Fresh off reporting promising results from a phase 3 study of its constipation relief device, Vibrant Gastro is keeping things moving.
The company’s eponymous vibrating capsule snagged FDA clearance, Vibrant announced this week. The marketing authorization comes just about three months after the medtech maker unveiled its pivotal trial results, which it said at the time had already been submitted to the FDA for review.
The Vibrant pill is now approved for adults with chronic idiopathic constipation who haven’t seen symptom relief after using standard laxatives for at least a month. Chronic constipation affects about 16% of U.S. adults, and as many as 90% of them experience uncomfortable symptoms for many years, according to Vibrant.
With the FDA clearance in hand, the company said it will begin a limited rollout of the Vibrant pill in select states early next year before gradually expanding across the entire country.
To use the capsule, patients first activate it in Vibrant’s accompanying pod, then swallow it with a glass of water. As the pill makes its way through the bowels, it emits low-level vibrations to stimulate the enteric nervous system, which is embedded within the gastrointestinal system and governs its movements.
Vibrant’s capsule aims to resynchronize the biological clock, since disturbances to the body’s natural rhythm have been linked to constipation and other conditions. The pill’s vibrations offer mechanical stimulation to the colon, resetting the biological clock via the nervous system and restoring the natural rhythm of bowel movements.
“Our vision is to accelerate the transition to drug-free treatments that enable millions of constipation patients to live more enjoyable lives by inventing solutions that synchronize and activate the body’s natural gut-brain connection,” CEO Lior Ben Tsur said in the press release covering the capsule’s regulatory nod.
Vibrant also offers a connected app that users can download onto mobile devices and use as an e-diary to track their progress with the vibrating capsule treatments.
The results of Vibrant’s phase 3 study—which were first presented at the 2022 Digestive Disease Week conference in May—showed that the capsule met the trial’s two endpoints covering safety and efficacy based on constipation relief.
In addition, secondary goals also showed key results. After taking two Vibrant pills a week for six weeks, nearly 40% of patients experienced at least one additional complete spontaneous bowel movement per week than they had at the start of the study, compared to just 22% of participants in the study’s placebo group. Those in the experimental group also reported more significant improvements in factors like stool quality, straining and quality of life compared to those on the placebo.