Motegrity

refractory Chronic idiopathic constipation, Opioid-Induced Constipation, chronic idiopathic constipation (CIC)

Treatment

2 FDA approvals

1 Active Study for Motegrity

What is Motegrity

Prucalopride

The Generic name of this drug

Treatment Summary

Prucalopride is a medication used to treat chronic constipation. It works by activating serotonin receptors in the gut, promoting the movement of food through the digestive tract. Prucalopride was developed by Shire Development LLC and approved for use in Europe in 2009 and in Canada in 2011. It was approved for use in the United States by the FDA in 2018.

Motegrity

is the brand name

image of different drug pills on a surface

Motegrity Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Motegrity

Prucalopride

2018

2

Approved as Treatment by the FDA

Prucalopride, otherwise called Motegrity, is approved by the FDA for 2 uses including refractory Chronic idiopathic constipation and chronic idiopathic constipation (CIC) .

refractory Chronic idiopathic constipation

chronic idiopathic constipation (CIC)

Effectiveness

How Motegrity Affects Patients

Prucalopride is a drug that helps to speed up how quickly food moves through the colon and intestines. Studies in animals have shown that it increases the contractions in the beginning part of the colon, and slows down contractions in the end part. It also increases a type of contraction that signals the body to go to the bathroom. In clinical trials, people taking prucalopride had more bowel movements than those taking a placebo. Most people who tried it liked it and wanted to keep taking it. Finally, the trials showed that more people taking prucalopride had more than 3 bowel movements per week than those

How Motegrity works in the body

Prucalopride works by targeting certain receptors in your digestive system. It stimulates 5-HT4 receptors, which release a chemical called acetylcholine that helps to contract the muscles in your colon and relax the circular muscles, which helps to move food through your digestive system. Prucalopride does not interact with other receptors, such as hERG channel or 5-HT1, which helps reduce the risk of cardiovascular side effects.

When to interrupt dosage

The advised portion of Motegrity is contingent upon the confirmed condition, including Opioid-Induced Constipation, obdurate Chronic idiopathic constipation and chronic idiopathic constipation (CIC). The dosage amount is contingent upon the delivery approach (e.g. Tablet - Oral or Tablet) featured in the table beneath.

Condition

Dosage

Administration

refractory Chronic idiopathic constipation

, 1.0 mg, 2.0 mg

, Tablet, Oral, Tablet - Oral, Tablet, film coated - Oral, Tablet, film coated

Opioid-Induced Constipation

, 1.0 mg, 2.0 mg

, Tablet, Oral, Tablet - Oral, Tablet, film coated - Oral, Tablet, film coated

chronic idiopathic constipation (CIC)

, 1.0 mg, 2.0 mg

, Tablet, Oral, Tablet - Oral, Tablet, film coated - Oral, Tablet, film coated

Warnings

Motegrity Contraindications

Condition

Risk Level

Notes

Ulcerative Colitis

Do Not Combine

Ileus

Do Not Combine

Intestinal Perforation

Do Not Combine

Intestinal Obstruction

Do Not Combine

Megacolon, Toxic

Do Not Combine

Crohn's Disease

Do Not Combine

Dialysis therapy

Do Not Combine

Severe Hypersensitivity Reactions

Do Not Combine

Prucalopride may interact with Pulse Frequency

There are 20 known major drug interactions with Motegrity.

Common Motegrity Drug Interactions

Drug Name

Risk Level

Description

Acrivastine

Minor

Prucalopride may decrease the excretion rate of Acrivastine which could result in a higher serum level.

Albutrepenonacog alfa

Minor

Prucalopride may decrease the excretion rate of Albutrepenonacog alfa which could result in a higher serum level.

Alloin

Minor

The risk or severity of adverse effects can be increased when Prucalopride is combined with Alloin.

Almasilate

Minor

Prucalopride may decrease the excretion rate of Almasilate which could result in a higher serum level.

Ammonium chloride

Minor

Prucalopride may decrease the excretion rate of Ammonium chloride which could result in a higher serum level.

