The FDA issued marketing authorization for a novel, drug-free treatment for chronic constipation.
Dubbed Vibrant System, the treatment is indicated for patients with chronic idiopathic constipation who failed to achieve bowel symptom relief after at least 1 month of taking recommended doses of laxatives.
The orally administered first-of-its-kind product involves a single-use capsule and pod that activates the vibrating capsule. Patients are directed to ingest the capsule with a glass of water and can monitor the treatment using a mobile app.
According to developer Vibrant Gastro, the “treatment is thought to enhance colonic motility by augmenting the biological clock via mechanical stimulation of the colon.”
Safety and efficacy data supporting the authorization came from 312 patients with chronic idiopathic constipation who participated in a phase III trial.
Nearly twice as many patients treated with the vibrating capsule had at least one additional complete spontaneous bowel movement each week (compared with baseline) versus a placebo group (40.5% vs 22.9%, respectively, P=0.0011). Additionally, twice as many patients on the Vibrant System had at least two additional complete bowel movements each week compared with the controls (23.4% vs 11.8%).
Adverse events with the vibrating capsule were less frequent compared with the placebo group (6.5% vs 9.4%), and no serious adverse events were reported. Two patients in the study arm reported diarrhea.
“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,” said principal investigator Satish Rao, MD, PhD, of the Medical College of Georgia, in a press release from the company. “We believe the Vibrant System is a meaningful step towards achieving that goal.”
Chronic constipation is a common gastrointestinal disorder affecting approximately 16% of individuals in the U.S. It also comes with significant treatment costs. About 70% to 90% of patients experience symptoms of straining, bloating, and hard stools, which reduce individuals’ quality of life.
Vibrant is expected to be available early next year in select states, with gradual expansion nationally after that.