BOSTON–(BUSINESS WIRE)–Pear Therapeutics, Inc. (Nasdaq: PEAR), the leader in developing and commercializing software-based medicines called prescription digital therapeutics (PDTs), announced today that Cove Behavioral Health, Inc. (“Cove”) will provide access to Pear’s FDA-authorized PDT reSET-O® for the treatment of opioid use disorder (OUD). Cove, a comprehensive community-based substance use disorder service provider, is implementing reSET-O® in its centers in Tampa Bay, Florida for eligible patients. Funding is provided by the State Opioid Response (SOR) grant, administered by Central Florida Behavioral Health Network, and part of the U.S. Department of Health and Human Services’ Substance Abuse and Mental Health Services Administration (SAMHSA) SOR grant program for people in need of prevention, treatment and recovery support for OUD.
reSET-O is an innovative response to the ongoing opioid crisis in America, which is the deadliest it has ever been.1,2 In the Tampa Bay area, the overdose rate is 23 out of every 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 & Central Florida Behavioral Health Network to explore ways to better serve our patients. The reSET-O digital therapeutic pilot project focuses on helping our patients engage in treatment and improve patient outcomes,” said Deanna Obregon, Chief Executive Officer of Behavioral Health.
“We are pleased that the Department of Children and Families approved the use of the reSET-O for persons in need to prevent relapse. This program is made possible through use of SOR (State Opioid Response) funding,” said Linda McKinnon, Chief Executive Officer of Central Florida Behavioral Health Network.
Cove, which serves over 30,000 individuals 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 the rates of substance misuse among Hispanic Americans are similar to those of the overall U.S. population, there is a gap between Hispanics and the rest of the population when it comes to substance use disorder treatment. Some of the disparities in treatment that occur within the Hispanic community can be resolved through increased availability of culturally sensitive treatment programs, including the offering of bilingual or exclusively Spanish speaking activities.4
“Pear is excited to team with Cove at a time when it’s more important than ever to provide people with OUD access to evidence-based treatments,” said Julia Strandberg, Chief Commercial Officer of Pear. “Our PDTs are innovative, FDA-authorized therapeutics designed to be used remotely anytime, anywhere by patients. We believe that Cove and Pear can help expand access to care and benefit patients in recovery.”
PDTs are a new therapeutic class that use software to treat serious disease. Like traditional medicines, PDTs are developed in a Good Manufacturing Practice-compliant environment; tested in randomized controlled trials to demonstrate safety and effectiveness; authorized by the 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 payors and health systems.
reSET-O Important Safety Information
Indications for Use
reSET-O is 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 prescription digital therapeutic.
Important Safety Information:
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.
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 treatment need, and reducing opioid overdose related deaths through the provision of prevention, treatment and recovery activities for opioid use disorder (OUD) (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., 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.
About Cove Behavioral Health
For almost 50 years, Cove Behavioral Health has been here for the Tampa Bay Community, helping those suffering from substance use and mental health disorders. Cove’s mission is to support our community’s overall wellness by providing accessible and compassionate behavioral health care. From mental health to substance use disorders, our trained and skilled clinicians are here to help each person through their journey. Cove serves over 30,000 individuals each year through treatment, prevention, education, and outreach in Hillsborough and surrounding counties.
- Alvarez, J., Jason, L.A., Olson, B.D., Ferrari, J.R., & Davis, M.I. (2007). Substance abuse prevalence and treatment among Latinos and Latinas. Journal of Ethnicity in Substance Abuse, 6(2), 115-141.