FDA approves new vibrating pill for chronic constipation

(CNN) — People who struggle with chronic constipation have a new drug-free option to help get things moving again.

It’s a first-of-its-kind capsule about is the size of a regular pill — but instead of releasing medication after it’s swallowed, it vibrates to stimulate the colon.

The capsules, called Vibrant, was cleared by the US Food and Drug Administration in August but just became available for doctors to prescribe this week.

Doctors consider a person to be constipated when they’re having fewer than three bowel movements in a week. Between 10% to 20% of Americans live with persistent constipation that doesn’t have a discernible cause, according to a recent survey. They tend to have hard, dry stools that may cause pain and bloating.

The idea behind the treatment is that a single vibrant pill is taken around bedtime every day. It then travels the same route as food does, through the stomach and small intestine, finally reaching the large intestine about 14 hours later. Then, it goes to work.

The pills stimulate specialized nerve cells in the gut called mechanosensory cells. These help trigger peristalsis, the undulating muscle contractions that help squeeze food through the gut.

“There are little vibrations for three seconds on, three seconds off,” said Cathy Collis, chief commercial officer for Vibrant Gastro, which is based in Israel but has offices in the US.

Before use, each pill is activated in a little pod that turns it on. After it’s swallowed, it is active for about two hours, goes quiet for around six hours and then activates again for another two hours.

Finally, after they’ve done their job, the person’s body poops them out, and they’re flushed away.

The capsules are not a cure. They’re designed to be taken daily, the same way you would take other maintenance treatments.

According to the company, the capsules are made of a medical-grade material also used for the pill cameras that gastroenterologists have used for the past 15 years.

To get FDA clearance, Vibrant had to demonstrate that there were no toxic materials in the pills and that they could withstand, for example, the force of a bite in case someone accidentally bit them.

The company also had to show that the capsules didn’t pose certain risks, such as causing infections, irritating tissues, interfering with other electronic devices, getting stuck or not working at all.

Like contact lenses and syringes, the FDA considers them to be class 2 medical devices, meaning they carry intermediate risk to of harm to the user.

Once the pills make their way into sewage, they are sifted out and taken to a landfill as non-compostable material.

Fewer side effects

In a small clinical trial, 349 people with chronic constipation were divided into two groups: 200 who took the vibrating capsules every day for eight weeks and 149 who swallowed a lookalike pill that didn’t vibrate.

The people who took the Vibrant pills reported being able to go more often and to empty their bowels more completely compared with those who didn’t get the active capsules.

About 40% of the group taking the Vibrant pills reported having at least one additional bowel movement a week, compared with about 23% of the placebo group. They also reported softer stools and less bloating.

The percentage of patients who reported two or more additional bowel movements each week was 23% in the group that took the Vibrant pills and about 12% in the group taking the placebo.

Most people said they couldn’t feel the pills working, but some did.

“A minority could feel it,” said Dr. Eamonn Quigley, chief of gastroenterology at Houston Methodist Hospital. Quigley helped test the capsules, but he doesn’t have any financial stake in the company. “None of them felt it was being uncomfortable. And none of them stopped taking it because of that.”

He says he can’t directly compare the effectiveness of the Vibrant capsules to other kinds of remedies because they weren’t tested head-to-head in the study. But he says the degree of relief with the Vibrant capsules appears to be similar to how prescription drugs for constipation performed in their clinical trials.

People who took the Vibrant capsules reported no serious adverse events, like bowel obstructions. More digestive side effects were reported in the placebo group than in the Vibrant group: 9.4% vs. 6.5%, respectively. Two people who took the Vibrant capsules reported diarrhea, but it wasn’t common.

“One of the important side effects that it does not have is diarrhea, as a lot of the prescription drugs can lead to diarrhea,” Quigley noted.

That’s because most prescription constipation drugs work in the small intestine, where they release more fluid and secretions into digesting food.

Dr. Satish Rao, distinguished chair of gastroenterology at Augusta University’s School of Medicine, says there’s no question that prescription medications for constipation work, but they target a different area than the vibrating pill. “If you just think about it from a mechanistic perspective, they are working a little away from where the problem is, but they are helping the problem,” said Rao, who also helped test the capsules.

By contrast, the Vibrant capsules work in the colon, which is the source of the trouble, he says.

Stimulating the gut without drugs

The vibrating capsules are programmed to work in a specific way, and they’re FDA-authorized only to treat chronic constipation in adults who haven’t gotten help from or who can’t tolerate side effects of over-the-counter or prescription medications.

People who have trouble swallowing or who have paralysis of their stomach, called gastroparesis, should not take Vibrant pills, Collis said. They’re also not a good idea for people who have a history of bowel obstructions.

But Rao thinks that with more study and fine-tuning, experts might be able to reprogram the pills so they would go to work earlier, perhaps in the stomach, potentially to help people with gastroparesis.

He thinks it might also be possible down the road to personalize the programming of the capsule to better address the needs of individual patients.

Vibrant is not currently covered by insurance, Collis says. For those who have health insurance, the company is offering a coupon to cap out-of-pocket costs at $69 per month. They’re not a cure; people need to take them consistently to see relief.

“We are working right now with insurance companies to obtain coverage in commercial plans,” she said. “But until we get that coverage, our goal and commitment is to make sure that this is accessible and affordable to patients.”