BOSTON & SAN FRANCISCO–(BUSINESS WIRE)–Feb 17, 2021–
Pear Therapeutics, Inc. announced today that the Indiana Family and Social Services Administration’s Division of Mental Health and Addiction (DMHA) is providing access to Pear’s FDA-authorized prescription digital therapeutics (PDTs) reSET® and reSET-O® for the treatment of substance use disorder (SUD) and opioid use disorder (OUD), respectively. Patients will be prescribed and treated with reSET or reSET-O. Funding is provided by the State Opioid Response grant, administered by DMHA, and part of the U.S. Department of Health and Human Services’ Substance Abuse and Mental Health Services Administration (SAMHSA) State Opioid Response (SOR) grant program for people in need of prevention, treatment and recovery support for opioid use disorder.
DMHA will make reSET and reSET-O available to participating providers in a variety of outpatient treatment settings and opioid treatment programs that also administer transmucosal buprenorphine to prescribe and treat patients across the state of Indiana. Pear will also conduct an evaluation of the de-identified data, including outcome measurements and an assessment of the impact of reSET and reSET-O on the state of Indiana’s health care resources and use within the patient population.
“The state of Indiana is leading the way in combating the epidemic of addiction and making it a priority amid the pandemic. Pear is proud to work with DMHA through the SOR grant program to give patients across the state 24/7 access to treatment through their mobile devices,” said Julia Strandberg, Chief Commercial Officer of Pear Therapeutics.
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. Pear recently released publications showing the potential for improved real-world health outcomes and decreased treatment costs for patients using reSET-O 1-3. reSET is for patients 18 years of age or older who are under the care of a clinician and is intended to increase abstinence from a patient’s substances of use during treatment, to increase retention of patients in outpatient treatment, and is used as a monotherapy for patients with substance use disorder. reSET-O is for patients 18 years of age or older who are under the care of a clinician and is intended to increase retention of patients in outpatient treatment and is used in combination with transmucosal buprenorphine for patients with opioid use disorder.
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.
About Prescription Digital Therapeutics (PDTs)
PDTs, such as Pear’s reSET-O digital treatment tool, 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 clinician 4,5. 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. reSET-O has been tested in real world use and randomized controlled trials with results published in peer-reviewed medical journals.
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 7 th 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.
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 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.
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.
1. 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.
2. 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.
3. 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
4. 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.
5. 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.
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KEYWORD: UNITED STATES NORTH AMERICA INDIANA MASSACHUSETTS CALIFORNIA
INDUSTRY KEYWORD: MENTAL HEALTH HEALTH
SOURCE: Pear Therapeutics, Inc.
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PUB: 02/17/2021 08:00 AM/DISC: 02/17/2021 08:01 AM
BOSTON & SAN FRANCISCO–(BUSINESS WIRE)–Feb 17, 2021–