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®
August 10 2022 - 4:02PM
Business Wire
- Somryst® is the only FDA-authorized prescription digital
therapeutic (PDT) for the treatment of chronic insomnia
- 24-month analysis showing $2,059 reduction in per-patient costs
adds to the body of evidence to support the use of this PDT among
people with chronic insomnia1
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:
- 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
- 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.
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Media and Investors: Meara Murphy Senior Director,
Corporate Communications meara.murphy@peartherapeutics.com Golin
golinpear@golin.com
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