Pear Therapeutics Announces Publication of Real-World Data Showing Improved Clinical Outcomes with a Subsequent Prescription of reSET-O® for Patients with Opioid Use Disorder

Pear Therapeutics, Inc., today announced publication of real-world data evaluating the impact of reSET-O, the first and only FDA-authorized Prescription Digital Therapeutic (PDT) for the treatment of opioid use disorder (OUD), on patients treated for 24 weeks. The analysis, published in the peer-reviewed journal Hospital Practice, provides real-world evidence that 24 weeks of reSET-O treatment (i.e., patients who received an initial prescription and a "refill") for OUD is associated with improved outcomes, high levels of treatment retention, and fewer hospital encounters compared to 12 weeks of reSET-O treatment (i.e., single prescription of reSET-O). Prior publications of real-world use showed that 12 weeks of reSET-O treatment (a single prescription) is associated with increased retention, reduced substance use, a reduction in total healthcare costs, and improved quality-adjusted life year (QALY) gains.^2-8

"We've previously found that 12-weeks of reSET-O treatment (one prescription) has high rates of patient use and the potential to enhance health outcomes and reduce healthcare costs. This new analysis, the first real-world evaluation of patients treated for 24 consecutive weeks with reSET-O, demonstrates that patients both engage with a refill prescription, and that the engagement is associated with improvements in clinical and health economic outcomes, including abstinence, retention in treatment, and reduction in emergency room, in-patient, and intensive care unit stays compared to patients not treated, as well as those treated for 12 weeks," said Yuri Maricich, M.D., Chief Medical Officer of Pear Therapeutics. "As OUD overdose rates and OUD incidence worsens across the country, these findings are timely as they continue to support reSET-O as a tool help patients stay in recovery, while potentially reducing sizeable healthcare spend."

This real-world analysis evaluated patient engagement with reSET-O, as well as rates of opioid use and retention among a population of patients prescribed a second prescription and treated for 24 weeks. Of the 3,817 patients with OUD from 12 states in the U.S. who filled an initial 12-week reSET-O prescription (12-week cohort), 643 patients were prescribed a second, 12-week "refill," for a total treatment duration of 24 weeks (24-week cohort). Patients evaluated were in outpatient treatment and were prescribed buprenorphine at clinician-determined doses, routes of administration and regimens.

• In the 24-week cohort, 94.4% met the responder rate of being abstinent for at least 80% of the weeks of treatment. Abstinence was measured based on negative UDS or self-reports. 91.4% of patients were retained in treatment at the end of the second prescription period (weeks 21-24 of 24).
• Analysis of health care claims data showed that patients treated for 24 weeks with reSET-O had an additional 27% decrease in healthcare utilization rates compared to those who completed 12 weeks of treatment.
• Previous studies have shown a single prescription of reSET-O in conjunction with treatment-as-usual (TAU - transmucosal buprenorphine, face-to-face counseling, and contingency management) to be more effective and less costly compared to TAU alone over 12 weeks, 6 months, and 9 months.
• The data also reveal a positive association between engagement with reSET-O early in treatment and abstinence in the final four weeks of treatment (weeks 21-24 of 24), suggesting the opportunity to further develop predictors of long-term treatment success.
• Taken together with prior publications, these results suggest that reSET-O can provide clinical and economic benefit, that patients continue to have high-rates of engagement through 24 weeks of treatment, and that benefit can by enhanced significantly by a "refill" prescription of the PDT.

The full paper is available online by clicking here.

These results are further supported by recently published real-world clinical and economic data showing the potential for improved health outcomes and decreased treatment costs for patients using reSET-O.^2-8

About OUD
In recent years, OUD has been responsible for approximately two out of every three deaths related to substance use disorder (SUD).⁹ 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.^10,11The ultimate treatment goal of patients with OUD is sustained abstinence and recovery of their lives.¹² 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.¹³

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).

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 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.

References:
1. Anderson KE, Saloner B, Eckstein J, Chaisson CE, Scholle SH, Niles L, Dy S, Alexander GC. Quality of Buprenorphine Care for Insured Adults With Opioid Use Disorder. Med Care. 2021 May 1;59(5):393-401. doi: 10.1097/MLR.0000000000001530. PMID: 33734194; PMCID: PMC8026663.
2. 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.
3. 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.
4. 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
5. Yuri A. Maricich, Warren K. Bickel, Lisa A. Marsch, Kirstin Gatchalian, Jeffrey Botbyl & Hilary F. Luderer (2020) Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder, Current Medical Research and Opinion, DOI: 10.1080/03007995.2020.1846022.
6. Fulton F. Velez, Hilary F. Luderer, Robert Gerwien, Benjamin Parcher, Dylan Mezzio & Daniel C. Malone (2021) Evaluation of the cost-utility of a prescription digital therapeutic for the treatment of opioid use disorder, Postgraduate Medicine, DOI: 10.1080/00325481.2021.1884471
7. Fulton F. Velez, Charles Ruetsch & Yuri Maricich (2021) Evidence of long-term 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: 10.1080/14737167.2021.1939687
8. Fulton F. Velez & Daniel C. Malone (2021) Cost-Effectiveness Analysis of a Prescription Digital Therapeutic for the Treatment of Opioid Use Disorder, Journal of Market Access & Health Policy, 9:1, DOI: 10.1080/20016689.2021.1966187
9. 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).
10. 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.
11. 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
12. 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.
13. 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.