BOSTON--(BUSINESS WIRE)--Pear Therapeutics, Inc., the leader in prescription digital therapeutics (PDT), today announced poster and oral presentations on new clinical trial data for reSET® for the treatment of Substance Use Disorder, and reSET-O™ for the treatment of Opioid Use Disorder. The data will be presented at the American Academy of Addiction Psychiatry (AAAP) 29th Annual Meeting and Scientific Symposium.
“More than 31 million people in the U.S. currently suffer from drug use disorders, including opioid addiction1. We believe prescription digital therapeutics like reSET and reSET-O can meaningfully address this epidemic, as supported by the clinical outcomes we’re sharing at this year’s AAAP meeting,” said Yuri Maricich, M.D., M.B.A., Chief Medical Officer of Pear Therapeutics. “Prescription digital therapeutics provide a unique opportunity to continually study and learn from data, which means that these treatments can evolve over time based on real-world use.”
Dr. Maricich will present new topline data on reSET-O during a presentation titled, “Efficacy and Safety of reSET-O™ Prescription Digital Therapeutic for Opioid Use Disorder” on Friday, December 7 from 3:15 pm – 4:15 pm ET. The data demonstrate improvements in treatment retention when used in conjunction with standard of care buprenorphine. The study also evaluated urine drug screen data during the course of study participation. These data underscore reSET-O as a promising tool for combatting the opioid crisis. reSET-O is not yet available in the U.S. and is under 510(k) review by FDA with Breakthrough Designation.
In addition, Pear Therapeutics will have two posters on display:
- “Safety and Efficacy of reSET® Prescription Digital Therapeutic for Substance Use Disorder” presents new statistical analysis of the 12-week, multi-site randomized study that supported the FDA’s September 2017 authorization of reSET. Participants were randomized to receive standard of care treatment or standard of care plus reSET. In the cohort analysis of nearly 400 patients who reported alcohol, cocaine, cannabis, or stimulants as their primary substance of abuse, a more than two-fold increase in abstinence and a significant increased retention in treatment was observed in the group receiving reSET. The use of reSET had a highly significant impact on abstinence for participants who were non-abstinent at study start.
- “A Digital Therapeutic for SUD, reSET®, Demonstrates a Correlation Between Dose and Treatment Outcomes” highlights the relationship between reSET engagement and clinical outcomes based on data gathered and analyzed during the same 12-week study. A strong correlation between module completion (dose) and abstinence was observed. A strong correlation between module completion and appointment attendance was similarly observed. Individuals who completed 24 or more modules (i.e. recommended dose) in the first six weeks of treatment were more than three times more likely to complete the entire 12 weeks than patients who completed fewer than 18 modules. The data demonstrate a significant neurobehavioral impact of reSET and suggest that dose/engagement with reSET may predict treatment outcomes.
Posters will be on display from Saturday, December 8 at 4:30 pm until Sunday, December 9 at 10:00 am ET. For more information, please visit the AAAP website at https://www.aaap.org/annual-meeting.
About Pear Therapeutics
Pear Therapeutics 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. Pear has a pipeline of products and product candidates across therapeutic areas, including severe psychiatric and neurological conditions. Our lead product, reSET®, treats Substance Use Disorder and was the first prescription digital therapeutic to receive marketing authorization from the FDA to treat disease. Pear’s second product, reSET-O™, for the treatment of Opioid Use Disorder (OUD), is under FDA review with Breakthrough Designation. For more information, visit us at www.peartherapeutics.com.
1 World Health Organization. World Drug Report 2018. Available at: https://www.unodc.org/wdr2018/.