EASEVRx Receives FDA Breakthrough Device Designation for Treating Treatment-Resistant Fibromyalgia and Chronic Intractable Lower Back Pain

October 21, 2020

EaseVRx product has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for treating treatment-resistant fibromyalgia and chronic intractable lower back pain. The news was announced today by AppliedVR

EaseVRx is now one of the first virtual reality (VR) digital therapeutics to get breakthrough designation to treat conditions related to chronic pain.

The FDA Breakthrough Device Program helps patients receive more timely access to breakthrough technologies that could provide a more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.

AppliedVR achieved this milestone after successfully completing the first randomized controlled trial (RCT), evaluating VR-based therapy for self-management of chronic pain at home. The RCT, which was published in JMIR-FR, found that a self-administered, skills-based VR treatment program for treating chronic pain was feasible, scalable and was effective at improving on multiple chronic pain outcomes – each of which met or exceeded the 30-percent threshold to be clinically meaningful. On average, participants noted:

• Pain intensity reduced 30 percent;
• Pain-related activity interference reduced 37 percent;
• Pain-related mood interference reduced 50 percent;
• Pain-related sleep interference reduced 40 percent; and
• Pain-related stress interference reduced 49 percent.

“AppliedVR is the most evidence-backed VR platform on the market, and today’s FDA designation demonstrates that health experts across the spectrum recognize the therapeutic potential of VR as a viable treatment for pain,” said Matthew Stoudt, CEO and co-founder of AppliedVR. “Now, with the COVID-19 pandemic severely disrupting Americans’ ability to get in-person care safely, we’re looking forward to getting EaseVRx into the hands of people suffering from pain. Providers believe in it, patients want it, and payers are coming around to it.”

AppliedVR’s EaseVRx program helps patients learn self-management skills grounded in evidence-based cognitive behavioral therapy (CBT) principles and other behavioral methods. The program was designed by AppliedVR, in partnership with the top pain experts and researchers, to improve self-regulation of cognitive, emotional and physiological responses to stress and pain. AppliedVR has already been shown to be an effective treatment for acute pain in hospital settings.

“Virtual reality is a promising skills-based behavioral medicine that has been shown to have high patient engagement and satisfaction,” said Dr. Beth Darnall¹, AppliedVR’s chief science advisor. “However, chronic pain patients to date have had very limited access to it, so we’re excited to continue working with the FDA to develop our platform and get it into the market faster.”

Lower back pain is one of the most common chronic conditions that people face worldwide and represents one of the top reasons why people miss work. Additionally, it’s an extremely costly problem for insurers, especially as they look to cut costs related to back surgery. Recent research indicated that, when combined with neck pain, lower back pain costs nearly $77 billion to private insurance, $45 billion to public insurance, and $12 billion in out-of-pocket costs for patients.

Chronic pain more broadly also is a difficult and costly problem that has contributed to many other major health problems in the U.S., including the opioid epidemic. A previous Johns Hopkins study in the Journal of Pain found that chronic pain can cumulatively cost as high as $635 billion a year — more than the annual costs of cancer, heart disease and diabetes — and lower back pain has been one of the most common reasons for prescribing opioids. Cognitive-behavioral therapies like VR are now seen by many providers as an effective alternative or complement to pharmacological interventions that can support their larger treatment tool belts.

“Since 1980, the American Chronic Pain Association has advocated a multidisciplinary approach to pain management—using a combination of medical and behavioral techniques to address pain,” said Penny Cowan, founder and CEO of the American Chronic Pain Association. “Virtual reality has the potential to be an important resource in this approach, helping people with pain to think differently about their conditions and learn strategies to reduce suffering and improve quality of life.”

AppliedVR is currently engaged in many other trials, including feasibility studies with multiple well-known payers and with the University of California at San Francisco (UCSF) to study how digital therapeutic platforms, including virtual and augmented reality, can be used to improve care access for underserved populations. AppliedVR also is advancing two clinical trials with Geisinger and Cleveland Clinic to study VR as an opioid-sparing tool for acute and chronic pain – specifically the company’s RelieVRx and EaseVRx platforms. The National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), recently awarded $2.9 million grants to fund the trials.

¹ Beth Darnall, PhD also is associate professor at Stanford University School of Medicine and is Director of the Stanford Pain Relief Innovations Lab. She leads NIH and PCORI-funded large clinical trials involving behavioral treatments for acute and chronic pain.