metaMe Health Receives FDA Clearance for Regulora®, the First FDA-authorized Treatment Specifically for Abdominal Pain Due to Irritable Bowel Syndrome (IBS)

metaMe Health, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted clearance for Regulora®, the first FDA-authorized treatment of any kind specifically for abdominal pain associated with irritable bowel syndrome (IBS) in adults.

Treatment of abdominal pain associated with IBS is poised for a fundamental shift in clinical practice. The COVID-19 pandemic has prevented patients from engaging in many of the activities of daily living and has led to increases in pain and psychological distress due to IBS-related symptoms (1). This has created a growing unmet medical need for self-administered behavioral therapy options to treat IBS.

Regulora provides behavioral therapy based on Gut-Directed Hypnotherapy (GDH) through a convenient smartphone app that can be used at home. GDH helps patients with their IBS symptoms by promoting healthier control of digestive tract function and delivering therapy designed to influence pain sensation (2). Until now, GDH has been provided only in-person by licensed therapists.