What to Know About Regulora, the FDA-Cleared Digital Therapeutic for IBS

People with irritable bowel syndrome (IBS) often experience a lot of problems with their bowel movements. Constipation, diarrhea, and bloating are just a few IBS symptoms. These symptoms are often accompanied by abdominal pain that tends to get better after going to the bathroom.

IBS isn't a small problem. It’s estimated that between 10% to 15% of people in the U.S. have the condition — but only about 5% of people have been officially diagnosed with it. So there’s a good chance that you or someone you know has IBS.

IBS has many treatment options to help address abdominal pain, diarrhea, and other symptoms. Generally, medications and lifestyle or dietary changes are suggested treatments. But the American College of Gastroenterology also recommends using gut-directed psychotherapies to help improve IBS symptoms. Typically, these types of therapy are conducted in person by a therapist.

However, getting set up with this type of therapy can be challenging. Finding a therapist who can provide this type of treatment may pose a barrier for many people. But recent advances in digital health have helped to bridge this gap and make these treatments more accessible.

Here, we’ll discuss Regulora, a new option for treating IBS pain.

What is Regulora? 

Regulora is a prescription digital therapeutic that was FDA-cleared in November 2021 to treat abdominal pain due to IBS in adults ages 22 and older. A digital therapeutic is when a type of technology can help manage a medical condition. Regulora is the first treatment of any kind (including medications) that’s labeled specifically for IBS pain.

Regulora is available on Apple and Android-based devices through an app that you can download to a smartphone or tablet. Using Regulora provides you with a type of therapy that can help lower the amount of pain you experience with IBS.

How does Regulora help treat abdominal pain from IBS?

Regulora works by using gut-directed hypnotherapy (GDH). GDH is a type of therapy that helps improve the connection between your gut and your brain. While experts don’t know what causes IBS specifically, one possible explanation is a problem with the gut-brain axis. This is the term for how your thoughts or feelings affect your gut health — and vice versa.

GDH has been found to be beneficial for many people with IBS and other gastrointestinal problems (conditions that affect the stomach or intestines). This type of therapy helps you learn to redirect the pain IBS is causing. This helps your brain to perceive less pain.

Usually, GDH is done in person with a therapist. Regulora brings this form of therapy directly to your smartphone or tablet. It may be an option if you’re having trouble finding a therapist to meet with or if a GDH therapist is too far from where you live.

Does Regulora require a prescription?

Yes, a healthcare provider’s prescription is required to use the app. You could download the Regulora app to your smartphone or tablet. But, you won’t be able to activate or use it without a prescription. After your healthcare provider has prescribed Regulora for you, they’ll give you a unique access code to enter on your mobile device when setting up the app.

How do you use Regulora?

With Regulora, you’ll access GDH through a mobile app. Over a 3-month period, you’ll receive seven GDH sessions. Each session lasts about 30 minutes. This is similar to what you may receive with a therapist delivering hypnotherapy in person.

For the best experience, place your smartphone or tablet into “Do Not Disturb” mode before starting a treatment session. This will help limit distractions. If your session was interrupted, you’ll have the option to begin it again. You can begin a treatment session again up to 3 times if needed.

Regulora also gives you access to 15-minute practice sessions in between each of the seven treatment sessions. The maker of Regulora, metaMe Health, recommends completing three practice sessions in between treatment sessions.

Can you use Regulora with and without medications?

In Regulora’s clinical trial, people who were using Regulora were allowed to keep taking their IBS medications. However, it did not note which medications were used. Study participants were asked not to change, start, or stop IBS medications during the study unless directed by a healthcare provider.

Experts state that current research suggests GDH is effective when used together with medication. They also note that GDH hasn’t been compared to medication in studies yet. So we can’t say if Regulora or any form of GDH can be used in place of medications. That’s a decision best made with your healthcare provider’s guidance.

How effective is Regulora?

In its clinical trial, Regulora was compared to software that provided muscle relaxation techniques. Researchers found that about 30% of those using Regulora experienced at least a 30% improvement in abdominal pain. About 19% of those using the muscle relaxation software had the same amount of pain relief. Regulora didn’t significantly lower the number of days of having pain with IBS, the number of bowel movements, or the type of stool.

It’s important to note that the study looked at those between 18 and 70 years of age. Most of the people in the study were women. People who had mental health conditions, like severe depression, weren’t included in the study. When groups of people are excluded from research studies, it makes it hard to say if they’d experience the same results.

Does Regulora have side effects?

There were no major side effects with using Regulora in its clinical trial. A very small number of people reported:

• Headache

• Tiredness

• Abdominal pain

• Constipation

If you experience any discomfort or if your IBS symptoms worsen after starting Regulora, contact your healthcare provider.

How much does Regulora cost?

The manufacturers of Regulora will attempt to bill your insurance first when getting you set up. While insurance plans are starting to cover digital therapeutics, not all plans cover these types of treatments yet. If your insurance doesn’t cover Regulora, the manufacturer will apply a discount to help you save. Regulora will cost no more than $75 in this case. This is also the cost if you don’t have insurance.

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Written by:

Timothy Aungst, PharmD

Timothy Aungst, PharmD, has worked in pharmacy practice for the past decade with different roles and responsibilities. He has served as an associate professor of pharmacy practice for almost a decade, a clinical pharmacist in outpatient cardiology management, and now in home healthcare.

Edited by:

Christina Aungst, PharmD

Christina Aungst, PharmD, is a pharmacy editor for GoodRx. She began writing for GoodRx Health in 2019, transitioning from freelance writer to editor in 2021.

Reviewed by:

Joshua Murdock, PharmD, BCBBS

Joshua Murdock, PharmD, BCBBS, is a licensed pharmacist in Arizona, Colorado, and Rhode Island. He has worked in the pharmacy industry for more than 10 years and currently serves as a pharmacy editor for GoodRx.

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