Cove, which serves more than 30,000 people in the Tampa Bay community each year, will offer Pear’s reSET-O in English and Spanish.
BOSTON, August 03, 2022–(COMMERCIAL WIRE)–pear therapeutics, Inc. (Nasdaq: PEAR), a leader in the development and commercialization of software-based medicines called prescription digital therapies (PDTs), today announced that Cove Behavioral Health, Inc. (“Cove”) will provide access to authorized PDT FDA approval of Pear reSET-O® for the treatment of opioid use disorder (OUD). Cove, a comprehensive community-based provider of substance use disorder services, is rolling out reSET-O® at its centers in Tampa Bay, Florida for eligible patients. Funding is provided by the State Opioid Response (SOR) grant, administered by the Central Florida Behavioral Health Network, and part of the Substance Abuse and Mental Health Services Administration (SAMHSA) SOR grant program of the Department of US Health and Human Services for people in need of support for the prevention, treatment, and recovery of OUD.
reSET-O is an innovative response to the current opioid crisis in the United States, which is the deadliest ever.1.2 In the Tampa Bay area, the overdose rate is 23 out of 100,000 people. That rate is 9 percent higher than the rest of Florida and 50 percent higher than the national average.3
“We are proud to partner with the Department of Children and Families and the Behavioral Health Network of Central Florida to explore ways to better serve our patients. The reSET-O digital therapeutic pilot project is focused on helping our patients engage in treatment and improve patient outcomes. said Deanna Obregon, Executive Director of Behavioral Health.
“We are pleased that the Department of Children and Families has approved the use of reSET-O for people who need it to prevent relapse. This program is made possible through the use of SOR (State Opioid Response) funds,” said Linda McKinnon , Chief Executive Officer of the Behavioral Health Network of Central Florida.
Cove, which serves more than 30,000 people in the Tampa Bay community each year through treatment, prevention, education and outreach, will also help support its Hispanic patients by providing access to reSET-O in Spanish. Although rates of substance abuse among Hispanic Americans are similar to those of the general US population, there is a gap between Hispanics and the rest of the population when it comes to substance use disorder treatment. Some of the treatment disparities that occur within the Hispanic community can be addressed through increased availability of culturally sensitive treatment programs, including offering bilingual or exclusively Spanish-speaking activities.4
“Pear is pleased to partner with Cove at a time when it is more important than ever to provide people with OUD with access to evidence-based treatment,” said Julia Strandberg, chief commercial officer of Pear. “Our PDTs are innovative FDA-cleared therapies designed for patients to use remotely anytime, anywhere. We believe Cove and Pear can help expand access to care and benefit recovering patients” .
PDTs are a new therapeutic class that uses software to treat serious diseases. Like traditional medicines, PDTs are developed in an environment that complies with Good Manufacturing Practices; tested in randomized controlled trials to demonstrate safety and efficacy; FDA cleared; and is used under the supervision of a prescribing physician. Unlike traditional medicines, PDTs are designed to collect real-world data for use by prescribing physicians and for population health management by payers and health systems.
reSET -O Important Safety Information
Indications for use
The goal of reSET-O is to increase the 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 of age or older. most who are currently under a doctor’s supervision. reSET-O is indicated as a prescribed digital treatment by prescription only.
Important Safety Information:
Warnings: reSET-O is intended for patients whose primary language is English at a 7th grade reading level or higher, 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 using smartphone applications (apps). Physicians 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 any urgent or emergent information to their physician. In an emergency, patients should dial 911 or go to the nearest emergency room.
reSET-O is not intended for use as a stand-alone therapy for opioid use disorder (OUD). reSET-O is not a substitute for the care of a licensed physician 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 health care provider.
Patients with opioid use disorder experience mental health illnesses and comorbid medical problems at higher rates than the general population. Patients with opioid use disorder have higher baseline rates of suicidal ideation, suicide attempts, and completed suicide. Physicians should adopt the standard of care to monitor patients for medical problems and mental health conditions, including the risk of harm to others and/or themselves.
The long-term benefit of reSET-O has not been evaluated in studies lasting longer than 12 weeks (84 days) in the OUD population. The ability of reSET-O to prevent potential relapse after treatment discontinuation has not been studied.
About the SOR Program
The SOR program aims to address the opioid crisis by increasing access to medication-assisted treatment using FDA-approved medications for the treatment of opioid use disorder, reducing unmet need for treatment, and reducing overdose-related deaths. of opiates through the provision of prevention, treatment and recovery. Opioid use disorder (OUD) activities (including illicit use of prescription opioids, heroin, and fentanyl and fentanyl analogs). This program also supports evidence-based prevention, treatment, and recovery support services.
About pear therapeutics
Pear Therapeutics, Inc., traded on Nasdaq as PEAR, is the parent company of Pear Therapeutics (US), Inc. Pear is a leader in the development and commercialization of software-based medicines called prescription digital therapies (PDTs). Pear aims to redefine care through the widespread use of clinically validated software-based therapies to provide better outcomes for patients, smarter tracking and engagement tools for clinicians, and cost-effective solutions for payers. Pear has the first comprehensive platform for discovering, developing and delivering PDTs to patients and a portfolio of products and product candidates in therapeutic areas, including the first three PDTs with FDA disease treatment claims. Pear’s product, reSET®, for the treatment of substance use disorder, was the first PDT to receive marketing authorization from the FDA to treat the 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 the FDA’s traditional 510(k) pathway while simultaneously being reviewed through the FDA Software Precertification Pilot Program. For more information, visit Pera at www.peartherapeutics.com.
About Cove Behavioral Health
For nearly 50 years, Cove Behavioral Health has been here for the Tampa Bay community, helping people suffering from mental health and substance abuse disorders. Cove’s mission is to support the overall well-being of our community by providing accessible and compassionate behavioral health care. From mental health to substance use disorders, our trained and qualified doctors are here to help each person throughout their journey. Cove serves more than 30,000 people each year through treatment, prevention, education and outreach in Hillsborough and surrounding counties.
Álvarez, J., Jason, LA, Olson, BD, Ferrari, JR, & Davis, MI (2007). Substance abuse prevalence and treatment among Latinos and Latinas. Journal of Ethnicity in Substance Abuse, 6(2), 115-141.
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Senior Director of Corporate Communications
Cove Behavioral Health
Director of Development and Public Relations