Press release

Pear Therapeutics Announces Publication of New Analysis of Real-World Data Showing Reduction in Insomnia Severity, Healthcare Resource Utilization and Associated Costs in Adults Using Somryst®

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Pear Therapeutics, Inc. (Nasdaq: PEAR), the leader in developing and commercializing software-based medicines called prescription digital therapeutics (PDTs), today announced the publication of new results from a health economic analysis of real-world data to evaluate healthcare resource utilization, associated costs and insomnia severity for Somryst® (previously known as SHUTi in its prior incarnation), the only FDA-authorized PDT for the treatment of chronic insomnia.

Results showed clinically meaningful reductions in health-related services and costs in the 24-months after Somryst initiation compared to 24-months prior. Further, clinically meaningful reductions in ISI were also found at end-of-treatment at nine weeks compared to baseline. The retrospective analysis was published in the international peer-reviewed journal ClinicoEconomics and Outcomes Research.1

“These real-world data underscore the potential clinical utility and durable economic benefit of a prescription digital therapeutic like Somryst among people with chronic insomnia,” said Yuri Maricich, M.D., Chief Medical Officer of Pear Therapeutics. “In the last 24 months, lack of sleep has been exacerbated by the ongoing COVID-19 pandemic and can greatly impact not only day-to-day activities, but also overall quality of life and long-term health. Now, it’s especially important to examine digitally delivered treatment options that can address the underlying issues of chronic insomnia.”

The analysis evaluated real-world data of 248 adult patients with chronic insomnia treated with Somryst over 24-months compared to the 24-months months prior to treatment and found:

  • Reductions in health-related services including:

    • Emergency department visits (53%; IRR: 0.47; 95% CI 0.27, 0.82; P=0.008).
    • Hospitalizations (21%; IRR: 0.79; 95% CI 0.46, 1.352; P=0.3887).
    • Hospital outpatient visits (13%; IRR: 0.87; 95% CI 0.66, 1.14; P=0.315).
    • Number of patients treated with sleep aid medications (18.5%)
  • An estimated $2,059 reduction in per-patient costs.1

Further, by end of treatment at nine weeks compared to baseline at treatment initiation, results found:

  • A 37.2% reduction in mean insomnia severity index (ISI) score (19.1 at baseline and 12.0 at nine weeks).
  • 58.9% of treated participants achieved ISI responder status (ISI score improved by >7).
  • 26.6% of treated participants achieved insomnia remission (ISI score <8) (0 at baseline and 66 at nine weeks).1

The full paper is available online by clicking here.

About Somryst®

Somryst is the only FDA-authorized therapeutic that delivers guideline recommended first-line treatment for chronic insomnia. Somryst is a 9-week prescription digital therapeutic (PDT) that addresses the underlying issues of chronic insomnia by delivering cognitive behavioral therapy for insomnia (CBTi), an evidence-based approach that trains the brain to sleep. The American Academy of Sleep Medicine and the American College of Physicians clinical guidelines recommend CBTi as first-line treatment for people with chronic insomnia.2,3 Somryst is used on a mobile device, such as a smartphone or tablet and is available by prescription only. A licensed Health Care Provider (HCP) must prescribe Somryst and use of Somryst should be undertaken only under the supervised care of an HCP.

Somryst Indications for Use and Important Safety Information

Somryst is a prescription-only digital therapeutic intended to provide a neurobehavioral intervention (Cognitive Behavioral Therapy for Insomnia – CBT-I) to patients 22 years of age and older with chronic insomnia. Somryst treats patients with chronic insomnia by improving a patient’s insomnia symptoms.

Safety Information and Warnings

Somryst is not for everyone. Please use your clinical judgment to determine whether Somryst is right for your patient.

  • Somryst is not for emergency use. Please instruct patients to dial 911 or to go to the nearest emergency room in the event of a medical emergency.
  • Patients should be clearly instructed not to use Somryst to communicate severe, critical, or urgent information to their Health Care Provider.
  • Somryst is not meant to be used as treatment without supervision of a Health Care Provider.
  • Somryst is not meant to be a substitution for any treatment medication.
  • Somryst contains sensitive medical information. Please instruct patients to protect their information by password-protecting their smartphone and tablet, ensuring no one else may access their device.
  • Sleep Restriction (and Consolidation) within Somryst can cause sleepiness, especially in the early stages of using the PDT. Somryst should not be used if the patient needs to be alert or cautious to avoid serious accidents in their job or daily life. Examples include:

    • Long-haul truck drivers
    • Long-distance bus drivers
    • Air traffic controllers
    • Operators of heavy machinery
    • Some assembly line jobs
    • The usage data collected in therapy lessons by Somryst are not intended to be used as a standalone assessment of treatment progress.

Note: In the early stages of treatment, increased daytime sleepiness may be expected, but it is usually temporary. Please instruct the patient to consult with their Health Care Provider if these experiences do not go away over a few weeks, as it may indicate that they have another sleep disorder or medical condition other than insomnia. Please instruct the patient that if they have trouble staying awake while performing potentially dangerous tasks (like driving) at any point in the treatment, to avoid these dangerous tasks or stop following the sleep restriction component of the therapy. This press release does not include all the information needed to use Somryst safely and effectively. Please see the full Clinician Brief Summary Instructions for Somryst for more information.

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.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the federal securities laws that are subject to risks and uncertainties and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements generally relate to future events involving, or future performance of, Pear. For example, statements that indicate clinical utility and durable economic benefit of patients using Somryst will improve are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “can” or variations of them or similar terminology.

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) the possibility that Pear may be adversely affected by other economic, business, regulatory, and/or competitive factors; (iii) the evolution of the markets in which Pear competes; (iv) the impact of the COVID-19 pandemic on Pear’s business; (v) changes in applicable laws or regulations; and (vi) other risks and uncertainties set forth in Pear’s filings with the SEC (including those described in the Risk Factors section). 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.

References:

  1. Forma F, Knight TG, Thorndike FP, Xiong X, Baik R, Velez FF, Maricich YA, Malone DC. Real-World Evaluation of Clinical Response and Long-Term Healthcare Resource Utilization Patterns Following Treatment with a Digital Therapeutic for Chronic Insomnia. Clinicoecon Outcomes Res. 2022;14:537-546 https://doi.org/10.2147/CEOR.S368780
  2. Schutte-Rodin S, Broch L, Buysse D, Dorsey C, Sateia M. Clinical guideline for the evaluation and management of chronic insomnia in adults. J Clin Sleep Med. 2008;4(5):487-504.
  3. Qaseem A, Kansagara D, Forciea MA, Cooke M, Denberg TD. Management of Chronic Insomnia Disorder in Adults: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2016; 165:125–133.