- reSET-O® is the first and only FDA-authorized Prescription Digital Therapeutic (PDT) for the treatment of opioid use disorder (OUD).
- Data from more than 3000 patients prescribed and using reSET-O across the U.S. supports high real-world engagement and a positive association between product use and outcomes of reduced illicit opioid use and retention in treatment.
- Results demonstrate the ability for PDTs to enhance patient access to care and suggest that reSET-O may enhance outcomes for patients with OUD in real-world.
BOSTON & SAN FRANCISCO--(BUSINESS WIRE)--Pear Therapeutics, Inc. today announced publication in the peer-reviewed Journal of Current Medical Research and Opinion of real-world data from more than 3,000 patients using reSET-O®, the first and only FDA-authorized Prescription Digital Therapeutic (PDT) intended to increase retention of patients with OUD in outpatient treatment by providing cognitive behavioral therapy as an adjunct to outpatient treatment and contingency management. The real-world analysis evaluated patient engagement and usage of reSET-O and associated outcomes of opioid use and treatment retention of patients with OUD using buprenorphine medication-assisted treatment (MAT). The results demonstrate that reSET-O is readily and broadly used by patients with OUD and that real-world therapeutic engagement is positively associated with abstinence and retention in treatment. The findings show that reSET-O is a potentially valuable adjunct to buprenorphine MAT for patients with OUD.
“We are excited to share these data as we believe this is an important confirmation of the potential for reSET-O to improve clinical outcomes at scale and address the unmet needs of OUD treatment,” said Yuri Maricich, M.D., Chief Medical Officer at Pear Therapeutics and lead author of the paper. “This cohort of patients represents one of the largest datasets of community OUD treatment analyzed to date and robustly demonstrates the real-world impact of a PDT integrated into standard of care for patients with OUD.”
The real-world observational analysis was conducted in an all-comer population of 3,144 patients with OUD who were prescribed their first 12-week prescription for reSET-O. Substance use was evaluated as a composite of self-reports and urine drug screens. Summary of results:
- Patients came from 30 different states and represented a wide range of demographics (15.4% of individuals were between ages 19-29, 45.5% were between 30-39, 25% were between 40-49, 11.2% were between 50-59, and 2.9% were age 60 or older).
- Patients in the 40-49 age range had highest level of “Active” days of treatment.
- 80% of patients completed at least 25% of core module1 therapeutic doses (core modules: corresponds to minimal amount of behavioral treatment), 66% completed half of all core modules, and 49% completed all core modules; across entire cohort of patients.
- Patients used reSET-O throughout a 24-hour period, including before and after clinic hours.
- Over 70% of patients were retained in reSET-O treatment and continued to use their PDT during last 4 weeks.
- 91% of the patients were “responders”: meaning 80% of their self-reports and UDS were negative for illicit opioid use2.
- Subgroup analysis of patients using reSET-O appropriately (4 or more modules per week for the first 4 weeks) had 88.1% abstinence and 85.8% retention at weeks 9-123.
The results of this evaluation are consistent with similar positive findings of safety and effectiveness of reSET-O in randomized clinical trials and health economic analyses4-7. The paper titled “Real-World evidence for a prescription digital therapeutic to treat Opioid Use Disorder” was authored by members from Pear’s Research and Clinical Development and Commercial teams. The paper is available online by clicking here.
About Prescription Digital Therapeutics
PDTs 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 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.
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.
1 Modules are the dose unit with patients recommended to complete 4 modules per week.
2 Substance Use was evaluated as a composite of both UDS or self-report with imputation of missing data evaluated using multiple methods.
3 Abstinence was defined as last 4 weeks of treatment, composite of negative UDS or self-report. Retention was defined using a surrogate of use of the PDT during last 4 weeks of treatment.
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.
6 Maricich YM, Bickel WK, Marsch LA, Gatchalian K, Botbyl J, Luderer HF. Safety and Efficacy of a Prescription Digital Therapeutic as an Adjunct to Buprenorphine for Treatment of Opioid Use Disorder. Current Medical Research and Opinion. 2020. 10.1080/03007995.2020.1846022.
7Fulton 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.
Meara Murphy, Director of Corporate Communications