Mar 27,2020

Q&A: A firsthand account of FDA's Pre-Cert Program

Yesterday, Pear Therapeutics announced the regulatory clearance of Somryst, its prescription digital therapeutic for chronic insomnia. MobiHealthNews spoke with Pear's chief medical officer, Dr. Yuri Maricich, about his company's experience clearing a digital health software product through the experimental program: What kinds of qualifications the FDA sought, the unexpected surprises Pear faced, and which digital health companies might be interested in pursuing precertification once the program has been finalized.

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#software

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May 12,2020

Digital Therapeutic Sleepio™ Yields 28% Lower Healthcare Costs

Big Health, the global leader in digital therapeutics dedicated to helping millions back to good mental health, today announced key findings from a health economic evaluation of Sleepio™, a digital sleep improvement program. The study was conducted at a self-insured Fortune 500 company, in collaboration with IBM Watson Health, and Dr. Laurence Baker, a health economic consultant. Dr. Baker also holds an appointment as a Professor of Health Research and Policy at Stanford University. The study compared two groups of employees—a group of Sleepio users and a matched control group—and compared their respective healthcare costs over an 18-month follow-up period. The results demonstrated 28% lower total healthcare costs in the cohort of Sleepio users, as compared to the matched control group.

CLINICAL STUDY
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Jul 13,2020

PEAR THERAPEUTICS ANNOUNCES FIRST PARTICIPANT ENROLLED IN VIRTUAL REAL-WORLD STUDY OF ADULTS WITH CHRONIC INSOMNIA

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.

PRODUCT

#pdt

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Jul 31,2020

Digital therapy for insomnia could save NHS millions and improve anxiety and depression symptoms

New report finds use of Sleepio delivers high recovery rates, improve mental health outcomes & could save the NHS £56 million over three years. Patients living with the condition who used Sleepio – a digital sleep improvement programme featuring CBT techniques – had a recovery rate of 56 percent. The report also highlights the findings of an independent study conducted by the Office of Health Economics across nine GP practices in the Thames Valley, which found that Sleepio resulted in a projected saving of £106 per patient over three years. If Sleepio were made available across all clinical commissioning groups (CCGs) in England, this could represent savings for the NHS of as much as £56 million over three years.

CLINICAL STUDY

#cbt

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Aug 20,2020

Sleepio study suggests insomnia treatment could also improve depressive symptoms

The use of cognitive-behavioral therapy interventions, such as Big Health’s Sleepio program, has been found to improve both sleep and mental health in individuals with insomnia and clinically significant depressive symptoms, according to new research published in the Journal of Sleep Research. Although the study was conducted at the University of Oxford, some of the researchers have financial ties to Big Health, and parts of the investigation were funded by Big Health. The study included 3,352 participants as a sub-analysis of data collected from two randomized control trials measuring the effectiveness of Sleepio. Researchers found that addressing sleep problems in individuals who also have depressive symptoms could increase the resolution of depressive symptoms by up to three times.

CLINICAL STUDY

#cbt

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Aug 31,2020

Pear Therapeutics Announces Data from Two Studies Evaluating Somryst™ for Chronic Insomnia Presented at Virtual SLEEP 2020

Pear Therapeutics, Inc. announced findings today from two studies of an experimental precursor of Somryst™ (called SHUTi) that evaluated effectiveness to improve sleep outcomes and analyzed user journey data to predict intervention dropout, respectively. The current study evaluated 1,149 Australian adults aged 18-64 years with insomnia and depressive symptoms for the effectiveness of SHUTi vs. an attention-matched control with improving sleep outcomes measured by prospectively entered sleep diary data. Findings from a large-scale randomized controlled trial, Web-delivered CBT for Insomnia Intervention Improves Sleep Among Adults with Insomnia and Depressive Symptoms, show that Somryst can produce lasting improvements in sleep outcomes among adults with insomnia and elevated depressive symptoms.

CLINICAL STUDY

#pdt

#cbt

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Oct 23,2020

Big Health Offers Election Volunteers No Cost Access to Digital Therapeutics for Poor Sleep and Worry and Anxiety

Big Health, a digital therapeutics company dedicated to helping millions back to good mental health, today announced that it is offering election volunteers and officials in the U.S. no cost access to its products — Sleepio™ for helping individuals address poor sleep, and Daylight™ for helping individuals address worry and anxiety — through the end of the year.

#mobile app

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Nov 17,2020

PEAR THERAPEUTICS LAUNCHES SOMRYST™ FOR CHRONIC INSOMNIA VIA AN END-TO-END VIRTUAL CARE EXPERIENCE

Pear Therapeutics, Inc., today announced the availability of 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 addresses the underlying issues of chronic insomnia by delivering cognitive behavioral therapy for insomnia (CBTi), an evidence-based approach that trains the brain and body to sleep. Somryst will be promoted via a fully virtual experience, combining telemedicine visit(s) and PDT prescribing and dispensation via PearConnect™.

PRODUCT

#virtual care

#telehealth

#cbt

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Dec 16,2020

Simulation model: Big Health's Sleepio drives greater cost savings than group CBT or drug therapy

The research was funded by Big Health, and conducted by researchers from Johns Hopkins, the University of California, San Francisco, and the digital health company. The mathematical simulation model found that, compared to other insomnia interventions like group cognitive behavioral therapy or pharmacotherapy, digital CBT delivered via Big Health's Sleepio was more cost-effective due to lower expenditures. Compared to no insomnia treatment, the model indicated a net monetary benefit of $681.06 per individual receiving Sleepio over six months.

CLINICAL STUDY

#mobile app

#cbt

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Jul 22,2019

Pear Therapeutics' digital insomnia therapeutic will put FDA's PreCert framework through its paces

Prescription digital therapeutics company Pear Therapeutics announced late last week that it has filed an FDA marketing authorization for Somryst, its digital cognitive behavioral therapy for the treatment of adults with chronic insomnia and depression. While an approval from the agency would mark the third authorized prescription digital therapeutic for Pear — behind reSET for substance use disorder and reSET-O for opioid use disorder — the Somryst application is also the first product to CEO and President Dr. Corey McCann’s knowledge submitted through the FDA’s Precertification Program’s Working Model.

PRODUCT

#mobile app

#cbt

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