BOSTON--(BUSINESS WIRE)--
(Nasdaq: PEAR), the leader in developing and commercializing software-based medicines called prescription digital therapeutics (PDTs), today announced data from a real-world analysis of engagement, substance use, and retention patterns in patients diagnosed with substance use disorder who use alcohol and were treated with reSET. The real-world data were presented during the 33rd meeting of the American Association of Addiction Psychiatry held from December 8-11, 2022, in Naples, FL.
“Alcohol use disorder (AUD) currently affects about 28 million people in the United States,1 with approximately 140,000 people dying each year from alcohol-related causes.3 However, barriers to evidence-based AUD treatments exist, including lack of trained clinicians, access to specialty facilities and patient attrition,” said Yuri Maricich, MD, MBA, Chief Medical Officer, Pear Therapeutics. “These data are an encouraging sign that reSET can be helpful to a large and underserved patient population.”
The real-world observational study evaluated 548 patients with alcohol-related disorders from 28 states who were treated with reSET over 12 weeks. The primary endpoint was engagement with reSET (lessons completed) throughout the prescription, and activity was also assessed as any use of reSET during a given week. The secondary endpoint was abstinence as measured by a composite of self-report and urine drug screens.
Highlights presented include:2
- 69.7% of patients (n=548) were retained in treatment during weeks 9-12 (last 4 weeks)
- 59% of patients (n=548) were abstinent (during weeks 9-12): no substance use as measured by a composite of self-report and drug testing
These data highlight benefits from reSET, which is indicated to treat addiction to cannabis, cocaine, and stimulants and alcohol when used with another substance.
For more information, please view the poster abstract .
Pear, which received Breakthrough Device Designation from FDA for an AUD-only indication for reSET, has not yet received marketing authorization for an AUD-only indication.
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:
Warnings: reSET is intended for patients whose primary language is English or Spanish 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 safely and effectively. Please see the 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 .
References:
- SAMHSA. Key substance use and mental health indicators in the United States: Results from the . . Published 2020. Accessed December 8, 2022.
- Luderer H, Sullivan MA, Xiong X, Maricich Y. A prescription digital therapeutic for substance use disorder: real-world engagement and abstinence patterns in patients diagnosed with alcohol-related disorders. Poster 71. .
- Centers for Disease Control & Prevention. Alcohol and Public Health: Alcohol-Related Disease impact. Retrieved from Accessed December 8, 2022.
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