The orally-administered, drug-free capsule, Vibrant®, has received marketing authorization by the Food and Drug Administration (FDA) for the treatment of adults with chronic idiopathic constipation who have not experienced relief of their bowel symptoms by using laxative therapies at the recommended dosage for at least 1 month.
The disposable, vibrating capsule enhances colonic motility by resynchronizing the biological clock through mechanical stimulation of the colon. The capsule is directed by a pod, which activates and sends operating instructions to the capsule. Once ingested with a glass of water, the capsule travels through the digestive system with vibrations to stimulate the colon. Patients can monitor the treatment using a companion app.
The marketing authorization was supported by data from a pivotal clinical trial (ClinicalTrials.gov Identifier: NCT03879239) that compared the efficacy and safety of Vibrant to placebo in 312 patients with chronic idiopathic constipation who had not experienced relief of their symptoms from osmotic and stimulant laxatives.
Findings showed that the trial met the primary endpoints with 40.51% of patients treated with Vibrant achieving at least 1 additional complete spontaneous bowel movement (CSBM) per week compared with 22.92% in the control arm (treatment difference of 17.6%; chi-square P =.0011). Moreover, 23.42% of patients treated with Vibrant achieved at least 2 CSBM per week compared with 11.81% in the control arm (treatment difference of 10%). There were no serious adverse events reported with Vibrant.
“The development of Vibrant highlights the kind of scientific advancement we need to address so many ailments today,” said gastroenterologist Satish Rao, MD, PhD, a professor of medicine at the Medical College of Georgia, and a principal investigator in the phase 3 study. “The goal of Vibrant is to address a real problem in chronic constipation, which has made life very challenging for those who suffer from it. We believe the Vibrant System is a meaningful step towards achieving that goal.”
Vibrant is expected to be available in early 2023 in select states with gradual national expansion throughout the year.
FDA grants marketing authorization for Vibrant a new drug-free treatment for adults with chronic constipation. News release. Vibrant Gastro Inc. August 30, 2022. Accessed August 31, 2022. https://www.einnews.com/pr_news/588483585/fda-grants-marketing-authorization-for-vibrant-a-new-drug-free-treatment-for-adults-with-chronic-constipation