clinicians, and we look forward to working closely with the FDA on the Breakthrough Devices program to achieve the Marketing authorization for our product candidate PDT in AUD only. “
The Breakthrough Devices program is for devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The program is designed to expedite device development and priority review of subsequent regulatory submissions, although there is no assurance that any of these benefits can be felt. It is available for devices, such as PDTs, which may be subject to FDA review as part of an application for pre-market approval (PMA), pre-market notification (510 (k)) or a De Novo classification request.
Pear’s AUD-only PDT product candidate, reSET-A, has not received marketing authorization from the FDA and is not available for sale in the United States.
About Prescription Digital Therapeutics (PDT)
PDTs are a new class of therapy that uses software to directly treat the disease. Like traditional medicines, PDTs are developed in a GMP-compliant environment, tested in randomized controlled trials demonstrating safety and efficacy, evaluated and cleared by regulators like the 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 the management of population health by payers and health systems.
About Pear Therapeutics
Pear Therapeutics is the leader in digital prescription therapies, or PDTs. Pear aims to redefine medicine by discovering, developing and delivering clinically validated software therapies to deliver better patient outcomes, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers. Pear has a pipeline of product and product candidates across all therapeutic areas, including the top three PDTs with FDA disease treatment claims. Pear’s flagship product, reSET®, for the treatment of substance use disorders, was the first PDT to receive market authorization from the FDA to treat the disease. Pear’s second product, reSET-O®, for the treatment of opioid use disorders, was the first PDT to receive the breakthrough designation. Pear’s third product, Somryst®, for the treatment of chronic insomnia, was the first PDT submitted via the traditional 510 (k) route to the FDA while simultaneously being reviewed under the pilot software pre-certification program of the FDA. For more information, visit Pear at www.peartherapeutics.com.
reSET-O Important safety information
Indications for use
reSET-O is intended to increase the retention of patients with opioid use disorder (ODD) in outpatient treatment by providing cognitive behavioral therapy, in addition to outpatient treatment which includes transmucosal buprenorphine and contingency management, for patients 18 years of age or older who are currently under the supervision of a clinician. reSET-O is indicated as a digital prescription therapy only.
Important safety information:
Warnings: reSET-O is intended for patients whose primary language is English with a reading level of grade 7 or above, and who have access to an Android / iOS tablet or smartphone. reSET-O is intended only for patients who have a smartphone and are familiar with the use of smartphone applications (apps). 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 any urgent or emerging information to their clinician. In 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 is not a substitute for treatment by a licensed physician and is not intended to reduce the frequency or duration of in-person therapy. reSET-O is not a substitution for a patient’s medication. Patients should continue to take their medications as directed by their health care provider.
Patients with opioid use disorders experience co-morbid mental illnesses and medical conditions at higher rates than the general population. Patients with opioid use disorders have higher baseline rates of suicidal ideation, suicide attempts, and suicide completion. Clinicians should apply standards of care to monitor patients for medical problems and mental illnesses, including the risk of harming others and / or themselves.
The long-term benefit of reSET-O has not been evaluated in studies longer than 12 weeks (84 days) in the OUD population. The ability of reSET-O to prevent a potential relapse after discontinuation of treatment has not been studied.
This press release does not include all of the information necessary to use reSET-O safely and effectively. Please see the summary of clinician instructions for reSET-O for more information.
- National Institute on Alcohol Abuse and Alcoholism. (2021). Alcohol facts and statistics.
- Addiction 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 the Past Year Among People Aged 12 Years and Over, 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.
- https://www.psychiatry.org/newsroom/news-releases/apa-releases-new-practice-guideline-on-treatment-of-alcohol-use-disorder Accessed September 29, 2021.
- Centers for Disease Control and Prevention (CDC). Alcohol and Public Health: Impact of Alcohol-Related Diseases (ARDI). Annual average for the United States 2011-2015 Alcohol-attributable deaths due to excessive alcohol consumption, all ages. Available at: https://nccd.cdc.gov/DPH_ARDI. Accessed September 29, 2021 Methodology: According to the CDC, due to scientific updates from ARDI, estimates of alcohol-attributable deaths or potential years of life lost generated in the current version of ARDI should not be not be compared to estimates generated using the default ARDI value. reports or analyzes in the ARDI personalized data portal before July 30, 2020.
- Peterson C, Li M, Xu L, Mikosz CA, Luo F. Estimating the Annual Cost of Substance Use Disorders in US Hospitals. JAMA Netw Open. 2021; 4 (3): e210242. doi: 10.1001 / jamanetworkopen.2021.0242.
- reSET, Pear’s PDT, for patients with substance use disorders, includes in its labeled indications patients who consume alcohol as well as other substances, such as cannabis, cocaine or stimulants such as methamphetamines
- Han et al. 2021.
- Campbell ANC, Nunes EV, Matthews AG, et al. Internet-Provided Treatment for Substance Abuse: A Multisite Randomized Controlled Trial. Am J Psychiatry. 2014; 171 (6): 683-690.
- Christensen DR, Landes RD, Jackson L, et al. Adding Internet-Provided Treatment to an Effective Treatment Package for Opioid Dependence. J Consult Clin Psychol. 2014; 82 (6): 964-972. doi: 10.1037 / a0037496.