BOSTON & SAN FRANCISCO--(BUSINESS WIRE)--Pear Therapeutics, Inc. today announced the first participant enrolled in an open-label, decentralized clinical trial (called the DREAM study) evaluating Somryst™, an FDA-authorized prescription digital therapeutic (PDT) for the treatment of chronic insomnia. The DREAM study will enroll approximately 350 adults in the United States with chronic insomnia for nine weeks of digitally-delivered treatment and collect data in a real-world insomnia population.
Pear has developed its own decentralized and fully virtual clinical trial infrastructure for participant recruitment, screening, consent, enrollment, follow up, and progress tracking, which will be used for the DREAM study. This decentralized, fully site-less approach allows clinical studies such as DREAM to advance rapidly even as COVID-19 constrains the ability to safely conduct clinical studies and real-world research involving in-clinic visits. Eligible participants across the United States can enroll without ever needing to attend a physical clinical site.
The aim of the DREAM study is to further examine the real-world impact of Somryst on chronic insomnia, depression, and anxiety symptoms in patients with chronic Insomnia. DREAM will also collect self-reported healthcare utilization data, including quality of life and work attendance and productivity, during the study and up to one year follow up. The DREAM study will recruit participants between 22 and 75 years old, inclusively, who meet the criteria of chronic insomnia as defined by an Insomnia Severity Index (ISI) score of 8 or above and insomnia symptoms for at least 3 months, and have access to a mobile device. For more information about enrollment in the DREAM study, please visit www.somryst.com.
“Insomnia, anxiety, and depression are on the rise due to the COVID-19 pandemic,” said Yuri Maricich, M.D., Chief Medical Officer at Pear Therapeutics. “Cognitive Behavioral Therapy for insomnia (CBTi) is considered first-line treatment for chronic insomnia, but the majority of people do not have access to nor receive the recommended treatment. By delivering CBTi digitally, we can learn from people with chronic insomnia, address their critical needs and remove the barriers for accessing guideline recommended treatment.”
While pharmacotherapy is readily accessible and effective for some in the short term, it can lead to problems with tolerance and can have unwanted side-effects and habit-forming risks.1 FDA recently issued Boxed Warnings for risk of serious injuries caused by certain prescription insomnia medications.2,3 CBTi has longer-lasting benefits, is an evidence-based approach and is first-line of treatment recommended for adults with chronic insomnia by the American Academy of Sleep Medicine and the American College of Physicians clinical guidelines.1 Currently, Pear’s PDT Somryst™ is the only FDA authorized therapeutic that delivers guideline recommended first-line treatment for chronic insomnia.4,5
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.
Safety Information and Warnings
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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, and ensuring no one else may access their device.
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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.
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 is the leader in prescription digital therapeutics, or PDTs. Pear aims 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 the first three PDTs with disease treatment claims from FDA. Pear’s lead product, reSET®, for the treatment of Substance Use Disorder, was the first PDT to receive marketing authorization from 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.
1. Qaseem A, Kansagara D, Forciea MA, Cooke M, Denberg TD; Clinical Guidelines Committee of the American College of Physicians. Management of Chronic Insomnia Disorder in Adults: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2016;165(2):125-133. doi:10.7326/M15-2175.
2. https://aasm.org/fda-new-warning-insomnia-medications/
4 https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191716.pdf
5 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191716
