FDA Granted Clearance for Regulora®

Dec 10, 2021

metaMe Health, Inc. 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 behavioural 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.

Regulora provides a valuable treatment option for IBS patients and their physicians. Olafur Palsson, Professor of Medicine in Gastroenterology and Hepatology at the University of North Carolina, commented “Decades of studies show that GDH administered in person by therapists is effective in treating IBS symptoms. However, few therapists are trained in this highly specialized technique, so this option has not been available to most patients. Regulora now makes this treatment accessible to any adult with IBS through their regular doctor or GI specialist, and also makes it far more convenient because no therapist visits are needed.

Read the full article online.

Read more news from the Bowel Interest Group.


[1] Kamp et al. J Clin Gastroenterology. 2021; PMID:33780216.

[2] Palsson OS. Am J Clin Hypn. 2015; PMID: 26264539.