BOSTON & BURLINGTON, Mass.--(BUSINESS WIRE)--Opioid use disorder (OUD) is often an isolating experience and with COVID-19-related social distancing, fostering recovery is challenging. Recover Together, Inc. (“Groups”), a leading outpatient treatment provider serving individuals with OUD across eight states, and Pear Therapeutics, Inc., the leader in prescription digital therapeutics (PDTs), today announced a combined effort to treat OUD patients by providing them with Pear’s innovative technology as well as Groups’ innovative approach to treatment.
The undertaking will pair Groups’ differentiated clinical, full-virtual model that leverages the benefits of medication-assisted treatment (MAT) and high quality group counseling, and Pear’s reSET-O®, an FDA-authorized PDT intended to increase retention of patients with OUD in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management.
“At Groups, individuals facing OUD see better recovery outcomes thanks in part to our model that leverages three pillars of care – medication, therapy and care navigation – in order to address the biological and underlying causes of addiction,” said Stephanie Stitt, Indiana Clinical Director at Groups. “Utilizing Pear’s reSET-O provides us with yet another outlet for treatment and helps us further enable our mission to expand access to innovative, multi-faceted opioid use disorder treatment options.”
Groups’ model helps members find and maintain long-term recovery by providing a supportive community that helps members solve underlying issues associated with opioid addiction. Pear’s reSET-O gives patients a 24/7 evidence-based tool to complement their remote or in-office outpatient addiction therapy provided by their care team. reSET-O provides 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.
“Pear and Groups Recover Together have a shared mission to serve substance use disorder and opioid use disorder populations with innovative approaches to extend care and aid the recovery process,” said Julia Strandberg, Chief Commercial Officer of Pear Therapeutics. “We are appreciative of the opportunity to work with Groups and we see opportunity for reSET-O to further improve care for patients with OUD.”
This news comes following recent data released by Groups Recover Together showing that their shift to all-virtual treatment during the pandemic has led to no demonstrable reduction in quality outcomes for members. Illicit opioid abstinence rate, retention rates, and member satisfaction were all measured on par or slightly better than the period before the pandemic, when care was delivered in an in-person setting. Similarly, Pear recently released multiple publications showing the potential for improved health outcomes and decreased treatment costs for patients using reSET-O1-3.
About Groups Recover Together
Groups Recover Together delivers opioid addiction recovery services that are proven to help individuals get their lives back on track. Groups provide fast, easy access to medication-assisted treatment (MAT) using Suboxone (buprenorphine), as well as a program designed to build a sense of community and accountability. In addition, members gain access to services through Groups' holistic care model, which is backed by the belief that long-term recovery from opioids is tied to social, behavioral and economic factors that aren't typically addressed in a traditional treatment model. Learn more at joingroups.com or follow us on Facebook, LinkedIn and YouTube.
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 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 clinician4,5. 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-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.
References:
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.