Motegrity Toxicity & Overdose Risk

Prucalopride is generally safe to take in doses up to 10 times the recommended amount. Signs of overdose are usually mild and can include headaches, nausea, and diarrhea. In mice, a dose of 80mg/kg/day may result in mammary gland adenocarcinoma, while in rats high doses may lead to benign tumors in the adrenal glands, pituitary, pancreas, liver, and thyroid. Prucalopride has been tested for its ability to cause genetic mutations and no serious effects were found at high concentrations. There is also no evidence that prucalopride has any negative effects

image of a doctor in a lab doing drug, clinical research

Motegrity Novel Uses: Which Conditions Have a Clinical Trial Featuring Motegrity?

One active clinical trial is investigating the possibility of utilizing Motegrity to alleviate Opioid-Induced Constipation, chronic idiopathic constipation (CIC) and refractory Chronic idiopathic constipation.

Condition

Clinical Trials

Trial Phases

refractory Chronic idiopathic constipation

0 Actively Recruiting

Opioid-Induced Constipation

0 Actively Recruiting

chronic idiopathic constipation (CIC)

1 Actively Recruiting

Phase 2, Phase 3

Motegrity Reviews: What are patients saying about Motegrity?

5

Patient Review

7/8/2022

Motegrity for Chronic Difficulty having a Bowel Movement

This is the only medication that has worked for me after trying many different ones (Linzess, Amitiza, etc). It takes a little bit of time to get used to, but it's worth it. I would definitely recommend this to others.

4.3

Patient Review

12/10/2019

Motegrity for Chronic Difficulty having a Bowel Movement

I unfortunately had a really negative reaction to this medication. A few hours after my first dose I was incredibly ill with symptoms like insomnia, sweats, muscle spasms, and nausea. However, it did work in that I had a bowel movement the next morning and everyday after. Still hoping I'll adjust though.

4.3

Patient Review

8/1/2020

Motegrity for Chronic Difficulty having a Bowel Movement

Despite the nausea and cramps I experience in the morning, this treatment regimen has been worth it because it generally leads to full evacuation for me.

4.3

Patient Review

8/1/2020

Motegrity for Chronic Difficulty having a Bowel Movement

Even though this regimen of medication and treatments causes me a lot of nausea and cramps in the morning, it's worth it because I generally fully evacuate.

4

Patient Review

6/26/2022

Motegrity for Chronic Difficulty having a Bowel Movement

I started using this medication less than a month ago and, while it has been effective, I've experienced every single one of the listed side effects. I'm going to continue taking it for now and see how I feel in a few weeks. constipation is a real issue for me and this is the first time I've found anything that helps with that.

3

Patient Review

3/18/2022

Motegrity for Chronic Difficulty having a Bowel Movement

This drug works very well for its intended purpose. However, it comes with the serious side effect of severe depression and suicidal ideation. If you have a history of mental illness or have reacted badly to SSRIs in the past, I would exercise caution before taking this medication.

3

Patient Review

6/13/2021

Motegrity for Chronic Difficulty having a Bowel Movement

This drug helped with my constipation, but the stomach cramps it caused were really intense and long-lasting. I stopped taking it after two weeks and will be trying a different laxative instead.

2.7

Patient Review

1/2/2020

Motegrity for Chronic Difficulty having a Bowel Movement

At first this was helpful, but then it stopped working and made my headaches worse. I also started having suicidal thoughts, which is obviously a huge red flag.

2.3

Patient Review

4/22/2020

Motegrity for Chronic Difficulty having a Bowel Movement

I got terrible diarrhea from this, to the point of dehydration. It's by far one of the worst laxatives I've ever taken.

2.3

Patient Review

8/29/2019

Motegrity for Chronic Difficulty having a Bowel Movement

Unfortunately, this medication caused me a great deal of discomfort due to excessive gas. Additionally, it wasn't all that effective. I strongly advise against taking this drug.

