- Spero Health, one of the nation’s largest office-based
outpatient opioid treatment providers for individuals in recovery,
to expand patient access to Pear’s prescription digital
therapeutics (PDTs) for the treatment of substance use disorder
(SUD) and opioid use disorder (OUD)
- Expansion has the potential to deliver Pear’s FDA-authorized
reSET® and reSET-O® PDTs to eligible patients across Spero’s 99
locations throughout Indiana, Kentucky, Ohio, Tennessee, West
Virginia, and Virginia
Pear Therapeutics, Inc. (Nasdaq: PEAR), the leader in developing
and commercializing software-based medicines called prescription
digital therapeutics (PDTs), today announced the expansion of its
collaboration with Spero Health, an integrated healthcare services
organization specializing in local and affordable outpatient care
for individuals suffering from substance use disorders, to provide
adults suffering from substance use disorder (SUD) and opioid use
disorder (OUD) access to reSET® and reSET-O®, for each respective
condition. Spero Health, which has implemented reSET and reSET-O at
14 locations in Kentucky, intends to expand access to eligible
patients at its 99 locations throughout Indiana, Kentucky, Ohio,
Tennessee, West Virginia, and Virginia. The expansion is part of
Spero Health’s commitment to increase patient engagement and
retention in recovery by offering FDA-authorized innovative
treatment options.
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the full release here:
https://www.businesswire.com/news/home/20230104005238/en/
“Spero Health continues to find innovative ways with new
technologies to bring solutions to our communities that have been
devastated by drug overdose, and we are looking forward to our
collaboration with Pear Therapeutics to pursue even better outcomes
in treatment,” said Steve Priest, Spero Health’s CEO. “Pear’s
technology equips our clinicians with vital measurements via a
clinician dashboard that allows us to provide quality care to our
patients who suffer from substance use disorders. We believe having
access to patient reported data via Pear’s clinician dashboard
gives us better insight into patient behaviors. We expect that this
approach will help to increase compliance and create efficiencies
in how our treatment teams deliver care.”
As one of the nation’s largest office-based outpatient opioid
treatment providers, Spero Health has helped more than 35,000
patients on their journey to stable recovery. Spero Health strives
to meet people where they are by offering a community-based
approach to treatment utilizing an evidence-based integrated care
model that combines both physical and behavioral healthcare
services under one roof.
“With more than 40 million Americans living with addiction, we
are proud to expand our work with Spero Health to help more
patients who are seeking recovery solutions,” said Julia
Strandberg, Chief Commercial Officer at Pear Therapeutics. “Through
our shared commitment to break down barriers and meet patients
where they are, we can deliver our innovative PDTs for the
treatment of substance use disorder and opioid use disorder to help
patients stay on their recovery journey.”
Prescription digital therapeutics are an innovative class of
treatments that use software to treat serious disease. Like
traditional medicines, these products are evaluated and authorized
by regulators like the Food and Drug Administration (FDA) and used
under the supervision of a prescribing clinician. Unlike
traditional medicines, they are designed to collect real world data
that may be used by clinicians to inform treatment and by payors
and health systems for population health management.
The two products being implemented by Spero Health, reSET and
reSET-O, have previously 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 Most
recently, Pear 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. Find
more information 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 Spero Health Spero Health, Inc., is an integrated
healthcare services organization specializing in local and
affordable outpatient care for individuals suffering from substance
use disorders with a mission to “Save Lives, Instill Hope, and
Restore Relationships.” Spero Health utilizes an innovative
evidence-based integrated care model that combines both physical
and behavioral healthcare services under one roof to treat the
whole patient. This integrated care model combines physician
services (including medication-assisted treatment), behavioral
health counseling, recovery support services, medication management
and patient and family education. Its community-based approach to
treatment allows patients to continue working and caring for their
families as they overcome addiction. Based in Nashville, Tenn. and
privately held by Heritage Group, Health Velocity Capital, South
Central, Inc. and Frist Cressey Ventures, Spero Health operates 99
outpatient clinics located throughout Kentucky, Ohio, Indiana,
Virginia, West Virginia and Tennessee. Spero Health is a national
leader who has helped more than 35,000 patients on their journey to
stable recovery from addiction and is in-network with Medicaid and
most commercial insurance plans.
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, whether
Pear and Aspro Health expand access to PDTs for people in recovery
across multiple locations and states, whether customer access to
patient reported data via the Clinician Dashboard gives them better
insight into patient behaviors, whether using Pear’s PDTs increase
compliance and create efficiencies in how customers deliver care,
whether our products increase access, improve outcomes, and deliver
value for patients, providers, and payors, and whether our products
collect real world data that can be for used by prescribing
clinicians to inform treatment and for population health management
by payors and health systems for population health management, are
forward-looking statements. 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
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- 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
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& Kathryn Anastassopoulos (2020): Real-world reduction in
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Expert Review of Pharmacoeconomics & Outcomes Research, DOI:
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- Weijia Wang, Nicole Gellings Lowe, Ali Jalali & Sean M.
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- Yuri A. Maricich, Warren K. Bickel, Lisa A. Marsch, Kirstin
Gatchalian, Jeffrey Botbyl & Hilary F. Luderer (2020) Safety
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- Fulton F. Velez, Hilary F. Luderer, Robert Gerwien, Benjamin
Parcher, Dylan Mezzio & Daniel C. Malone (2021) Evaluation of
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Pear Therapeutics Meara Murphy Senior Director, Corporate
Communications meara.murphy@peartherapeutics.com Spero Health
Ginger Jackson VP, Marketing and Communications
ginger.jackson@sperohealth.com
Pear Therapeutics (NASDAQ:PEAR)
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