Pear’s reSET-O® is the first US FDA-authorized Prescription Digital Therapeutic for patients with Opioid Use Disorder
BOSTON & GREENVILLE, SC – Adults struggling with Opioid Use Disorder (OUD) will have access to a groundbreaking Prescription Digital Therapeutic (PDT) thanks to a collaboration between Crossroads Treatment Centers and Pear Therapeutics, Inc. Crossroads Treatment Centers, the parent company of ARS Treatment Centers, will be implementing Pear’s reSET-O® PDT in 38 of its treatment centers across western Pennsylvania this month, with plans to roll out the product across the company’s 10-state footprint throughout 2020.
“As a national leader in opioid treatment, we are committed to bringing best-in-class treatment options to those struggling with Opioid Use Disorder. reSET-O is a complementary therapy to our outpatient treatment program that has already shown to be successful in keeping more patients on the path to recovery,” Rupert McCormac, M.D., CEO of Crossroads Treatment Centers, said. “Our collaboration with Pear means more people will get access to the support they need to fight opioid addiction.”
reSET-O is a 12-week prescription treatment that includes algorithmically-driven cognitive behavioral therapy, fluency training, and contingency management. The product is intended to be used in conjunction with buprenorphine-based Medication-Assisted Treatment for the treatment of OUD in patients 18 years or older currently under the care of a clinician.
reSET-O also includes a Clinician Dashboard. The dashboard helps clinicians monitor their patients’ progress toward recovery, including patient-reported substance use, cravings triggers and buprenorphine use.
The efficacy of reSET-O was evaluated in a pivotal, randomized trial of 170 patients seeking treatment for OUD, who received supervised buprenorphine treatment paired with a behavior therapy program, either with or without the addition of the therapeutic content of reSET-O. The clinical trial showed that the digital therapeutic produced an overall retention rate of 82.4 percent through the end of 12 weeks of treatment compared with 68.4 percent overall retention rate for patients who did not use reSET-O.
ARS Treatment Centers is a category leader in Office-Based Opioid Treatment (OBOT) with a family of dedicated doctors, nurse practitioners, counselors and professionals that use proven individualized treatment plans (medication, counseling, and toxicology services) to provide the highest quality of professional care.
reSET-O® 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.
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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.
The reSET-O® prescription mobile medical application is a 12-week (84-day) software application. It is limited to persons with a valid prescription from their licensed provider. reSET-O® is intended to be used to increase retention of patients with Opioid Use Disorder in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management to patients currently under clinician care.
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.
About Crossroads Treatment Centers
Headquartered in Greenville, S.C., Crossroads Treatment Centers is a national leader in outpatient treatment for Opioid Use Disorder. Crossroads is also the parent company of ARS Treatment Centers. Together the two brands operate more than 90 addiction treatment facilities in 10 states. With proven, individualized treatment plans (medication, counseling, and toxicology services) the family of dedicated doctors, nurse practitioners, counselors, and professionals at Crossroads and ARS are able to provide the highest quality of professional care to over 22,000 patients. Understanding that the opioid epidemic demands aggressive implementation of critical resources to increase patient access to treatment, Crossroads has committed to opening more than 30 new treatment facilities, under both the Crossroads and ARS brands, by the end of 2020.