• reSET-O^®, the first and only FDA-authorized Prescription Digital Therapeutic (PDT) for the treatment of opioid use disorder (OUD).
• New publication analyzed real-world claims data from commercial patients prescribed a single 84-day course of reSET-O.
• Data showed utilization of reSET-O for 84 days was associated with a significant decrease in inpatient stays and fewer visits to the emergency room, as well as multiple other reductions in healthcare utilization over a 9-month period.
• Data showed inpatient stays and emergency room visits were lower in months 6 to 9 compared to the first 6 months post-reSET-O initiation, suggesting a possible long-term stabilization of patient outcomes.

Pear Therapeutics, Inc. today announced results from an extended retrospective analysis of real-world data analyzing healthcare resource utilization for reSET-O®, the first and only FDA-authorized Prescription Digital Therapeutic (PDT) for the treatment of opioid use disorder (OUD). Results from a nine-month real-world data analysis show a continued long-term reduction in costly healthcare utilization categories including inpatient (IP) stays and emergency department (ED) visits in patients with OUD. The analysis, published in the peer-reviewed journal Expert Review of Pharmacoeconomics & Outcomes Research, suggests a possible durability of the reSET-O treatment effect and a long-term stabilization of the clinical trajectory for patients in recovery from OUD, and indicate a strong potential for the cost effectiveness of reSET-O in real-world care settings.

“These findings show how reSET-O can improve total quality of care while reducing the main healthcare cost drivers in OUD,” said Corey McCann, M.D., Ph.D., President and CEO of Pear Therapeutics. “Opioid misuse and overdoses continue to be at epidemic levels in the United States, and patients need access to durable evidence-based behavioral interventions that keep them in recovery, while reducing healthcare costs. In this critical time, patients need more flexible approaches to treatment that can be delivered remotely and that can scale-up during times of increased demand for behavioral health and substance use recovery service.”

In a previous retrospective real-world claims analysis, healthcare resource utilization was evaluated up to 6 months after patients initiated treatment with reSET-O. Results from this study, published in Expert Review of Pharmacoeconomics & Outcomes Research, showed that reSET-O was associated with fewer inpatient, intensive care unit, emergency department, and other clinical encounters, compared to the six months prior to reSET-O initiation.

This study serves as an extended analysis assessing the durability of effect of reSET-O over a 9-month period post-initiation of reSET-O in a larger OUD patient population (n=444). Further reductions in IP stays, ED visits, and other clinical encounters were observed in months 6 to 9 compared to the first 6 months post-index (i.e., post-reSET-O initiation). These results support the association of reSET-O with reduced healthcare utilization and long-term stabilization of patient outcomes.

Specific results from the extended analysis for Real-world reduction in healthcare resource utilization following treatment of opioid use disorder with reSET-O, a novel prescription digital therapeutic:

• IP stays and ED visits decreased by 50% and 27%, respectively in the 9-month post-index period versus the 9-month pre-index period (i.e., pre-reSET-O initiation).

• Quarterly reductions in healthcare utilization were sustained in the 9-month analysis. A total of 18 IP stays and 79 ED visits were recorded during months 6 to 9, versus 32 IP stays and 97 ED visits in months 3 to 6.

• Utilization of drug testing and adjunct counseling sessions decreased in months 6 to 9 (drug tests: 1,905; counseling sessions: 1,309) compared to the 6-month pre-index (drug tests: 2,192; counseling sessions: 1,421) and post-index periods (drug tests: 2,028; counseling sessions: 1,373), suggesting a possible stabilization of patient outcomes 9 months following initiation of reSET-O.

• Buprenorphine adherence increased from 74% to 82% (pre- vs. post-index), suggesting that use of reSET-O is associated with increased medication use.

The initial paper is available online by clicking here.

About OUD

In recent years, OUD has been responsible for approximately two out of every three deaths related to substance use disorder (SUD).¹ The cost of OUD to the U.S. healthcare system alone is estimated at approximately $90 billion per year, and is largely driven by excess hospital and emergency department encounters.^2,3 The ultimate treatment goal of patients with OUD is sustained abstinence and recovery of their lives.⁴ However, less than 35% of adults with OUD in 2019 received treatment for opioid use in the past year, highlighting the need for expanded access to comprehensive OUD treatment.⁵

reSET-O Important Safety Information

Indications for Use:

reSET-O prescription digital therapeutic is a 12-week (84 day) software application 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 digital therapeutic.

Important Safety Information for Clinicians:

Warnings: reSET-O is intended for patients whose primary language is English with a reading level of 7^th grade or above, 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). 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.

reSET-O is not intended to be used as a stand-alone therapy for Opioid Use Disorder (OUD). reSET-O does not replace care by a licensed medical practitioner and is not intended to reduce the frequency or duration of in-person therapy. 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.

Patients with opioid use disorder experience mental health disease and co-morbid medical problems at higher rates than the general population. Patients with opioid use disorder have higher baseline rates of suicidal ideation, and suicide attempts, and suicide completion. Clinicians should undertake standard of care to monitor patients for medical problems and mental health disease, including risk for harming others and/or themselves.

The long-term benefit of reSET-O has not been evaluated in studies lasting beyond 12 weeks (84 days) in the OUD population. The ability of reSET-O to prevent potential relapse after therapy discontinuation has not been studied.

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.

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. reSET®, for the treatment of substance use disorder, was the first digital therapeutic to receive marketing authorization from the FDA to treat disease. Pear’s reSET-O® is indicated for the treatment of opioid use disorder and Somryst® is indicated for the treatment of chronic insomnia. Pear has a pipeline of products and product candidates across therapeutic areas, including severe psychiatric and neurologic conditions. For more information, visit us at www.peartherapeutics.com.

References:

1. Jalal H, Buchanich JM, Roberts MS, et al. Changing dynamics of the drug overdose epidemic in the United States from 1979 through 2016. Science. 2018 Sep 21;361(6408).
2. Florence CS, Zhou C, Luo F, et al. The Economic Burden of Prescription Opioid Overdose, Abuse, and Dependence in the United States, 2013. Medical care. 2016;54(10):901-906.
3. The Council of Economic Advisers. The underestimated cost of the opioid crisis 2017. Available from: https://static.politico.com/1d/33/4822776641cfbac67f9bc7dbd9c8/the-underestimated-cost-of-the-opioid-crisis-embargoed.pdf.
4. Lofwall MR, Walsh SL, Nunes EV, et al. Weekly and Monthly Subcutaneous Buprenorphine Depot Formulations vs Daily Sublingual Buprenorphine With Naloxone for Treatment of Opioid Use Disorder: A Randomized Clinical Trial. JAMA Intern Med. 2018;178(6):764-773.
5. Food & Drug Administration. Opioid use disorder: endpoints for demonstrating effectiveness of drugs for medication‐assisted treatment guidance for industry. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/opioid-use-disorder-endpoints-demonstrating-effectiveness-drugs-medication-assisted-treatment. Accessed September 29, 2020.

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