- Camille Griffin Graham Correctional Institution, a state prison
for women in Columbia, S.C., is the first in the nation to
implement FDA-authorized PDTs in a correctional setting
- Collaboration delivers Pear’s reSET® and reSET-O®, for
treatment of substance use disorder and opioid use disorder, for
patients affected by addiction
The S.C. Department of Corrections (SCDC) today announced a plan
with Pear Therapeutics, Inc. (Nasdaq: PEAR), the leader in
developing and commercializing software-based medicines called
prescription digital therapeutics (PDTs), to offer FDA-authorized
PDTs to support women inmates in recovery from opioid and other
substance use disorders. This first of its kind collaboration in a
correctional setting supports SCDC’s commitment to leverage
innovative treatment options to provide care for individuals
seeking recovery. Eligible patients at the Camille Griffin Graham
Correctional Institution will be prescribed and treated with reSET
or reSET-O to help the facility expand access to addiction
services. This project is funded by the S.C. Department of Alcohol
and Other Drug Abuse Services.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20220901005096/en/
"We are excited to begin this cutting-edge treatment for our
female inmates who suffer from addiction,” SCDC Director Bryan
Stirling said. “We hope this can help break the cycle of addiction
that afflicts so many of our incarcerated people.”
According to the National Institute on Drug Abuse (NIDA), 85% of
the prison population in the United States has an active substance
use disorder or were incarcerated for a crime involving drugs or
drug use1. Further, inmates with opioid use disorder are at a
higher risk for overdose following release from incarceration1. A
recent study showed in the first two weeks after being released
from prison former inmates were 40 times more likely to die of an
opioid overdose than someone in the general population2.
"This project will build on our existing collaborations to treat
inmates with substance use disorders, proving that rehabilitation
and recovery do go hand in hand,” DAODAS Director Sara Goldsby
said. “We are very proud of our strong partnership with SCDC, and
we are excited to support another innovative project for recovering
inmates.”
Pear’s innovative FDA-authorized digital treatments are the
first of their kind authorized by FDA to treat substance use and
opioid use disorders, respectively. The products place
evidence-based therapy and treatment accountability in the palm of
the patient’s hand.
“Pear and the South Carolina Department of Corrections intend to
integrate innovative clinically validated technologies into the
treatment paradigm to combat addiction and support those at-risk,”
Julia Strandberg, Chief Commercial Officer of Pear said. “Our
prescription digital therapeutics are designed to help patients on
the path to recovery while our clinician dashboard allows
counselors to monitor patient progress.”
Prescription digital therapeutics are a new 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
for use by prescribing clinicians and for population health
management by payors and health systems.
The two products being implemented by SCDC -- 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 journals3,4. Pear recently
released publications showing the potential for improved real-world
health outcomes and decreased treatment costs for patients using
reSET and reSET-O5-16. Clinicians receive access to clinical
dashboards to inform visits with patients. 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.
Find more information about the products visit here and
here.
This program is supported by the State Opioid Response 2.0 (SOR)
Grant of the U.S. Substance Abuse and Mental Health Services
Administration (SAMHSA), U.S. Department of Health and Human
Services (FAIN H79TI0833000-02, CFDA # 93.788, Award dates:
09/30/2021 - 9/29/2022), through a financial assistance award
totaling $159,840.00 with 100 percent funded by SAMHSA. The
contents of this piece are those of the author(s) and do not
necessarily represent the official views of SAMHSA”
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 for Clinicians:
Warnings: reSET is intended for patients whose primary
language is English 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 is 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 prescription digital therapeutic.
Important Safety Information: Warnings: reSET-O is
intended for patients whose primary language is English 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 South Carolina Department of Corrections The S.C.
Department of Corrections operates 21 state prisons that house and
care for more than 15,000 incarcerated people. The department has
the lowest recidivism rate in the country and is considered a
leader in prison reform in the USA.
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.
References:
-
https://www.drugabuse.gov/publications/drugfacts/criminal-justice
-
https://www.sovhealth.com/addiction/study-finds-link-between-opioid-addiction-and-criminal-justice-system/
- 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
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220901005096/en/
Pear Therapeutics Meara Murphy
Senior Director of Corporate Communications
meara.murphy@peartherapeutics.com S.C.
Department of Corrections Chrysti Shain Director of
Communications shain.chrysti@doc.sc.gov
Pear Therapeutics (NASDAQ:PEAR)
Historical Stock Chart
From Jun 2024 to Jul 2024
Pear Therapeutics (NASDAQ:PEAR)
Historical Stock Chart
From Jul 2023 to Jul 2024