Pear Therapeutics is rolling out its new digital therapeutic aimed at treating schizophrenia for limited distribution, after the FDA loosened up its regulations for digital psychiatric disorders devices during the coronavirus crisis.
The new tool, called Pear-004, uses multimodal neurobehavioral interventions combined with antipsychotic medications. Patients with schizophrenia can use the tool for social skills training, cognitive behavioral therapy for psychosis and for illness self-management training. Pear-004 has to be used under a doctor’s supervision. The company is collaborating with select healthcare providers and academic institutions for the initial distribution.
Two weeks ago, the FDA came out with a new guidance that waives several regulatory requirements for devices aimed at treating psychiatric disorders including submission of 510(k) premarket notifications, reports of corrections and removals requirements, registration and listing requirements, and unique device identification (UDI) requirements.
The agency is still requiring that products undergo and demonstrate software verification, validation and hazard analysis; meet FDA's requirements for cybersecurity protections; include labeling instructing patients to contact a physician prior to using the device; and prompt users to acknowledge the physician contact recommendation.
Today Pear-004 is still categorized as a “potential treatment for people with schizophrenia” and has yet to be evaluated in a pivotal clinical trial or have its clinical data reviewed by the FDA. However, the company said the product has been used in two clinical studies, which show high satisfaction and engagement rates among patients.
“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,” Dr. Corey McCann, president and CEO of Pear Therapeutics, said in a statement. “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.”
The FDA wrote in last week's guidance that the relaxed restrictions enabling Pear’s release are only intended to last for the duration of the COVID-19 emergency.
WHY IT MATTERS
Around the world there are over 20 million people with schizophrenia, according to the World Health Organization.
The coronavirus pandemic has created obstacles for getting patients care. Today many doctors are turning to digital tools as a way to get more resources into the hands of patients.
“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 Dr. Jeffrey A. Lieberman, Pear advisor and chair of the Department of Psychiatry, Columbia University College of Physicians and Surgeons, said in a statement. “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.”
THE LARGER TREND
This isn’t the first digital therapeutic to take advantage of the relaxed guidelines. Last week Akili has fast-tracked and released its approval-pending digital therapeutic, Endeavor, for children with ADHD.
While Pear-004 is temporarily taking an alternative route to the traditional 510(k) clearance, Pear Therapeutics is no stranger to the process. In 2017 it landed a de novo for its digital therapeutic reSET, which treats substance abuse disorders. More recently it landed clearance for Somryst, a prescription digital therapeutic for chronic insomnia, which was the first to be evaluated through the FDA's Digital Health Software Precertification Program.