Vibrant Gastro’s Drug-Free Capsule Vibrant Gets FDA Marketing Authorization

Vibrant Gastro’s orally administered drug-free capsule Vibrant has received marketing authorization from the FDA for the treatment of adult patients with chronic idiopathic constipation who have not experienced relief of their bowel symptoms by using laxative therapies at the recommended dosage for at least one month.

The device, which the FDA describes as “first-of-a-kind,” is a single-use vibrating capsule that includes a pod to control the capsule’s activation.

The drug-free device enhances colonic motility by augmenting the biological clock via mechanical stimulation, the company said.

The marketing authorization was based on clinical trial results demonstrating that Vibrant led to 40.51 percent of participants achieving at least one additional complete spontaneous bowel movement per week compared to baseline. The capsule is expected to be made available in early 2023 in certain states, with gradual national expansion throughout the year.