Christianacare Teams With Pear Therapeutics to Bring Patients Access to New Therapeutic Class of FDA-authorized Prescription Digital Therapeutics for Treatment of Substance Use Disorders
November 12, 2020
- ChristianaCare is expanding its innovative work to transform care through data and technology by adding Pear’s prescription digital therapeutics (PDTs), reSET® and reSET-O®, for treatment of substance use disorder and opioid use disorder, respectively.
Boston and Wilmington, Del., November 12, 2020 — Patients in Delaware and surrounding communities seeking treatment for opioid and substance use disorders will now have access to an innovative FDA-authorized treatment option, prescription digital therapeutics (PDTs), thanks to a collaboration between ChristianaCare and Pear Therapeutics, Inc.
ChristianaCare is advancing its leadership in harnessing value-based digital care by providing access to Pear’s reSET® and reSET-O® PDTs through Project Recovery, the organization’s outpatient program for people with substance-use disorders.
“The COVID-19 pandemic has highlighted the vital importance of connecting people with substance-use disorder to effective therapies, and ensuring that they have access to these therapies when and where they need it,” said Jolomi Ikomi, M.D., medical director of Project Recovery at ChristianaCare. “FDA-authorized prescription digital therapeutics used with complementary therapy are shown to keep patients on the path to recovery. The use of proven software-based therapeutics could provide innovative, convenient and cost-effective care to assist in the fight against addiction.”
Delaware has the second-highest rate of overdose deaths in the nation, according to the Centers for Disease Control and Prevention. Substance and opioid use disorders are chronic, treatable diseases. Staying in treatment is critical for people on their recovery journey. reSET and reSET-O will give patients a discreet, 24/7 evidence-based tool to complement their remote or in-office addiction therapy provided by their care team.
“Pear is excited to team with ChristianaCare to integrate our PDTs into their treatment paradigm for suitable patients who are fighting the battle of opioid or substance use disorder,” said Julia Strandberg, chief commercial officer of Pear Therapeutics. “We believe these innovative therapies can benefit ChristianaCare patients.”
reSET and reSET-O are the first two PDTs to receive market authorization to treat disease from FDA. Both products have been tested in real world use and randomized controlled trials, with results published in peer-reviewed medical journals. 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, which is intended to increase abstinence from a patient’s substances of abuse during treatment and to increase retention in the outpatient treatment program, is used as a monotherapy for patients with substance use disorder. reSET-O, which is intended to increase retention of patients in outpatient treatment, is used in combination with transmucosal buprenorphine for patients with opioid use disorder.
PDTs are a new therapeutic class that uses software to directly treat disease. Like traditional medicines, PDTs are developed in a GMP-compliant environment, tested in randomized controlled trials demonstrating safety and effectiveness, evaluated and authorized by regulators like FDA, and used under the supervision of a prescribing clinician1,2. Unlike traditional medicines, PDTs are designed to collect real world data for use by prescribing clinicians and for population health management by payors and health systems.
Headquartered in Wilmington, Delaware, ChristianaCare is one of the country’s most dynamic health care organizations, centered on improving health outcomes, making high-quality care more accessible and lowering health care costs. ChristianaCare includes an extensive network of primary care and outpatient services, home health care, urgent care centers, three hospitals (1,299 beds), a free-standing emergency department, a Level I trauma center and a Level III neonatal intensive care unit, a comprehensive stroke center and regional centers of excellence in heart and vascular care, cancer care and women’s health. It also includes the pioneering Gene Editing Institute and was rated by IDG Computerworld as one of the nation’s Best Places to Work in IT. ChristianaCare is a nonprofit teaching health system with more than 260 residents and fellows. With the unique CareVio data-powered care coordination service and a focus on population health and value-based care, ChristianaCare is shaping the future of health care. Learn how ChristianaCare delivers greater quality and value at https://christianacare.org.
About Pear Therapeutics
Pear Therapeutics is the leader in prescription digital therapeutics, or PDTs. Pear aims to redefine medicine by discovering, developing, and delivering 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 a pipeline of products and product candidates across therapeutic areas, including the first three PDTs with disease treatment claims from FDA. Pear’s lead product, reSET®, for the treatment of substance use disorder, was the first PDT to receive marketing authorization from 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.
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 and whose reading level is at the 7th grade level 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 represent a substitution for a patient’s medication. Patients should continue to take their medications as directed by their healthcare provider.
reSET should not be used by individuals outside active enrollment in a SUD treatment program. It should only be used as an adjunct to face-to-face counseling and contingency management. reSET is not intended to reduce the amount of face-to-face clinician time.
The long-term benefit of treatment with reSET on abstinence has not been evaluated in studies lasting beyond 12-weeks 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.
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 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).
reSET-O should not be used by individuals outside active OUD treatment. It is not intended to replace treatment by you, the patient’s medical provider. It should be used as an adjunct to clinician treatment, buprenorphine treatment and contingency management.
reSET-O is not intended to be used as a stand-alone therapy for Opioid Use Disorder (OUD). 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. The ability of reSET-O to prevent potential relapse after therapy discontinuation has not been studied.
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.
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- 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.