FDA Clears Digital Therapeutic for Abdominal Pain from IBS
Irritable bowel syndrome, one of the most commonly diagnosed GI conditions, is estimated to affect roughly 10% of adults in the U.S. The condition, characterized by abdominal pain, bloating, and diarrhea or constipation, can have different triggers for each patient. For example, certain foods, stress, and other factors can cause symptoms to flare up.
MetaMe Health, a startup building an app-based treatment to help alleviate some of these symptoms, recently received FDA clearance for its digital therapeutic, called Regulora. It’s built around research by University of North Carolina psychologist Olafur Palsson, who studies the use of psychological treatments for IBS and other GI disorders. Although the exact cause of IBS is unknown, one idea is that the connection between the brain and the gut can contribute to symptoms.
The app uses self-directed hypnotherapy, with the idea of bringing people into a state of relaxation, and creating a sense of ease around their condition and symptoms. It’s intended to be used in conjunction with other treatments, which can include dietary changes or medications.
The treatment consists of seven 30-minute sessions of behavioral therapy over a period of 12 weeks. The FDA cleared it based on data from a randomized, controlled trial of 362 people, where half used Regulora for 12 weeks and the control group used a digital program for muscle relaxation therapy.
Both groups saw an improvement in abdominal pain in the four weeks after the treatment period, but the difference between the treatment group and control group was not statistically significant. However, during the final four weeks of treatment, 30.9% of subjects who used Regulora saw an improvement in abdominal pain intensity, compared to 21.5% of subjects in the control group.
A few other companies are also working on digital treatments for IBS. For instance, Parallel, which was cleared by the FDA a year ago, also is focused on using cognitive behavioral therapy for IBS. Meanwhile, startup Oshi Health recently raised $23 million for its virtual care platform, which connects patients to gastroenterologists, dieticians, mental health providers and health coaches to help them manage GI conditions.
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