- Interim results from the DREAM trial showed treatment with Somryst, a prescription digital therapeutic (PDT) for patients with chronic insomnia, achieved significant reductions in symptoms of insomnia, anxiety and depression severity through six months1
- New real-world data are consistent with the clinical effects previously observed in pivotal clinical trials for Somryst, the only FDA-authorized PDT to treat chronic insomnia
Pear Therapeutics, Inc. (Nasdaq: PEAR), the leader in developing and commercializing software-based medicines called prescription digital therapeutics (PDTs), today announced interim follow-up real-world data from DREAM, a remote, decentralized trial, that showed treatment with Somryst®, the only FDA-authorized PDT for the treatment of chronic insomnia, achieved significant reductions in symptoms of insomnia, anxiety and depression severity both immediately following treatment and six months later.1 The results were presented as a late-breaking poster at the 36th Annual Meeting of the Associated Professional Sleep Societies (APSS), known as “SLEEP 2022,” held June 4-8, 2022 in Charlotte, North Carolina.
“Chronic insomnia is often associated with depression and anxiety so it’s important to evaluate the impact of insomnia treatment on such psychiatric comorbidities. We seek to measure not only impact on nighttime sleep but also effect on daytime impairment,” said Yuri Maricich, MD, MBA, Chief Medical Officer and Head of Development, Pear Therapeutics. “We’re encouraged by the durable response seen in this interim real-world analysis of cognitive behavioral therapy for insomnia delivered by Somryst and look forward to seeing additional data from the DREAM trial.”
Interim data from the DREAM study (NCT04325464), a remote, virtual, open-label, decentralized clinical trial evaluating Somryst, analyzed in mid-Q1 2022, included 993 adult patients (22-75 years of age) enrolled to date with chronic insomnia living in the U.S. who had access to a mobile device. Data cutoff for this interim analysis was January 20, 2022. Results found that patients treated with Somryst for nine weeks with digitally delivered first-line guideline recommended cognitive behavioral therapy for insomnia (CBT-I) was associated with a significant decrease in the symptoms of insomnia severity both immediately following treatment and six months later. Additionally, scores of depression and anxiety decreased significantly both immediately following treatment and at 6-month follow-up, with the largest observed decreases in Generalized Anxiety Disorder (GAD-7) and Patient Health Questionnaire depression scale (PHQ-8) scores among people with more severe symptoms.1
Specifically, interim data showed participants treated with Somryst experienced the below improvements:
- Insomnia Severity Index (ISI) score: The ISI score at baseline among those with severe insomnia was 23.9, at end of treatment (EOT) was found to be 14.5, and at 6 months 16.7 (p < 0.0001). ISI is scored on a 0-28 scale. 1
- PHQ-8: The PHQ-8 score, a 0-24 scaled measure of depression severity, at baseline among those with severe depression was 21.4, at EOT was found to be 12.7, and at 6 months 12.3 (Cohen’s d = 0.96-1.51 for moderate to severe depression) (p<0.001), where Cohen’s effect sizes over 1.0 are also considered large treatment effects.1
- GAD-7 scale: The GAD-7 score, a 0-21 scaled measure of anxiety severity, at baseline among those with severe anxiety was 17.6, and at EOT and at 6 months was found to be 10.8 (Cohen’s d = 1.43-1.55 for severe anxiety) (p<0.001).1
As part of its PearCreate™ platform, Pear has developed its own remote, decentralized, virtual clinical trial infrastructure for participant recruitment, screening, consent, enrollment, follow up, and progress tracking, which was used for the DREAM study.
These results are interim and additional results will be reported on in the future, upon completion of enrollment and patients reaching subsequent follow-up assessment periods.
For more information and to view the presentation, please visit https://www.sleepmeeting.org/.
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 judgement 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 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.
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 patients using Somryst will experience significant reductions in insomnia, anxiety and depression severity through 9 week and 6 months’ usage 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.
- Morin C, Thorndike FP, Ojile JM, Gerwien R, Wendorf A & Maricich Y (2022). Effects of a Digital CBT-I Therapeutic in Improving Sleep and Reducing Anxiety and Depression Symptoms in Adults With Chronic Insomnia: Interim Analysis of DREAM Study. Poster # 331. SLEEP 2022, the 36th Annual Meeting of the Associated Professional Sleep Societies (APSS), 2022.
- 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.
- 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.