BOSTON--(BUSINESS WIRE)-- Pear Therapeutics, Inc. (Nasdaq: PEAR), the leader in developing and commercializing software-based medicines called prescription digital therapeutics (PDTs), today announced the expansion of its program to offer patients seeking treatment for addiction access to a telehealth provider through its “find a provider tool”, along with in-person care options. Pear’s second telehealth offering in this program will offer eligible patients with opioid use disorder (OUD), who prefer a telemedicine solution, access to reSET-O through QuickMD, a telemedicine platform providing consultations and urgent care over phone and video.

According to new data released by the U.S. Centers for Disease Control and Prevention, America’s addiction crisis is the deadliest it has ever been with overdose deaths reaching an all-time high in 2021.^1,2 Throughout the Covid-19 pandemic, telemedicine and PDTs have helped in providing patients with 24/7 access and care. The number of people who used telemedicine doubled from 39.4% to 79.5% in 2020.³ Innovative treatment options like reSET-O can help to address the ongoing opioid epidemic by reaching patients where they are and to reduce the stigma often associated with opioid addiction.

“We are proud to be able to offer compassionate care to patients suffering from OUD through our team of dedicated doctors and with recovery tools such as reSET-O that complement medication-assisted treatment,” said Jared Sheehan, Chief Operating Officer at QuickMD. “QuickMD works to offer treatment options to our patients that provide security and privacy in a telemedicine environment, all from the privacy of a patient’s home.”

“Pear is pleased to work with telehealth providers in providing innovative, FDA-authorized treatments that enable round-the-clock access to assist eligible patients in their recovery journey during these difficult times,” said Julia Strandberg, Chief Commercial Officer at Pear Therapeutics. “After so many uncertain months, it is important to meet people where they are and where they feel comfortable, providing them with access to the care they need.”

Pear’s reSET-O, for the treatment of OUD, has been measured in real-world use and its therapeutic content studied in randomized controlled trials, with results published in peer-reviewed medical journals^4,5. reSET-O, which is adjunctive to outpatient counselling, provides patients with cognitive behavioral therapy, fluency training, and contingency management, while clinicians receive access to clinical dashboards to inform in-office and tele visits.

About Pear Therapeutics

Pear Therapeutics, Inc., which is traded on Nasdaq as PEAR, is the parent company of Pear Therapeutics (US), Inc. Pear is the leader in developing and commercializing software-based medicines, called prescription digital therapeutics (PDTs). Pear aims to redefine care through the widespread use of 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 the first end-to-end platform to discover, develop, and deliver PDTs to patients and a pipeline of products and product candidates across therapeutic areas, including the first three PDTs with disease treatment claims from the FDA. Pear’s product, reSET^®, for the treatment of substance use disorder, was the first PDT to receive marketing authorization from the 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.

Forward-Looking Statements from Pear Therapeutics

Certain statements and projections in this press release may be considered forward-looking statements within the meaning of the federal securities laws. Forward looking statements generally relate to future events or involving, or future performance of, Pear. For example, statements regarding round-the-clock access to, and the continued availability of, the QuickMD telehealth platform are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “will”, “aim”, “estimate”, “anticipate”, “believe”, or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward looking statements.

These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Pear and its management are inherently uncertain. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (i) delay or reluctance by patients and/or providers to adopt, request or use Pear’s products, (ii) whether Pear’s initiative in telehealth with QuickMD or other telehealth providers will be successful, (iii) changes in applicable laws or regulations; and (iv) other risks and uncertainties set forth in Pear’s future filings with the SEC. These filings will identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements.

Readers are cautioned not to put undue reliance on forward-looking statements, and Pear assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Pear gives no assurance that Pear will achieve its expectations. The inclusion of any statement in this communication does not constitute an admission by Pear or any other person that the events or circumstances described in such statement are material.

References:

1. https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm.
2. https://www.upi.com/Health_News/2022/05/11/drug-overdose-deaths-2021-CDC/1521652274564/
3. https://azbigmedia.com/business/future-of-telehealth-is-brighter-than-ever-in-the-wake-of-covid-19/
4. 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.
5. 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.

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