- BrightView expands its initiative with reSET® and reSET-O® to
patients across Kentucky, Ohio, Delaware, Massachusetts, and
Virginia
Pear Therapeutics, Inc. (Nasdaq: PEAR), the leader in developing
and commercializing software-based medicines called prescription
digital therapeutics (PDTs), announced today the expansion of its
collaboration with BrightView Health, an addiction treatment
provider that offers evidence-based, outpatient addiction treatment
programs. This initiative is designed to provide eligible adults
suffering from substance use disorder (SUD) and opioid use disorder
(OUD) access to reSET® and reSET-O®. BrightView, an innovative and
patient-focused leader in SUD and OUD treatment, began piloting
Pear’s products in its centers across six locations in Kentucky and
Ohio in early 2022, and intends to expand the initiative across
Kentucky, Ohio, Delaware, Massachusetts, and Virginia. BrightView
currently has over 80 locations across 8 states.
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“We strive to make recovery work for patients and to meet them
where they are,” said Shawn Ryan, MD, MBA, ABEM, ABAM, Chief
Science Officer, of BrightView Health. “We believe reSET and
reSET-O are beneficial to our patients, the community, and our
health system. BrightView plans to continue expanding our use of
Pear’s PDTs to help patients achieve progress in recovery.”
Substance use disorders are a major public health crisis
affecting communities across the country. In 2020 alone, drug
overdose deaths in Kentucky increased by nearly 50%, with a state
report concluding that isolation caused by the pandemic was a major
contributing factor.1 According to RecoveryOhio’s annual review
from 2021, 10-15% of all Ohioans have a life history of substance
use disorder.2 Pear and BrightView are working together to help
improve access to care for those affected by this national
epidemic.
“As the severity of the addiction crisis continues to increase,
Pear is proud to be working with BrightView to provide innovative
treatments to Kentuckians and Ohioans,” said Julia Strandberg,
Chief Commercial Officer of Pear. “We look forward to expanding
these efforts and engaging new patients.”
The two products being piloted by BrightView -- reSET and
reSET-O -- have been measured in real-world use and their
therapeutic content studied in randomized controlled trials, with
results published in peer-reviewed medical journals.3,4
Additionally, Pear has released publications showing the potential
for improved real-world health outcomes and decreased treatment
costs for patients using reSET and reSET-O.5-17 reSET is used as a
monotherapy for patients 18 years of age or older with substance
use disorder and reSET-O is used in combination with
buprenorphine-based medication assisted treatment for patients 18
years of age or older with opioid use disorder. Clinicians receive
access to clinical dashboards to inform visits with patients. More
information may be found about the products here and here.
reSET Important Safety Information Indications for
Use: reSET is intended to provide cognitive behavioral therapy,
as an adjunct to a contingency management system, for patients 18
years of age and older, who are currently enrolled in outpatient
treatment under the supervision of a clinician. reSET is indicated
as a 12-week (90 day) prescription-only treatment for patients with
substance use disorder (SUD), who are not currently on opioid
replacement therapy, who do not abuse alcohol solely, or who do not
abuse opioids as their primary substance of abuse.
It is intended to:
- Increase abstinence from a patient’s substances of abuse during
treatment, and
- Increase retention in the outpatient treatment program.
Important Safety Information: Warnings: reSET is
intended for patients whose primary language is English or Spanish
with a reading level of 7th grade or above, and who have access to
an Android/iOS tablet or smartphone. reSET is intended only for
patients who own a smartphone and are familiar with use of
smartphone apps (applications).
Clinicians should not use reSET to communicate with their
patients about emergency medical issues. Patients should be clearly
instructed not to use reSET to communicate to their clinician any
urgent or emergent information. In case of an emergency, patients
should dial 911 or go to the nearest emergency room.
reSET is not intended to be used as a stand-alone therapy for
substance use disorder (SUD). reSET does not replace care by a
licensed medical practitioner and is not intended to reduce the
amount of face-to-face clinician time. reSET does not represent a
substitution for a patient’s medication. Patients should continue
to take their medications as directed by their healthcare
provider.
Patients with substance use disorder experience mental health
disease and co-morbid medical problems at higher rates than the
general population. Patients with substance use disorder also have
higher baseline rates of suicidal ideation, and suicide attempts,
and suicide completion. Clinicians should engage in their normal
care practices to monitor patients for medical problems and mental
health disorders, including risk for harming others and/or
themselves.
The long-term benefit of treatment with reSET on abstinence has
not been evaluated in studies lasting beyond 12 weeks (90 days) in
the SUD population. The ability of reSET to prevent potential
relapse after treatment discontinuation has not been studied.
The effectiveness of reSET has not been demonstrated in patients
currently reporting opioids as their primary substance of
abuse.
