BOSTON and NASHVILLE, September 23, 2020 — Wellpath Community Care Centers and Pear Therapeutics, Inc. today announced availability of FDA-authorized prescription digital therapeutics (PDTs) with outpatient care, to elevate the nation’s battle against the substance and opioid use crisis. Wellpath Community Care Centers may now offer Pear’s reSET® and reSET-O® products to provide same day, single centered comprehensive medical and behavioral services with 24/7 access to optimize clinician delivered medication-assisted treatment (MAT) for optimal outcomes.
“After 25 years as an emergency room physician where I saw firsthand people die from drug overdose and families suffer due to this treatable disease, I joined Wellpath to save lives and make an impact on the millions who are affected by opioid addiction,” said Dr. Neil Schamban, President of Wellpath Community Care Centers. “One of the most impactful tools we all use, every day is our smartphone, and now, through a new generation of PDTs, we are able to elevate patient care by promoting deeper levels of engagement, accountability, communication, and education.”
Pear’s innovative FDA-authorized digital treatment supports patient and clinical success by placing evidenced-based therapy and treatment accountability in the palm of the patient’s hand. Through Pear’s reSET and reSET-O patients have access to algorithm-driven behavioral therapy, activities and self-reporting applications that are 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 for treatment of substance use disorder and opioid use disorder, respectively, which are adjunctive to outpatient counselling, may be used in conjunction with Wellpath’s outpatient clinician delivered care, including buprenorphine based MAT for opioid use disorder patients 18 years and older.
“Pear and Wellpath share commitment to integrate leading technologies into standard of care to combat the addiction crisis, and we believe our prescription digital therapeutics offer crucial treatment and support needed to help patients manage their recovery anytime, anywhere,” said Julia Strandberg, Chief Commercial Officer of Pear. “PDTs should soon become an essential component in the world of recovery, bringing a new level of remote support and connection to a patient’s recovery journey.”
About Wellpath Community Care Centers
Wellpath Community Care Centers (www.wellpathcarecenters.com) is a division of Wellpath. Wellpath holds patients at the center of everything we do. Our company promotes rigorous standards of care, nurtures innovation, and values compassionate service. With more than 15,000 clinicians and professionals in 33 states across the U.S. and Australia, Wellpath focuses on delivering high-quality medical and mental healthcare. Every day, Wellpath provides care for nearly 300,000 patients located in state hospitals, forensic treatment and civil commitment centers, Community Care Centers, as well as, local, state and federal correctional facilities. For more information about Wellpath, visit www.wellpathcare.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 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 full Clinician Brief Summary Instructions for reSET-O for more information.
About Pear Therapeutics
Pear Therapeutics, Inc. is the leader in prescription digital therapeutics. We aim 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 severe psychiatric and neurological conditions. Our lead product, reSET®, for the treatment of Substance Use Disorder, was the first prescription digital therapeutic to receive marketing authorization from the FDA to treat disease. Pear’s second product, reSET-O®, for the treatment of Opioid Use Disorder, received marketing authorization from the FDA in December 2018. For more information, visit us at www.peartherapeutics.com.
Wellpath Community Care Centers
Craig Diamond, Senior Vice President of Marketing
Meara Murphy, Director of Corporate Communications
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