Pear Therapeutics Presents Real-World Clinical Data Assessing Engagement and Abstinence in Patients with Alcohol Use Disorders Using reSET® at AAAP
15 Décembre 2022 - 2:00PM
Business Wire
- Alcohol is the most common substance use disorder (SUD),
representing 70% of the more than 40 million people with SUD1
- New data from real-world use of reSET® demonstrate patients who
use alcohol exhibit robust engagement, retention, and
abstinence
Pear Therapeutics, Inc. (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 here.
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 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:
- SAMHSA. Key substance use and mental health indicators in the
United States: Results from the 2020 Survey on Drug Use and Health.
https://www.samhsa.gov/data/. 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.
https://aaap.societyconference.com/conf/#sessions/conf10004.
- Centers for Disease Control & Prevention. Alcohol and
Public Health: Alcohol-Related Disease impact. Retrieved from
https://nccd.cdc.gov/DPH_ARDI/Default/Report.aspx?T=AAM&P=612EF325-9B55-442B-AE0C-789B06E3A8D5&R=C877B524-834A-47D5-964D-158FE519C894&M=DB4DAAC0-C9B3-4F92-91A5-A5781DA85B68&F=&D=
Accessed December 8, 2022.
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version on businesswire.com: https://www.businesswire.com/news/home/20221215005368/en/
Media and Investors: Meara Murphy Senior Director, Corporate
Communications meara.murphy@peartherapeutics.com
Golin golinpear@golin.com
Pear Therapeutics (NASDAQ:PEAR)
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