Life Sciences and Healthcare Industry: FDA Authorizes Marketing of Virtual Reality System for Chronic Pain Reduction
On November 16, 2021, the US Food and Drug Administration (“FDA”) authorized the marketing of EaseVRx, a prescription-use immersive virtual reality (“VR”) system that uses cognitive behavioral therapy (“CBT”) and other behavioral methods to help with reducing pain in patients 18 years of age and older with diagnosed chronic lower back pain. It has been stated that authorization provides a pain-reduction therapy alternative that does not involve opioid pain drugs when used in conjunction with other treatment options for persistent lower back pain.
While it was explicated that chronic lower back pain, which is defined as moderate to severe pain in the lower back that lasts more than three months, is one of the most frequent chronic pain diseases in the US, chronic pain can impair mobility or daily activities and has been linked to anxiety and depression, poor perceived health or a lower quality of life, and opioid dependence, the FDA also noted that current treatment plans for chronic lower back pain often include, among other things, prescription and over-the-counter pain medications, exercise, steroid injections, surgery, and transcutaneous electrical nerve stimulation. With this respect, it was explained that CBT may be used to reduce the burden of chronic pain and promote function by using an emotional, cognitive, and behavioral approach to modify negative ideas held by patients about the relationship between their pain and movement.
The FDA further explained that EaseVRx reduces pain and pain interference by utilizing CBT principles and other behavioral treatment strategies. The prescription device, which is aimed for at-home usage, comprises a VR headset and a controller, as well as a “Breathing Amplifier” linked to the headset, which directs a patient’s breath into the headset’s microphone for use in deep breathing exercises. Deep relaxation, attention-shifting, interoceptive awareness–the ability to identify, access, understand, and respond appropriately to patterns of internal signals and perspective-taking, distraction, immersive enjoyment, self-compassion, healthy movement, acceptance, visualization, knowledge of pain, and rehabilitation are all used in the device’s VR program to address the physiological symptoms of pain and aid in pain relief through a skills-based treatment program.
The FDA indicated that they assessed the safety and efficacy of EaseVRx in a randomized, double-blind clinical study of 179 individuals with persistent lower back pain who were randomly allocated to one of two eight-week VR programs. As per the FDA’s study, over the treatment of eight weeks, participants’ pain severity decreased by 1.31 points on average. Participants also reported a reduction in pain interference for all evaluated outcomes ranging from .95 to 1.27 points lower than their respective scores at the commencement of therapy. During the study, no major negative effects were observed or reported.
EaseVRx has been designated as a Breakthrough Device and was assessed using the De Novo premarket review method. The Breakthrough Devices Program is defined by the FDA as a voluntary program for certain medical devices and device-led combination products that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
A device must be intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition and meet one of the following criteria to qualify for the Breakthrough Device Program: the device must represent a breakthrough technology; there must be no approved or cleared alternatives; the device must offer significant advantages over existing approved or cleared alternatives, or the availability of the device is in the best interest of patients. Regarding the Breakthrough Devices Program, the FDA also specifies that the goal is to provide patients and health care providers with timely access to these medical devices by accelerating their development, assessment, and review while maintaining the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization.
The De Novo premarket review method is a regulatory procedure for low-to-moderate-risk new devices and with this authorization, the FDA implements unique safeguards for devices of this sort, including labeling and performance testing requirements.
Simge Kılıç, Esra Temur
