- The Wisconsin Department of Health Services awards Pear funding
towards access to Pear’s reSET® and reSET-O® to patients with
substance use disorder and opioid use disorder
- The program will support Wisconsinites on their recovery
journeys with innovative FDA-authorized treatments via their mobile
devices, aligned with DHS’ focus on supporting individual and
community health and well-being
Pear Therapeutics, Inc. (Nasdaq: PEAR), the leader in developing
and commercializing software-based medicines called prescription
digital therapeutics (PDTs), announced today that the Wisconsin
Department of Health Services (DHS) has entered into a contract for
services with Pear to provide Wisconsin residents with access to
Pear’s FDA-authorized PDTs reSET® and reSET-O® for the treatment of
substance use disorder (SUD) and opioid use disorder (OUD),
respectively. Eligible patients will be prescribed and treated with
reSET or reSET-O to help communities throughout Wisconsin expand
access to addiction care.
“The state of Wisconsin is making a difference for those
struggling with addiction by expanding access to evidence-based
treatment and recovery services,” said Julia Strandberg, Chief
Commercial Officer of Pear Therapeutics. “We have a shared goal to
ensure that people living with substance and opioid use disorders
have every opportunity for favorable outcomes for recovery. Pear
appreciates the Wisconsin DHS for their diligence in providing
Pear’s FDA-authorized PDTs to give residents seeking recovery 24/7
access to treatment when and where they need it most.”
According to the DHS, over the last year, synthetic opioids,
primarily fentanyl, were identified in 91 percent of opioid
overdose deaths and 73 percent of all drug overdose deaths in
Wisconsin.1 Provisional data shows the number of fentanyl overdose
deaths in Wisconsin grew by 97 percent from 2019 to 2021.1
DHS, which seeks to increase community-level supports for people
who have substance use challenges, intends to make reSET and
reSET-O available through participating providers in a variety of
outpatient treatment settings, including opioid treatment programs
that also administer transmucosal buprenorphine to prescribe and
treat patients in Wisconsin.
reSET and reSET-O have been tested in real-world use and
randomized controlled trials, with results published in
peer-reviewed medical journals.2-16 Both products, which are
adjunctive to outpatient counselling, provide patients with
algorithm-driven cognitive behavioral therapy, fluency training,
and contingency management, while clinicians receive access to
clinical dashboards to inform in-office and tele visits. 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
transmucosal buprenorphine for patients 18 years of age or older
with opioid use disorder.
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 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.dhs.wisconsin.gov/opioids/ph-advisory.htm
- 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/20221103005476/en/
Media & Investors: Meara Murphy Senior Director of Corporate
Communications meara.murphy@peartherapeutics.com
Pear Therapeutics (NASDAQ:PEAR)
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