• 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.

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"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 journals^3,4. Pear recently released publications showing the potential for improved real-world health outcomes and decreased treatment costs for patients using reSET and reSET-O^5-16. 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:

1. https://www.drugabuse.gov/publications/drugfacts/criminal-justice
2. https://www.sovhealth.com/addiction/study-finds-link-between-opioid-addiction-and-criminal-justice-system/
3. 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.
4. 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.
5. 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.
6. 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
7. 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
8. 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
9. 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
10. 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
11. 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
12. 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
13. 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.
14. 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
15. 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
16. 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

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