A new vibrating capsule by Vibrant is paving the way for a chemical-free, side-effect-free treatment of chronic constipation.
A widespread, debilitating condition
Chronic constipation, marked by infrequent bowel movements (typically less than 3 per week) and/or difficult passage of stools, affects as many as 48 million Americans. Affecting patients with Chronic Idiopathic Constipation (CIC), with Irritable Bowel Syndrome with Constipation (IBS-C), and Opioid induced constipation (OIC), the condition includes symptoms such as hard stool, straining, bloating, and abdominal discomfort.
Both OTC and prescription drugs provide sub-optimal treatment, and mainly replace the discomfort of constipation with the slightly lesser discomfort of sudden, unpredictable evacuations and side effects. These commonly include dependency, cramping, and diarrhea for osmotic laxatives; dehydration, loss of electrolytes, bloating, and cramping for stimulant laxatives; and nausea and diarrhea for the prescription meds.
Patients are prone to abuse the use of laxatives, become refractory, and – understandably – desperately seek for alternative treatments.
Furthermore, while the annual US market for OTC laxatives is estimated at $800M, there is limited data to support their long-term use. The average wholesale price for prescription meds is significantly higher than that of bulk, stimulant, or osmotic laxatives.
Vibrant’s unique new treatment approach is based on an orally-administered capsule that stimulates bowel movement by mechanically inducing vibrations in the large intestine, resulting in effective, comfortable constipation relief. Rather than disrupting the body’s equilibrium the way drugs do, the capsule simply stimulates the body’s natural evacuation mechanism.
“This new approach signals major improvement to the quality of life of patients. The Vibrant capsule is free of chemicals, free of side-effects, and can be predictably timed, providing the same advance notice on evacuations as would a healthy colon. Rather than being bound to the emergencies of sudden evacuations, patients can now go about their day normally.”
Promising clinical results
Based on three clinical trials, Vibrant has demonstrated clinical benefits with moderate to severe constipated patients. The latest results for the capsule show an excellent safety profile, no side effects, and superior dose–response relationship – with 5 caps per week, providing improved Complete Spontaneous Bowel Movement (CSBM) frequency as compared to 2 caps per week. Additionally, symptoms such as Bristol stool rating (stool consistency), straining, and bloating improved.
“Like a drug, but not a drug”
Patients using Vibrant’s chemical-free capsule report immediate relief of their symptoms, with ~1.5 additional CSBMs a week. The capsule improves patient comfort levels, making them feel completely evacuated, with better stool consistency, and without diarrhea – the leading discomfort associated with constipation drugs.
Patients will report to the Vibrant system both automatically and manually on their evacuations and their adherence to the treatment regimen. Physicians will be able to adjust the “dose” remotely and be notified by the system of any issue that requires their attention.
Building on the capsule’s excellent results, Vibrant is developing a capsule that will operate differently in various sections of the colon, or only in selected sections, as per diagnosis and treatment protocol. This will boost dose response, enable non-responders to become effective responders, and provide desirable effects via the minimal dose of capsules per week.