Vibrant: An innovative, drug-free treatment proven to relieve your patients’ chronic idiopathic constipation

A different approach to a common problem

Constipation—the most common digestive complaint, affecting 16% of the general population—is associated with substantial economic costs.1

Indication

Vibrant is indicated 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.

Unique mechanism of action designed to stimulate the colon’s natural rhythm

In patients with chronic idiopathic constipation (CIC), colon activity is often out of sync. Vibrant is a capsule that, when activated and swallowed, sends out pulsed micro-vibrations to stimulate the colon locally, which induces peristalsis and helps the colon contract mechanically, synchronizing with its biological clock.2

Proven effective and safe in clinical trials

Vibrant is a novel, non-pharmacological, intraluminal therapy that is proven to be efficacious and safe in patients with chronic idiopathic constipation (CIC).2

It is indicated 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.

Study design

Randomized, double-blind, multi-center, placebo-controlled phase 3 clinical trial with 312 adult patients diagnosed with chronic idiopathic constipation.

The primary efficacy endpoints were an increase of 1 or more complete spontaneous bowel movements per week (CSBM responder) or 2 or more CSBMs per week (CSBM ) from baseline during at least 6 of the 8 weeks.

Significant improvements across all efficacy measures

Primary Endpoints

Significant improvement in incremental CSBMs
P-value
p=0.001
P-value
p=0.008
Proportion of responders (95% CI)
40%
30%
20%
10%
0%
39.3%
22.1%
22.7%
11.4%
+1 CSBM/wk
+2 CSBM/wk
Incremental CSBM (Complete Spontaneous Bowel Movement)

Treatment Arm

Vibrant

Placebo

  • Vibrant Capsule led to one additional bowel movement in approximately 40% of patients compared with 23% of people who were in the control arm.2
  • Approximately 23% of people taking Vibrant had two additional bowel movements per week, compared with approximately 12% of people taking placebo.2

Secondary Endpoints

Improvement in overall
constipation symptoms

Straining Score

0
-0.4
-0.8
-1.2
-1.6
-1.8
-1.0
-1.56
P-value
0.0126

Stool Consistency

1
0.8
0.6
0.4
0.2
0
P-value
<0.0001
0.44
0.92
Improvement in QoL from baseline (using PAC-QOL questionnaire)
100%
80%
60%
40%
20%
P-value
=0.002
77.9%
62.9%
Improvement in overall
Constipation symptoms

Straining Score

0
-0.4
-0.8
-1.2
-1.6
-1.8
-1.0
-1.56
P-value
0.0126

Stool Consistency

1
0.8
0.6
0.4
0.2
0
P-value
<0.0001
0.44
0.92
Improvement in QoL from baseline (using PAC-QOL questionnaire)
100%
80%
60%
40%
20%
P-value
=0.002
77.9%
62.9%

Treatment Arm

Vibrant

Placebo

Adverse events observed in this clinical trial
Vibrant
Placebo
Gastrointestinal disorders - total
Vibrant
6.13%
Placebo
9.40%
Abdominal pain
Vibrant
0.61%
Placebo
4.03%
Vomiting
Vibrant
1.23%
Placebo
0.67%
Nausea
Vibrant
1.84%
Placebo
0.67%
Abdominal distension
Vibrant
0.61%
Placebo
1.34%
Diarrhea
Vibrant
1.23%
Placebo
-
Adverse events were mild, gastrointestinal in nature, and similar between groups.

Conclusions

Vibrant demonstrated significant improvement in

  • stool frequency, which was seen as early as week 1 and continued throughout the study.
  • other bowel and abdominal symptoms and quality of life.

The regimen established tolerability with no significant adverse events.

Vibrant provides a novel, non-pharmacological, intraluminal therapy that is effective, safe, and well tolerated in patients with CIC.2

See key thought leaders respond to the clinical data for Vibrant

Vibrant should not be used if your patient

  • has a history of complicated/obstructive diverticular disease.
  • has a history of intestinal or colonic obstruction, or suspected intestinal obstruction.
  • currently has clinical evidence of significant gastroparesis.
  • has a history of significant gastrointestinal disorder, including any form of inflammatory bowel disease or gastrointestinal malignancy (celiac disease is excepted if the subject has been treated and is in remission), and/or anal fissures and fistulas.
  • has a history of Zenker’s diverticulum, dysphagia, esophageal stricture, eosinophilic esophagitis, or achalasia.
  • is pregnant or lactating.