This Press Release does not include all the information needed
to use reSET safely and effectively. Please see the Clinician Brief
Summary for reSET for more information.
reSET-O Important Safety Information
Indications for Use: reSET-O prescription digital
therapeutic is a 12-week (84 day) software application intended to
increase retention of patients with opioid use disorder (OUD) in
outpatient treatment by providing cognitive behavioral therapy, as
an adjunct to outpatient treatment that includes transmucosal
buprenorphine and contingency management, for patients 18 years or
older who are currently under the supervision of a clinician.
reSET-O is indicated as a prescription-only digital
therapeutic.
Important Safety Information:
Warnings/precautions: reSET-O is intended for patients whose
primary language is English or Spanish with a reading level of 7th
grade or above, and who have access to an Android/iOS tablet or
smartphone. reSET-O is intended only for patients who own a
smartphone and are familiar with use of smartphone apps
(applications).
Clinicians should not use reSET-O to communicate with their
patients about emergency medical issues. Patients should be clearly
instructed not to use reSET-O to communicate to their clinician any
urgent or emergent information. In case of an emergency, patients
should dial 911 or go to the nearest emergency room.
reSET-O is not intended to be used as a stand-alone therapy for
Opioid Use Disorder (OUD). reSET-O does not replace care by a
licensed medical practitioner and is not intended to reduce the
frequency or duration of in-person therapy. reSET-O does not
represent a substitution for a patient’s medication. Patients
should continue to take their medications as directed by their
healthcare provider.
Patients with opioid use disorder experience mental health
disease and co-morbid medical problems at higher rates than the
general population. Patients with opioid use disorder have higher
baseline rates of suicidal ideation, and suicide attempts, and
suicide completion. Clinicians should undertake standard of care to
monitor patients for medical problems and mental health disease,
including risk for harming others and/or themselves.
The long-term benefit of reSET-O has not been evaluated in
studies lasting beyond 12 weeks (84 days) in the OUD population.
The ability of reSET-O to prevent potential relapse after therapy
discontinuation has not been studied.
This Press Release does not include all the information needed
to use reSET-O safely and effectively. Please see the Clinician
Brief Summary Instructions for reSET-O for more information.
About BrightView Health Founded in 2015, BrightView
provides comprehensive, evidence-based outpatient addiction
treatment to thousands of patients in recovery from substance use
disorder throughout Massachusetts, Kentucky, Ohio, Virginia,
Delaware, Maryland, Arizona, and North Carolina.
The organization’s more than 80 centers provide a practical
treatment approach that includes medication assisted treatment
(MAT), individual counseling, group therapy, peer support, and
wraparound social services, as well as work on co-occurring
disorders. Locations are generally able to dispense medication
on-site, which makes treatment comfortable and convenient for
patients.
BrightView's compassionate and professional staff create an
accessible and welcoming environment for physical and emotional
healing. BrightView is committed to treating each patient with
respect, providing positive reinforcement, and achieving long-term
wellness. To learn more, please visit brightviewhealth.com.
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 Disclaimer 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, whether
Brightview expands the initiative with Pear across Kentucky, Ohio,
Delaware, Massachusetts, and Virginia, whether reSET and reSET-O
provide benefits to patients, the community, and the health system,
whether reSET and reSET-O are beneficial for patient care and
outcomes, whether Brightview plans to continue expanding its use of
Pear’s PDTs, and whether Pear’s PDTs help patients achieve success
in recovery. In some cases, you can identify forward-looking
statements by terminology such as “may”, “can”, “should”, “could”,
“might”, “plan”, “possible”, “strive”, “aim”, “expect”, “intend”,
“will”, “estimate”, “believe”, “predict”, “potential”, or
“continue”, or the negatives of these terms 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), the rate at which customers integrate
Pear’s PDTs into their treatment paradigms, (ii) changes in
applicable laws or regulations; (iii) the possibility that Pear may
be adversely affected by other economic, business, regulatory,
and/or competitive factors; (iv) the evolution of the markets in
which Pear competes; (v) the ability of Pear to defend its
intellectual property and satisfy regulatory requirements; (vi) the
impact of the COVID-19 pandemic on Pear’s business; and (vii) 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, which are based only on information
currently available to us and speak only as of the date of this
release. Pear assumes no obligation to publicly update or revise
these forward-looking statements, whether as a result of new
information, future events, or otherwise, except as may be required
by law. Pear gives no assurance that Pear will achieve its
expectations.
References:
-
https://apnews.com/article/lifestyle-health-pandemics-coronavirus-pandemic-kentucky-9555b1ccdc9df17c9a1e206090fb14b2
- RecoveryOhio 2021 Annual Review
- Campbell ANC, Nunes EV, Matthews AG, et al. Internet-delivered
treatment for substance abuse: a multisite randomized controlled
trial. Am J Psychiatry. 2014;171(6):683-690.
- Christensen DR, Landes RD, Jackson L, et al. Adding an
Internet-delivered treatment to an efficacious treatment package
for opioid dependence. J Consult Clin Psychol. 2014;82(6):964-972.
doi:10.1037/a0037496.
