BOSTON & SAN FRANCISCO–(BUSINESS WIRE)–Pear Therapeutics, Inc. today announced an effort to provide health system leaders with evidence-based data on best practices for implementation of prescription digital therapeutics (PDTs) for substance use disorder (SUD) and opioid use disorder (OUD) in primary care.
The study, led by researchers at Kaiser Permanente Washington Health Research Institute, will evaluate different approaches to implementing Pear’s FDA-authorized PDTs, reSET® and reSET-O®, for the treatment of SUD and OUD, respectively, into every day primary care practice. The project will evaluate the effectiveness and sustainability of clinician-facing and patient-facing implementation strategies for integrating PDTs into care at Kaiser Permanente Washington primary care clinics.
The National Institute on Drug Abuse provided funding for the study.
The work began in March as a pilot project in two primary clinics, with plans to roll out at 28 more clinics across Washington later in the year. It is expected to include over 1,000 patients. A multidisciplinary team of implementation science researchers, clinical trialists, social workers, doctors, designers, biostatisticians, and health economists are collaborating on the project.
“More than 20 million people in the U.S. suffer from substance use disorders, yet researchers and health systems struggle with how to reach this large number of patients in need of effective treatment,” said Yuri Maricich, M.D., Chief Medical Officer at Pear Therapeutics. “Our work aims to provide the data and strategies that health systems need to distill best practices of implementing prescription digital therapeutics to keep more people on the path to recovery. By extending the reach of this treatment option, we could help address the lack of access and barriers to treatment for SUDs and neurobehavioral treatment alongside transmucosal buprenorphine prescribing for OUD in the primary care setting.”
Pear’s innovative PDTs support patient and clinical success by placing evidence-based therapy and treatment accountability in the palm of the patient’s hand. With Pear’s reSET and reSET-O patients have access to algorithm-driven behavioral therapy, activities, and self-reporting applications designed to drive engagement and improve long-term outcomes. Using the Pear platform, clinicians can track patient treatment compliance and progress. Pear’s reSET and reSET-O are adjunctive to outpatient clinician-delivered care, in SUD and OUD alongside transmucosal buprenorphine-based medication-assisted treatment (MAT) in patients 18 years and older, respectively.
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.
This Press Release does not include all the information needed to use reSET safely and effectively. Please see the full 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 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 full Clinician Brief Summary Instructions for reSET-O for more information.