BOSTON--(BUSINESS WIRE)--Pear Therapeutics, Inc. (Nasdaq: PEAR), the leader in developing and commercializing software-based medicines called prescription digital therapeutics (PDTs), today announced the company will host an educational Vision Session at the Rx and Illicit Drug Summit (Rx Summit), April 18-21 in Atlanta, GA. The Rx Summit is the largest annual gathering for global stakeholders to address the opioid and addiction epidemic and share best practices and strategies for prevention, treatment, and recovery.
“The US has seen an unprecedented increase in drug use and overdose deaths during the COVID-19 pandemic, exacerbated by challenges for people living in isolation or with few viable treatment resources available,” said Yuri Maricich, MD, MBA, Chief Medical Officer, Pear Therapeutics. “At this year’s Rx Summit, we look forward to discussing with our clinician panelists how PDTs can address health equity and health care disparities, potentially improve treatment outcomes, and expand access to proven treatment options for people living with addiction.
The Vision Session, titled “Recovery is in Your Hands: How Access to Digital Therapeutics Can Drive Outcomes” will feature a presentation and panel discussion including decision makers who are leading the way to provide access to PDTs. The session will highlight how PDTs for substance use disorder (SUD) and opioid use disorder (OUD) are working to improve access to care for patients, including underserved populations, explore clinical outcomes and real-world engagement data, and discuss how various organizations and key decision makers can pave the way with digital treatments to treat serious diseases.
Panel participants will include:
- Shawn Ryan, MD, MBA; President and Chief Medical Officer, BrightView Health
- Timothy Aungst, PharmD; Associate Professor at MCPHS University, Worcester, MA, and Clinical Pharmacist in home health care.
- Sonji Adams, LPCC, LCADC; Behavioral Health Coordinator, Mountain Comprehensive Health Corporation
- George Kitchens, RPh; CEO, Artia Solutions and Former Pharmacy Services Bureau Chief, FL Medicaid
Pear Therapeutics is the category creator and leader in PDTs, having developed the first and only FDA-authorized PDTs to treat SUD and OUD. PDTs are a new therapeutic class that uses software to treat serious disease. Like traditional medicines, PDTs are developed in a GMP-compliant environment, tested in randomized controlled trials to demonstrate safety and effectiveness, evaluated for authorization by regulators like FDA, and used under the supervision of a prescribing clinician. Unlike traditional medicines, PDTs are designed to collect real world data for use by prescribing clinicians and for population health management by payers and health systems.
To learn more about the Session, which will take place on Tuesday, April 19 at 8:00 ET in International Ballroom A-D, please visit www.rx-summit.com/agenda.
For more information on Pear’s PDTs for SUD and OUD, visit www.resetforrecovery.com.
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.
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.
reSET-O Important Safety Information
Indications for Use:
reSET-O prescription digital therapeutic is a 12-week (84 day) software application 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 digital therapeutic.
Important Safety Information for Clinicians:
Warnings: reSET-O 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-O is intended only for patients who own a smartphone and are familiar with use of smartphone apps (applications).
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.
reSET-O is not intended to be used as a stand-alone therapy for Opioid Use Disorder (OUD). reSET-O does not replace care by a licensed medical practitioner and is not intended to reduce the frequency or duration of in-person therapy. 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.
Patients with opioid use disorder experience mental health disease and co-morbid medical problems at higher rates than the general population. Patients with opioid use disorder have higher baseline rates of suicidal ideation, and suicide attempts, and suicide completion. Clinicians should undertake standard of care to monitor patients for medical problems and mental health disease, including risk for harming others and/or themselves.
The long-term benefit of reSET-O has not been evaluated in studies lasting beyond 12 weeks (84 days) in the OUD population. The ability of reSET-O to prevent potential relapse after therapy discontinuation has not been studied.
This Press Release does not include all the information needed to use reSET-O safely and effectively.
Please see the Clinician Brief Summary Instructions for reSET-O for more information.
