Dive Brief:
- A device that mechanically stimulates the colon to treat adults with chronic constipation has been authorized by the Food and Drug Administration.
- Vibrant Gastro secured marketing authorization from the FDA after linking its orally administered drug-free capsule to increased complete spontaneous bowel movements in a pivotal clinical trial.
- Having secured the agency’s authorization, the company plans to make the device, branded Vibrant, available in select states in 2023 before gradually expanding nationally throughout the year.
Chronic constipation is an issue for millions of people despite the availability of over-the-counter and prescription medicines, with estimates of the prevalence in North America ranging from 2% to 27%. Work to improve outcomes has included the development of external vibration devices, such as belts and platforms, that provide mechanical stimulation.
Vibrant’s device builds on that idea. As a vibrating capsule, the device is designed to improve on external devices by stimulating the intestinal wall through local contact and thereby enhancing movement of the stool. To test the hypothesis, researchers enrolled 312 patients with chronic constipation at 90 U.S. sites.
The trial, data from which were reported in May, found 39.26% of patients in the Vibrant arm had one or more complete spontaneous bowel movements per week versus baseline, compared to 22.15% of their counterparts in the control group. The proportion of participants who had two or more additional bowel movements was also higher in the treatment arm, 22.7%, than the control cohort, 11.41%.
No participants reported severe adverse events or treatment-related diarrhea or nausea, giving Vibrant a dataset that persuaded the FDA to authorize the device. Vibrant now is preparing for a 2023 rollout of the device.
Users of the device will place each capsule in a pod. The pod activates the device, after which the patient swallows the capsule with a glass of water and uses a companion app to monitor their treatment.
