Jeffrey Roberts Posted December 7, 2021 Report Share Posted December 7, 2021 metaMe Health Receives FDA Clearance for Regulora®, the First FDA-authorized Treatment Specifically for Abdominal Pain Due to Irritable Bowel Syndrome (IBS) Abdominal pain is the primary symptom of all IBS subtypes (IBS-C, IBS-D, and IBS-M), and is the number one reason patients seek treatment for their IBS. Regulora® is a prescription Digital Therapeutic (PDT) that is self-administered through an Apple or Android smartphone. Chicago, IL - November 30, 2021 – 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. 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. Until now, GDH has been provided only in-person by licensed therapists. “The FDA’s clearance of Regulora, our first PDT, is a major achievement for the company,” said Tim Rudolphi, CEO of metaMe Health. “We are eager to expand access of this proven therapy to patients with all three subtypes of IBS.” Regulora provides a valuable treatment option for IBS patients and their physicians. “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.” said Dr. Olafur Palsson, Professor of Medicine in the Division of Gastroenterology and Hepatology at the University of North Carolina. Irritable Bowel Syndrome is a chronic condition of the lower gastrointestinal tract that affects 10-15% of adults in the United States. IBS accounts for nearly 3.5 million physician visits in the U.S. annually and is one of the most common diagnosis made by gastroenterologists. “IBS is a widespread and debilitating condition that arises partially from miscommunication between the brain and the gut. Stress and other external factors can contribute to normal gut signals being amplified and misinterpreted by the brain as abdominal pain. Treatments like Regulora aim to normalize brain-gut communication” explained Dr. Neil Sengupta, Assistant Professor of Gastroenterology at the University of Chicago Pritzker School of Medicine. About Regulora Regulora is a digital therapeutic mobile app that is downloaded onto an Apple or Android mobile device. Regulora provides for seven 30-minute sessions of remote behavioral therapy based on Gut-Directed Hypnotherapy (GDH) that are administered over a period of 12 weeks. Prior to Regulora, GDH therapy would be provided only via a trained clinician in a medical clinic. With Regulora, video GDH treatment sessions are presented on your mobile device. GDH provided in the clinic by trained therapists has been shown in numerous studies to help patients improve their IBS symptoms, including abdominal pain, constipation, diarrhea, and bloating. According to a 2020 systematic review of the scientific research, among the behavioral treatments for IBS, GDH has strong evidence of effectiveness and produces long-lasting beneficial effects. Clinical Evidence Supporting Regulora Regulora was evaluated in a multi-site, randomized, controlled, and blinded clinical trial of 362 evaluable subjects. Two of three analyses of the primary endpoint of abdominal pain achieved clinically significant separation from the control arm. Additionally, 68% of subjects assigned to Regulora reported overall satisfaction with the treatment and 87% would recommend Regulora to someone else with IBS. No serious adverse events were associated with Regulora. About 1% of study participants experienced non-serious adverse events including abdominal pain, constipation, fatigue, or headache. 87% of subjects assigned to Regulora were adherent to therapy. Regulora Indications for Use Regulora is a prescription-only digital therapeutic device intended to provide behavioral therapy through gut-directed hypnotherapy for adults 22 years of age and older who have been diagnosed with Irritable Bowel Syndrome (IBS). Regulora is indicated as a 3-month treatment for patients with abdominal pain due to IBS and is intended to be used together with other IBS treatments. About IBS Irritable Bowel Syndrome is a chronic condition that affects 10-15% of adults in the United States. The central symptom is abdominal pain, which is accompanied by diarrhea (IBS-D), constipation (IBS-C), or mixed periods (IBS-M). IBS has a severe impact on quality of life; IBS sufferers say they would give 25% of their remaining life (an average of 15 years) to live symptom-free, according to a survey of nearly 2000 patients. Symptoms are mediated by a dysregulation of the sensory and motility signaling between the brain and the gut and exacerbated by cognitive, behavioral, affective, and physiologic factors. The annual cost of IBS treatment in the United States has been estimated to be between $1.7 billion and $10 billion in direct costs, with total indirect costs of $20 billion. References  Kamp et al. J Clin Gastroenterology. 2021; PMID:33780216.  Palsson OS. Am J Clin Hypn. 2015; PMID: 26264539.  International Foundation for Gastrointestinal Disorders (IFFGD) Facts About IBS (https://aboutibs.org/what-is-ibs/facts-about-ibs/statistics/).  Black et al. Gut. 2020; PMID: 32276950.  Gastrointestinal Society IBS Global Impact Report 2018 (https://badgut.org/wp-content/uploads/IBS-Global-Impact-Report.pdf).  Hulisz, D., J Managed Care Pharm, 2004. PMID 15298528. About metaMe Health, Inc. metaMe Health is committed to developing FDA-cleared Prescription Digital Therapeutics (PDT) for the treatment of gastrointestinal conditions. Prescription Digital Therapeutics are software applications that deliver evidence-based therapeutic interventions to patients to prevent or treat a medical disorder or disease. They are used independently or in concert with medications or other therapies to optimize patient care and health outcomes. PDTs are developed under rigorous conditions complete with clinical trials, FDA clearance, and availability only through a physician’s prescription. 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