Adverse events/side effects:

Potential adverse events associated with the use of this device may include abdominal pain, abdominal distension, abdominal discomfort, vomiting, nausea, blood in stool, diarrhea, flatulence, and proctalgia. In rare cases, obstruction may occur.

Note that the safety and effectiveness of the Vibrant System for long-term use in the indicated population, i.e., for more than 8 weeks, has not been evaluated.

Warnings:

  • The Vibrant Capsule is MR unsafe. The device has not been evaluated for safety and compatibility in the MR (magnetic resonance) environment. It has not been tested for heating, migration, or image artifact in the MR (magnetic resonance) environment. If patient requires an MRI, verify Capsule expulsion via abdominal X-ray before undergoing an MRI examination.
  • The Capsule should be kept away from implants such as pacemakers, defibrillators, nerve stimulators, and other devices that could be affected by proximity to a DC (direct current) magnetic field.
  • Vibrant Capsules must be stored in a safe place, out of the reach of children and/or infants.
  • If a child has accidentally swallowed an unused Vibrant Capsule, he/she should be brought immediately to a hospital.
  • The Vibrant Capsule is magnetic resonance (MR) unsafe. If an MRI is required, verify that no Capsules are currently in your body via abdominal X-ray before undergoing an MRI examination.

Contact us about patient options for participating in our post-market clinical data collection.

 

How to prescribe

Select Vibrant in your EHR

* For a new patient – select code 60009-0189-82
* For a monthly refill – select code 60009-0189-80

In the prescription notes, include the patient’s ICD-10 diagnosis code(s) as well as any previous use of prescription constipation medications.

How to choose Carepoint in your EHR
* Search by zip code – 60173
* Verify address of pharmacy prior to sending prescription – 9 E. Commerce Drive, Schaumburg, IL
* Add to favorites for convenience

Please note that Vibrant is available only via Carepoint.
You can also fax the prescription directly to (855) 237-9113.

Product NameVibrant Starter Kit
NDC60009-0189-82
IndicationTreatment of chronic idiopathic constipation
Dosage FormCapsule
Dispense Quantity1
Dispense Unit1 ea Box
Number of Supply in One Box1 Pod, 20 Capsules
Days Supply30 days
SIGAs directed by a physician. Orally ingested up to 5 times per week. The Capsules should be taken once daily, on any of the 5 days out of the week, shortly before going to sleep.
Notes to PharmacistRelevant ICD-10 Code for CIC and examples of previous medications tried and failed for treatment may streamline Prior Authorization Process
Specialty PharmacyCarepoint Pharmacy 9 E. Commerce Drive Schaumburg, IL 60173 (855) 237-9112

Example Dosing Screenshot:

Product NameVibrant Capsule (Refill)
NDC60009-0189-80
IndicationTreatment of chronic idiopathic constipation
Dosage FormCapsule
Dispense Quantity20
Dispense UnitCapsule
Number of Supply in One Box20 Capsules
Days Supply30 days
SIGAs directed by a physician. Orally ingested up to 5 times per week. The Capsules should be taken once daily, on any of the 5 days out of the week, shortly before going to sleep.
Notes to PharmacistRelevant ICD-10 Code for CIC and examples of previous medications tried and failed for treatment may streamline Prior Authorization Process
Specialty PharmacyCarepoint Pharmacy 9 E. Commerce Drive Schaumburg, IL 60173 (855) 237-9112

Example Dosing Screenshot:

If you can’t find Vibrant in your EHR or have questions, email us at [email protected]

3 simple steps to relief with Vibrant

1. Activate

The patient places the Capsule in the Pod for an automatic activation.

2. Ingest

The patient swallows the activated Capsule with a full 8 oz. glass of water.

3. Monitor

For the best experience, encourage patients to monitor their treatment using the free Vibrant app, downloadable from any app store.