A vibrating pill for constipation heads to the FDA after completing phase 3 study

A small, vibrating pill designed to help people with chronic constipation cleared a clinical study and is headed to the FDA for final review.

Vibrant Gastro is putting forward its approach as a drug-free alternative for infrequent or difficult bowel movements.

Swallowed along with a glass of water, the disposable pill—about the size of an everyday multivitamin—aims to do more than simply shake up any possible blockages. The device is designed to also help reset the connection between the gut and the brain’s circadian rhythm.

As it travels through the digestive system, its vibrations help stimulate the colon’s involuntary contractions, with the ultimate goal of resyncing them with the body’s biological clock to improve regular bowel movements after one to eight weeks of use.

Among 312 participants, 39% reported at least one additional complete bowel movement per week, compared to 22% of those given a placebo pill. Over 22% logged two or more, versus 11% in the control group.

The study also recorded no severe side effects, including treatment-related diarrhea or nausea, according to the company. At the same time, the data also showed improvements in stool consistency and reported quality of life.

“The goal of Vibrant is to address a significant unmet treatment problem in chronic constipation, which has made life very challenging for those who suffer from it,” said Satish Rao, M.D., Ph.D., a professor of medicine at Augusta University, who was one of the primary investigators of a phase 3 study presented at the annual Digestive Disease Week conference.

Israel-based Vibrant estimates that as many as 35 million people in the U.S. suffer from chronic constipation. The company raised $7.5 million in a March 2021 series E round led by Unorthodox Ventures.

Posted on:

https://www.fiercebiotech.com/medtech/vibrating-pill-constipation-heads-fda-after-completing-phase-3-study/

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