BOSTON & SAN FRANCISCO--(BUSINESS WIRE)--Pear Therapeutics, Inc. today announced the U.S. Food and Drug Administration (FDA) has granted authorization for Somryst™, the first prescription digital therapeutic (PDT) intended for use in the treatment of patients 22 years of age and older with chronic insomnia. Somryst treats patients with chronic insomnia by improving a patient’s insomnia symptoms. Somryst is the first product submitted through FDA’s traditional 510(k) pathway while simultaneously reviewed as part of FDA’s Software Precertification Pilot Program to help build and test FDA’s Digital Health Precertification Working Model 1.0 [1].

Somryst is intended to provide tailored neurobehavioral interventions, specifically Cognitive Behavioral Therapy for insomnia (CBTi) and sleep restriction driven by algorithms designed to improve the symptoms of insomnia. Somryst includes features that allow for personalization including the patient’s ability to set a sleep window. 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 the only FDA-authorized therapeutic that delivers guideline recommended first-line treatment for chronic insomnia.

“More than 30 million adults suffer from chronic insomnia, which can seriously impact one’s quality of life and can lead to depression, suicidality, hypertension and even heart attacks. Treatment options for chronic insomnia are limited as most available sleep medications are only recommended for short term use, can lead to problems with tolerance, and can have unwanted side-effects, including next-day cognitive impairments,” said Dr. Charles M. Morin, PhD, Professor of Psychology, Director Sleep Research Centre at Université Laval in Quebec City. “The authorization of Somryst by the FDA provides patients suffering from chronic insomnia with a digitally-delivered CBTi therapeutic, where CBTi is the guideline recommended long-term, first-line treatment for chronic insomnia.”

The FDA submission was supported by two randomized controlled trials evaluating the effectiveness of the therapeutic [4]. Together, these studies enrolled more than 1,400 adults with chronic insomnia. In a trial of 303 patients with chronic insomnia, those on treatment demonstrated clinically meaningful improvements in insomnia severity, sleep onset latency (time to fall asleep) and wake after sleep onset (time awake at night) at the end of treatment, as well as at 6 and 12 months follow-up compared to active control. Results of the study were published in JAMA Psychiatry [5]. In a second study of 1,149 adult patients with chronic insomnia and depressive symptoms, those on treatment for 9 weeks saw a significant reduction in insomnia severity measurements compared to controls. These benefits persisted for over a 12-month period. The majority of patients randomized to the treatment arm for the PDT candidate no longer met clinical criteria for insomnia at the end of the 9-week treatment. Results of the study were published in Lancet Psychiatry [6].

“The FDA’s authorization of our third PDT, Somryst, demonstrates our ongoing commitment to redefine disease treatment through the development of PDTs,” said Corey McCann, M.D., Ph.D., President and CEO of Pear Therapeutics. “Now, more than ever, easily-accessible treatment options are imperative for patients suffering from chronic conditions. Pear has built the capabilities, pipeline, and platform to allow us to build PDTs that help patients across a variety of disease areas.”

Somryst is the third PDT to receive authorization from the FDA, following Pear’s reSET®, and reSET-O®. Somryst was submitted, reviewed and cleared through the traditional 510(k) pathway and was the first product reviewed through FDA’s Software Precertification Pilot Program, as part of the 2019 Test Plan released by the FDA in January 2019. Pear Therapeutics is one of nine companies taking part in the FDA’s Digital Health Software Precertification Pilot Program. As part of the program, Pear has been working closely with the FDA and volunteered to undergo the first-ever Excellence Appraisal in May 2019, consisting of an onsite evaluation of the company’s commitment and execution across product quality, patient safety, cybersecurity responsibility, clinical responsibility, and a proactive culture[3].

About Somryst

Somryst is a 9-week Prescription Digital Therapeutic (PDT) for chronic insomnia. Somryst can be used on a mobile device, such as a smartphone or tablet. Somryst 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 a Health Care Provider.

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.

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.

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, and 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.

About Pear Therapeutics

Pear Therapeutics is the leader in prescription digital therapeutics. We aim 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 severe psychiatric and neurological conditions. Our lead product, reSET®, for the treatment of Substance Use Disorder, was the first prescription digital therapeutic to receive marketing authorization from the FDA to treat disease. Pear’s second product, reSET-O®, for the treatment of Opioid Use Disorder, received marketing authorization from the FDA in December 2018. For more information, visit us at www.peartherapeutics.com.

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[1] https://www.fda.gov/medical-devices/digital-health/digital-health-software-precertification-pre-cert-program

[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.

[4] Somryst Regulatory Submission (K191716), 510(k) Regulatory file

[5] Ritterband LM, Thorndike, FP, Ingersoll, KS, et al. Effect of a Web-Based Cognitive Behavior Therapy for Insomnia Intervention With 1-Year Follow-up: A Randomized Clinical Trial. JAMA Psychiatry. 2017;74(1),68-75.

[6] Christensen H, Batterham PJ, Gosling JA, et al. Effectiveness of an online insomnia program (SHUTi) for prevention of depressive episodes (the GoodNight Study): a randomised controlled trial. Lancet Psychiatry. 2016;3(4):333-341.

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