Pear Therapeutics, Inc., the leader in prescription digital therapeutics (PDTs), today announced that it is launching a limited distribution program for its product candidate, Pear-004, for people living with schizophrenia. Based on FDA’s Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, Pear plans to provide patients with access to Pear-004 through collaborations with select healthcare providers and academic centers. Unlike Pear’s FDA-authorized products, reSET®, reSET-O®, and Somryst™, Pear-004 has not received market authorization from FDA.
Similar to past public health emergencies, FDA has exercised enforcement discretion for certain types of products to allow for expanded patient access during the COVID-19 crisis. Pear supports FDA’s COVID-19 Emergency Guidance as a step to expand access to PDTs at a time when patients need remote care because of difficulty in accessing healthcare providers in person.
“The COVID-19 pandemic has disrupted mental health care for people with serious mental illness like schizophrenia, as it has all sectors of society, and impeded their access to essential treatments,” said Jeffrey A. Lieberman, M.D., Lawrence C. Kolb Professor and Chairman, Department of Psychiatry, Columbia University College of Physicians and Surgeons. “In response, mental health providers have readily adopted virtual methods of communication and practiced telepsychiatry. PDTs will usefully augment the scope and quality of services provided. In this context, Pear-004 could play a critical role in demonstrating the value of technology-based mental health care particularly when access to face-to-face clinical interventions is limited.”
Pear also supports FDA providing guidance on quality standards necessary for emergency release of digital health devices that have not achieved market authorization. Pear believes that clear and explicit labeling is critical for patients and physicians to properly and safely utilize non-FDA-cleared digital therapeutics.
Pear demonstrates its commitment to FDA’s labeling and quality standards with its three commercial products, all of which have received marketing authorization, and all of which have clear safety and efficacy claims in their FDA-authorized labels. The release of Pear-004 on a temporary basis via this limited distribution program represents Pear’s commitment to providing a product candidate to patients with heightened need under FDA’s emergency guidance.
“Thanks to FDA’s Emergency Guidance, Pear is pleased to have the opportunity to help people suffering from schizophrenia by providing temporary access to our product candidate, Pear-004, during this time of greater need,” said Corey McCann, M.D., Ph.D., President and CEO of Pear Therapeutics. “We embrace FDA’s guidance to temporarily expand the availability of experimental digital therapeutics to facilitate patient use during a time of heightened stress and to reduce potential exposure to COVID-19.”
Pear-004 is a product candidate being studied as a potential treatment for people with schizophrenia.
Pear-004 is not intended to replace time with a patient’s clinician. A patient should contact his or her clinician before using Pear-004. Pear-004 is not a substitute for a patient’s medications.
Pear-004 has been developed, in part, with direct feedback from patients with schizophrenia and evaluated in two clinical studies (one study with 3 parts) consisting of 167 patients. Data from these studies showed high patient satisfaction and engagement among patients with schizophrenia, and no reports of adverse events related to Pear-004.[1-3]
Pear-004 is a product candidate in development to improve core symptoms and depression in people living with schizophrenia by providing multimodal neurobehavioral interventions in combination with standard of care anti-psychotic medication. Pear-004 provides social skills training, cognitive behavioral therapy (CBT) for psychosis, and illness self-management training. Pear-004 is designed for adults 18 years and older who are currently under the supervision of a clinician.
In developing Pear-004, Pear follows FDA’s Good Manufacturing Practices (GMP) requirements (21 CFR Part 820), which require manufacturers to implement and maintain a quality system so its products and product candidates consistently meet applicable specifications.
Pear-004 has not been evaluated in a pivotal clinical trial. Pear-004 and its clinical data have neither been reviewed nor market authorized by FDA. Therefore, Pear makes no safety or efficacy claims, express or implied, as to Pear-004, and specifically disclaims any such claims unless and until FDA provides market authorization to Pear-004 for its proposed indications for use.
Pear Therapeutics is the leader in prescription digital therapeutics, or PDTs. Pear aims to redefine medicine by discovering, developing, and delivering 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 a pipeline of products and product candidates across therapeutic areas. Pear’s lead product, reSET®, for the treatment of Substance Use Disorder, was the first PDT to receive marketing authorization from 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.
 Campellone, T.R., Smayda, K.E, & Maricich, Y.A. (2019). Agile development of a prescription digital therapeutic for patients with schizophrenia. Presented at the annual American Psychiatric Association in San Francisco, CA.
 Maricich Y, Lipschitz J, Baker J, Luderer H. A Controlled Study Evaluating THRIVE, a Prescription Digital Therapeutic Used as an Adjunct to Atypical Antipsychotic Treatment for Schizophrenia. Poster presented at: 171st Annual Meeting of the American Psychiatric Association; May 5-9, 2018; New York, NY.
 Campellone TR, Smayda KE, Maricich YA. Patient-Centered Iterative Development of a Prescription Digital Therapeutic for Patients with Schizophrenia. Poster presented at: Association for Behavioral and Cognitive Therapies 53rd Annual Convention; November 21-24, 2019; Atlanta, GA.