AppliedVR, a pioneer advancing the next generation of digital medicine, today announced its EaseVRx product received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for treating treatment-resistant fibromyalgia and chronic intractable lower back pain. 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
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.