2

Patient Review

9/16/2022

Motegrity for Chronic Difficulty having a Bowel Movement

I started taking Motegrity about a week ago and have not found it to be helpful at all.

2

Patient Review

7/19/2022

Motegrity for Chronic Difficulty having a Bowel Movement

I experienced some really uncomfortable side effects after taking this pill. I would rather stick with my current medication.

1.7

Patient Review

10/3/2022

Motegrity for Chronic Difficulty having a Bowel Movement

If you have a history of migraines, I would highly recommend avoiding this medication. Unfortunately, I didn't know that and ended up having one of the most severe migraines of my life.

1

Patient Review

11/30/2019

Motegrity for Chronic Difficulty having a Bowel Movement

I used this product for seven weeks with little results in the beginning, but no results since then. Additionally, I experienced very severe gas, bloating and abdominal pain from this treatment. Therefore, I will not be using it again.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about motegrity

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the side effects of Motegrity?

"The most common side effects of Motegrity include: headaches, stomach pain or bloating, nausea, diarrhea, dizziness, vomiting, gas, and fatigue. These side effects are typically mild and go away after a few days of continued use."

Answered by AI

What is the difference between linzess and Motegrity?

"Linzess and Motegrity work differently in the body, but they share some common side effects, including diarrhea, stomach/abdominal pain or discomfort, gas, bloating, vomiting, and headache."

Answered by AI

Is Motegrity an opioid?

"The drugs Viberzi and Motegrity are approved to treat chronic idiopathic constipation in adults. Viberzi is a mu-opioid receptor agonist and Motegrity is a serotonin-4 (5-HT4) receptor agonist."

Answered by AI

What is Motegrity supposed to do?

"MOTEGRITY is a prescription medicine used to treat a type of constipation called chronic idiopathic constipation (CIC) in adults. The cause of CIC is unknown. MOTEGRITY has not been studied in children and it is not known if it is safe and effective for them."

Answered by AI

Clinical Trials for Motegrity

Image of Children's Hospital Los Angeles in Los Angeles, United States.

Maralixibat for Cystic Fibrosis and Constipation

1 - 18
All Sexes
Los Angeles, CA

Chronic constipation is a feature of children with cystic fibrosis (CF). This is postulated to be a result of inhibition of secretory activity of the gastrointestinal luminal cells due to ineffective chloride channel function. Typical laxatives that work as osmotic agents fail to produce adequate relief in this population. Maralixibat is a non-systemic bile acid transport inhibitor (IBATi) that acts by interrupting bile acid reabsorption in the ileum thus interrupting the normal enterohepatic circulation. This interruption results in a larger volume of bile acids reaching the colon and being excreted in stool. Bile acids are known to decrease bowel transit time, increase mucosal permeability and secretions, as well as alter gut microbiota resulting in diarrhea. The overarching hypothesis of the study is that Maralixibat will improve stool consistency in children (Age \<18 years) with cystic fibrosis and constipation (Bristol Stool Scale \<4). Specifically, we aim to test the hypothesis that IBATi improves the consistency of stool to Bristol scale \>4 in children with CF and constipation. We will recruit a total of 20 patients with CF and constipation (defined as Bristol Stool Scale \<4 for 1 week prior to enrollment while on a stable laxative regimen for at least 4 weeks.) Design is a 'Within-Subjects' study by which each enrolled patient will take Maralixibat for 2 weeks total in addition to their stable laxative regimen during the study. Stool consistency \& ease of defecation will be recorded before and during the study period by families of enrolled patients via materials provided by the investigators. Stool consistency and ease of defecation will be compared before and after initiation of Maralixibat. The primary endpoint: Improvement in stool consistency to Bristol scale \>4 in children with CF and constipation. The secondary endpoint: Improvement in ease of defecation in children with CF and constipation. This will be measured via survey using a standardized scale (Bristol Stool Scale) and questionnaires developed by the research team. Analysis will involve comparison of pre-intervention to post-intervention stool consistency \& survey

Phase 2 & 3
Waitlist Available

Children's Hospital Los Angeles

Jaya Punati, MD