Pear+Therapeutic, Inc. (Nasdaq: PEAR), the leading developer and marketer of software-based drugs known as digital prescription therapies (PDTs), today announced that Cove Behavioral Health, Inc. (“Cove”) will provide access Pear’s FDA-cleared PDT reSET-O® for the treatment of opioid use disorder (OUD). Cove, a comprehensive community service provider for substance use disorders, is implementing 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 is part of the U.S. Department of Health’s Substance Abuse and Mental Health Services Administration (SAMHSA) SOR grant program and social services for people in need. to help prevent, treat and recover from TOU.
reSET-O is an innovative response to America’s current opioid crisis, which is the deadliest it has ever been.1.2 In the Tampa Bay area, the overdose rate is 23 per 100,000 people. This rate is 9% higher than the rest of Florida and 50% higher than the national average.3
“We are proud to partner with the Department of Children and Families & Central Florida Behavioral Health Network to explore ways to better serve our patients. The reSET-O Digital Therapeutics Pilot aims to help our patients engage in treatment and improve patient outcomes,” said Deanna Obregon, Chief Executive Officer of Behavioral Health.
“We are pleased that the Ministry of Children and Families has approved the use of reSET-O for those in need to prevent relapse. This program is made possible through the use of SOR (State Opioid Response) funding,” said Linda McKinnon, Executive Director of the Central Florida Behavioral Health Network.
Cove, which serves more than 30,000 people in the Tampa Bay community each year through treatment, prevention, education and awareness, will also help support its Hispanic patients by providing access to reSET-O in Spanish. . Although rates of substance abuse among Hispanics 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 treatment for substance abuse disorders. substance use. Some of the treatment disparities that occur within the Hispanic community can be addressed through the greater availability of culturally appropriate treatment programs, including the provision of bilingual or Spanish-only activities.4
“Pear is thrilled to team up with Cove at a time when providing people with OUD with access to evidence-based treatments is more important than ever,” said Julia Strandberg, Chief Commercial Officer of Pear. “Our PDTs are innovative, FDA-cleared therapeutic products designed to be used remotely, anytime, anywhere by patients. 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 used under the supervision of a prescribing clinician. Unlike traditional drugs, PDTs are designed to collect real-world data for use by prescribing clinicians and for population health management by payers and health systems.
Important Safety Information
Indications for use
reSET-O aims 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 management emergency department, for patients 18 years of age or older who are currently under the supervision of a clinician. reSET-O is indicated as a digital treatment by prescription only.
Important safety information:
Warnings: reSET-O is intended for patients whose primary language is English with a reading level of Grade 7 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 the use of smartphone applications (apps). 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 any urgent or emerging information to their clinician. In an emergency, patients should call 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 does not replace 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 healthcare provider.
Patients with opioid use disorders suffer from comorbid mental illnesses and medical conditions at higher rates than the general population. Patients with opioid use disorder have higher baseline rates of suicidal ideation, suicide attempt, and suicide completion. Clinicians should apply standards of care to monitor patients for medical conditions and mental illnesses, including risk of harm to others and/or themselves.
The long-term benefit of reSET-O has not been evaluated in studies longer than 12 weeks (84 days) in the UUD population. The ability of reSET-O to prevent potential relapse after stopping treatment has not been studied.
About the SOR program
The SOR program aims to address the opioid crisis by increasing access to drug treatment using FDA-approved drugs for the treatment of opioid use disorders, reducing unmet treatment needs and reducing opioid overdose deaths through prevention, treatment and recovery. activities related to opioid use disorder (OTD) (including illicit use of prescription opioids, heroin, fentanyl and fentanyl analogues). This program also supports evidence-based prevention, treatment and recovery support services.
About Pear Therapeutics
Pear Therapeutics, Inc., which is listed on Nasdaq as PEAR, is the parent company of Pear Therapeutics (US), Inc. Pear is the leader in the development and commercialization of software medicines, called digital prescription therapies ( PDT). Pear aims to redefine care through the widespread use of clinically validated software therapies to provide better patient outcomes, 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 all therapeutic areas, including the first three PDTs with disease treatment claims from the FDA. Pear’s product, reSET®, for the treatment of substance use disorders, was the first PDT to receive marketing clearance from the FDA to treat the condition. Pear’s second product, reSET-O®, for the treatment of opioid use disorder, was the first PDT to receive the 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 under the FDA’s software precertification pilot program. FDA. For more information, visit Pear at www.peartherapeutics.com.
About Cove Behavioral Health
For nearly 50 years, Cove Behavioral Health has been there for the Tampa Bay community, helping people with addictions and mental health issues. 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 clinicians are here to help each person along their journey. Cove serves more than 30,000 people each year through treatment, prevention, education and outreach in Hillsborough and surrounding counties.
Alvarez, J., Jason, LA, Olson, BD, Ferrari, JR, and 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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