- Yuri A. Maricich, MD, Xiaorui Xiong, PhD, Robert Gerwien, PhD,
Alice Kuo, BA Fulton Velez, MD MBA, Bruce Imbert, MD PhD, Keely
Boyer, MBA, Hilary F. Luderer, PhD, Stephen Braun, BA, Karren
Williams, PhD (2020): Real-World evidence for a prescription
digital therapeutic to treat Opioid Use Disorder, Journal of
Current Medical Research and Opinion,
DOI:10.1080/03007995.2020.1846023.
- Fulton F. Velez, Sam Colman , Laura Kauffman , Charles Ruetsch
& Kathryn Anastassopoulos (2020): Real-world reduction in
healthcare resource utilization following treatment of opioid use
disorder with reSET-O, a novel prescription digital therapeutic,
Expert Review of Pharmacoeconomics & Outcomes Research, DOI:
10.1080/14737167.2021.1840357
- Weijia Wang, Nicole Gellings Lowe, Ali Jalali & Sean M.
Murphy (2021) Economic modeling of reSET-O, a prescription digital
therapeutic for patients with opioid use disorder, Journal of
Medical Economics, 24:1, 61-68, DOI:
10.1080/13696998.2020.1858581
- Yuri A. Maricich, Warren K. Bickel, Lisa A. Marsch, Kirstin
Gatchalian, Jeffrey Botbyl & Hilary F. Luderer (2020) Safety
and efficacy of a prescription digital therapeutic as an adjunct to
buprenorphine for treatment of opioid use disorder, Current Medical
Research and Opinion, DOI: 10.1080/03007995.2020.1846022
- Fulton F. Velez, Hilary F. Luderer, Robert Gerwien, Benjamin
Parcher, Dylan Mezzio & Daniel C. Malone (2021) Evaluation of
the cost-utility of a prescription digital therapeutic for the
treatment of opioid use disorder, Postgraduate Medicine, DOI:
10.1080/00325481.2021.1884471
- Fulton F. Velez, Charles Ruetsch & Yuri Maricich (2021)
Evidence of long-term real-world reduction in healthcare resource
utilization following treatment of opioid use disorder with
reSET-O, a novel prescription digital therapeutic, Expert Review of
Pharmacoeconomics & Outcomes Research, DOI:
10.1080/14737167.2021.193968
- Fulton F. Velez & Daniel C. Malone (2021)
Cost-Effectiveness Analysis of a Prescription Digital Therapeutic
for the Treatment of Opioid Use Disorder, Journal of Market Access
& Health Policy, 9:1, DOI: 10.1080/20016689.2021.1966187
- Yuri A. Maricich, Robert Gerwien, Alice Kuo, Daniel C. Malone
& Fulton F. Velez (2021) Real-world use and clinical outcomes
after 24 weeks of treatment with a prescription digital therapeutic
for opioid use disorder, Hospital Practice, DOI:
10.1080/21548331.2021.1974243
- Velez FF, Colman S, Kauffman L, Ruetsch C, Anastassopoulos K,
Maricich YA. Comparison of Healthcare Resource Utilization Between
Patients Who Engaged or Did Not Engage With a Prescription Digital
Therapeutic for Opioid Use Disorder. Clinicoecon Outcomes Res.
2021;13:909-916 https://doi.org/10.2147/CEOR.S334274.
- Velez, F.F., Anastassopoulos, K.P., Colman, S. et al. Reduced
Healthcare Resource Utilization in Patients with Opioid Use
Disorder in the 12 Months After Initiation of a Prescription
Digital Therapeutic. Adv Ther (2022).
https://doi.org/10.1007/s12325-022-02217-y
- Shah, N., Velez, F.F., Colman, S. et al. Real-World Reductions
in Healthcare Resource Utilization over 6 Months in Patients with
Substance Use Disorders Treated with a Prescription Digital
Therapeutic. Adv Ther (2022).
https://doi.org/10.1007/s12325-022-02215-0
- Luderer H, Campbell A, Nunes E, Enman N, Xiong X, Gerwein R,
Maricich Y. Engagement patterns with a digital therapeutic for
substance use disorders: Correlations with abstinence outcomes.
Journal of Substance Use Disorders. 132 (2021) 108585.
https://doi.org/10.1016/j.jsat.2021.108585
- Xiong, X, Braun, S, Stitzer, M, et al. Evaluation of real-world
outcomes associated with use of a prescription digital therapeutic
to treat substance use disorders. Am J Addict. 2022; 1- 8.
doi:10.1111/ajad.13346.
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version on businesswire.com: https://www.businesswire.com/news/home/20230126005206/en/
Pear Therapeutics Meara Murphy Senior Director, Corporate
Communications meara.murphy@peartherapeutics.com
BrightView Health David McDonald Public Relations Manager
press@brightviewhealth.com
Pear Therapeutics (NASDAQ:PEAR)
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