Provided by Vibrant
Doctors may now prescribe a new treatment in the form of vibrating tablets to treat chronic constipation.
Vibrant, the first treatment of its kind, manufactured by medical device manufacturer Vibrant Gastro, received U.S. Food and Drug Administration (FDA) approval in August 2022. One company says doctors can now prescribe it this week. news release.
Chronic constipation is thought to affect approximately 16% of Americans. Unlike other gastrointestinal diseases such as inflammatory bowel disease (IBD), chronic idiopathic constipation, also known as functional constipation, is a condition characterized by difficulty in defecating, without an underlying physiological reason or evidence of disease. It is characterized by being infrequent or incomplete.
Treatment options for chronic constipation usually include dietary changes such as eating more fiber and taking osmotic or stimulant laxatives. But Vibrant is different. Instead, drug-free capsules provide mechanical stimulation to the large intestine from within.
“This pill stimulates special nerve cells called mechanosensory cells in the intestines.” Ben FeldmanChief Marketing Officer of Vibrant Gastro said: health. “These help cause peristalsis, wave-like muscle contractions that help squeeze food out of your intestines.”
While the premise of a vibrating pill to treat constipation may seem futuristic, this FDA-approved treatment has been proven to provide significant relief for people suffering from chronic constipation. I am.
Vibrant works by increasing colon motility by adding mechanical aid to the body’s biological clock.according to Rudolph Bedford, MarylandThe pill’s vibrations may help “wake up” the body’s digestive system, said Dr. John, a gastroenterologist at Providence St. John’s Health Center who was not involved in the treatment.
The tablets are intended to be taken orally before bedtime, 5 days a week (recommended frequency is 3 days on, 1 day off, 2 days on, 1 day off). Capsules must be activated before they can be used with the included pod. Activation takes a few seconds.
Once activated, the capsule is designed to be swallowed immediately with a glass of water. The capsule is activated when swallowed and remains in the body for 2 hours. Then it goes off for 6 hours and then he restarts for another 2 hours.
“The pre-programmed timing of mechanical stimulation is thought to take advantage of the body’s internal clock to improve colonic motility,” Feldman said.
In activation mode, the capsule vibrates almost continuously inside the body. “There is a small vibration for 3 seconds on and 3 seconds off.” Kathy Collissaid Vibrant Gastro’s chief commercial officer in a company news release.
Capsules can be tracked inside the body, and once they pass through the body’s gastrointestinal system, they are excreted through defecation.
To receive FDA approval, Vibrant had to be proven safe and effective in clinical trials.
In a small phase 3 study of 312 patients with chronic idiopathic constipation, researchers found that about 40% of patients who took the vibrating tablet experienced a reduction in their symptoms compared to 23% of patients in the control group. It was discovered that the blunt had caused one additional bowel movement. About 23% of people in the Vibrant group had two more bowel movements per week, compared to only about 12% of people in the control group.
Although Vibrant has not been tested in head-to-head trials and cannot be directly compared to other drugs on the market, the capsules appear to be slightly better tolerated than the placebo used in clinical trials. did. Compared to people who took a placebo pill, people who took Vibrant reported less abdominal pain, bloating, and overall gastrointestinal distress. Although less common, the incidence of nausea, vomiting, and diarrhea was slightly higher with Vibrant than with the placebo tablets.
Also, some patients were able to feel the vibrations of the Vibrant, but it was not disruptive enough to force them to stop treatment.
“A few people may feel it.” Eamon Quigley, MDChief of Gastroenterology at Houston Methodist Hospital said in a company news release. “No one found it uncomfortable. And no one stopped taking it because of it.”
Because Vibrant is a drug-free treatment option, it is classified as a Class 2 medical device by the FDA. This means that the capsules pose a moderate risk and require special controls to ensure safe use. (Other common Class 2 medical devices include contact lenses and pregnancy test kits.)
The capsules are made of medical-grade materials, which are also used in pill cameras used by gastroenterologists in certain circumstances, Feldman explained.
“To obtain FDA approval, Vibrant had to prove that the tablets contained no toxic substances and could withstand the force of chewing if, for example, someone accidentally chewed the tablet. ” Feldman said. The company also needed to prove that the capsules would not cause side effects such as infections or inflammation of body tissues, interfere with electronic devices, get stuck, or be completely ineffective.
Vibrant has been approved by the FDA for use in adults with chronic constipation who do not receive adequate relief from laxatives after one month of use.
However, while the pill has had some success in treating constipation, the treatment is not a cure. “If you had chronic constipation before you started taking it, you may continue to be constipated after taking it,” Dr. Bedford says. “But it doesn’t make things worse or make your intestines lazy.”
Although it is up to patients and their health care providers to decide whether Vibrant is an appropriate course of treatment, the pill may be contraindicated for some patients, including:
- People with a history of complex or obstructive diverticular disease.
- People with a history of or suspected intestinal obstruction.
- Persons with current clinical evidence of significant gastroparesis.
- Persons with a history of severe gastrointestinal disorders (inflammatory bowel disease, gastrointestinal malignancy, untreated/active celiac disease, lacerated anal fistula).
- People with a history of Zenker diverticulum, dysphagia, esophageal stricture, eosinophilic esophagitis, or achalasia.
- People who are pregnant or breastfeeding.
Vibrant is currently more expensive than other over-the-counter options at about $89 per month, but the company is working to make it more affordable. “We are currently working with insurance companies to obtain coverage under commercial plans,” Feldman said. “But until that insurance is covered, our goal and commitment is to make sure this is accessible and affordable for our patients.”
If you’re interested in trying Vibrant, talk to your gastroenterologist to see if you qualify. From there, you will need to contact specialty pharmacy Carepoint for treatment.