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Mon. 6 Jun 2022, 8:45am ET Benzinga Press Releases
  • reSET® is the only FDA-authorized prescription digital therapeutic (PDT) for the treatment of substance use disorder (SUD), including alcohol, cannabis, cocaine, and stimulants
  • Results support the real-world value of reSET, demonstrating durable treatment outcomes and reductions in healthcare resource utilization
  • 6-month analysis is the first ever describing real-world health economic outcomes in patients undergoing treatment for multiple substance use disorders, and who were treated with reSET, demonstrating a 50% reduction in hospital encounters and >$3,500 per patient cost savings1

Pear Therapeutics, Inc. (NASDAQ:PEAR), the leader in developing and commercializing software-based medicines, called prescription digital therapeutics (PDTs), today announced a manuscript accepted for publication and available via pre-print of a real-world study demonstrating reduced resource utilization and associated costs for reSET®, the only FDA-authorized PDT for the treatment of substance use disorder (SUD), including alcohol, cannabis, cocaine, and stimulants.

Results from a real-world study of reSET showed a statistically significant reduction in overall hospital encounters and an estimated $3,591 reduction in per-patient costs in the six months after reSET initiation compared to a 6-month pre-reSET baseline.

This health economic study was accepted for publication and made available via pre-print by the international peer-reviewed journal Advances in Therapy.1

"Pear now has a continuum of evidence supporting our three FDA-authorized prescription digital therapeutics, including randomized controlled trials, real-world clinical data, and real-world health economic data," said Yuri Maricich, M.D., Chief Medical Officer and Head of Development at Pear Therapeutics. "This new study suggests a longer-term durability of outcomes for patients with substance use disorder, while also a reduction in the use of more costly health care resources in the first 6 months. As we strive to provide additional, flexible, and remote approaches to treatment for these patients and their communities, it's increasingly critical to understand the effectiveness, durability, and value PDTs bring to patients, clinicians, and payors."

The study evaluated real-world insurance claims from 101 adult patients with SUD treated with reSET, in the 6 months after initiation of reSET, and compared them to the claims six months prior to treatment and found:

  • Overall hospital encounters were reduced by 50% (IRR: 0.50; 95% CI: 0.37-0.67; P<0.001), a statistically significant decrease. Hospital encounters included reductions in:

- Inpatient stays (56% reduction; IRR: 0.44; 95% CI: 0.26-0.76; P=0.003).

- Partial hospitalizations (57% reduction; IRR: 0.43; 95% CI: 0.21-0.88; P=0.021).

- Emergency department visits (45% reduction; IRR: 0.55; 95% CI: 0.38-0.80; P<0.004).

  • An estimated $3,591 reduction in per-patient costs.1

The full paper is available online by clicking here.

reSET and its clinical intervention have been evaluated in randomized controlled trials, in real-world use and clinical outcomes, and now health economic outcomes.1-5

reSET Important Safety Information

Indications for Use:

reSET is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older, who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET is indicated as a 12-week (90 day) prescription-only treatment for patients with substance use disorder (SUD), who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse.

It is intended to:

  • increase abstinence from a patient's substances of abuse during treatment, and
  • increase retention in the outpatient treatment program.

Important Safety Information for Clinicians:

Warnings: reSET is intended for patients whose primary language is English with a reading level of 7th grade or above, and who have access to an Android/iOS tablet or smartphone. reSET is intended only for patients who own a smartphone and are familiar with use of smartphone apps (applications).

Clinicians should not use reSET to communicate with their patients about emergency medical issues. Patients should be clearly instructed not to use reSET 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 is not intended to be used as a stand-alone therapy for substance use disorder (SUD). reSET does not replace care by a licensed medical practitioner and is not intended to reduce the amount of face-to-face clinician time. reSET 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 substance use disorder experience mental health disease and co-morbid medical problems at higher rates than the general population. Patients with substance use disorder also have higher baseline rates of suicidal ideation, and suicide attempts, and suicide completion. Clinicians should engage in their normal care practices to monitor patients for medical problems and mental health disorders, including risk for harming others and/or themselves.

The long-term benefit of treatment with reSET on abstinence has not been evaluated in studies lasting beyond 12 weeks (90 days) in the SUD population. The ability of reSET to prevent potential relapse after treatment discontinuation has not been studied.

The effectiveness of reSET has not been demonstrated in patients currently reporting opioids as their primary substance of abuse.

This Press Release does not include all the information needed to use reSET safely and effectively. Please see the Clinician Brief Summary for reSET for more information.

About Pear Therapeutics

Pear Therapeutics, Inc., which is traded on Nasdaq as PEAR, is the parent company of Pear Therapeutics (US), Inc. Pear is the leader in developing and commercializing software-based medicines, called prescription digital therapeutics (PDTs). Pear aims to redefine care through the widespread use of 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 the first end-to-end platform to discover, develop, and deliver PDTs to patients and a pipeline of products and product candidates across therapeutic areas, including the first three PDTs with disease treatment claims from the FDA. Pear's product, reSET®, for the treatment of substance use disorder, was the first PDT to receive marketing authorization from the 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. Neel Shah, Fulton F. Velez, Sam Colman, Laura Kauffman, Charles Ruetsch, Kathryn Anastassopoulos & Yuri Maricich (2022). Real-world reductions in healthcare resource utilization over 6 months in patients with substance use disorders treated with a prescription digital therapeutic. Advances in Therapy. 2022; https://doi.org/10.6084/m9.figshare.19950266.v3.
  2. 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.
  3. Chaple M, Sacks S, McKendrick K, et al. (2016): A Comparative Study of the Therapeutic Education System for Incarcerated Substance-Abusing Offenders. The Prison Journal. 96(3):485-508. doi:10.1177/0032885516636858
  4. Xiong X, Braun S, Shafai G, Hare B, Luderer H, Stitzer M, Maricich Y. A Prescription Digital Therapeutic for Substance Use Disorder: Real World Engagement and Abstinence Patterns. Poster presented at: AcademyHealth; June 4-7, 2022; Washington, DC.
  5. Luderer H, Campbell A, Nunes E, Enman N, Xiong X, Gerwein R, Maricich Y. Engagement patterns with a digital therapeutic for substance use disorders: Correlations with abstinence outcomes. Journal of Substance Use Disorders. 132 (2021) 108585. https://doi.org/10.1016/j.jsat.2021.108585