About My Health Careers Internship MedBlogs Contact us
Medindia LOGIN REGISTER
Advertisement

Experimental Drug can Solve Constipation Problems Posed by Pain Medicines

by Kathy Jones on June 5, 2014 at 8:25 PM
Font : A-A+

 Experimental Drug can Solve Constipation Problems Posed by Pain Medicines

Researchers at University of Michigan Health System revealed that an experimental drug that is to be taken once every day can provide a solution to constipation problems experienced by patients who take pain medicines for long-term pain relief.

Globally, approximately 28 million to 35 million, or nearly half, of patients taking opioids for long-term pain develop constipation. Laxatives provide sub-optimal relief.

Advertisement

The results of two pivotal Phase 3 studies - KODIAC-4 and KODIAC-5 of naloxegol, an investigational treatment for opioid-induced constipation (OIC) - were published online first in the New England Journal of Medicine.

A 25 mg dose of the investigational drug naloxegol safely increased bowel movements among opioid-induced constipation sufferers, compared to a placebo, and the effects were maintained over a 12-week treatment period.
Advertisement

"The studies showed rapid and sustained improvement for these patients, without compromising their pain management," says lead study author and gastroenterologist William Chey, M.D., professor of internal medicine at the U-M Health System.

Naloxegol is an investigational peripherally-acting mu-opioid receptor antagonist, which has been specifically designed for the treatment of opioid-induced constipation (OIC), a common and often debilitating side effect of prescription medicines used to treat osteoarthritis and chronic back pain.

Opioids play an important role in chronic pain relief by binding to mu-receptors in the brain, blocking the brain's ability to perceive brain. But they also bind to mu-receptors in the bowel, contributing to constipation.

Naloxegol is designed to block the binding of opioids to receptors in the gastrointestinal tract without impacting the opioid receptors in the brain.

The Phase III studies known as KODIAC, enrolled 652 people in one trial and 700 in another. The 12-week, multicenter, randomized, double blind, placebo-controlled pivotal trials evaluated 12.5 mg and 25 mg doses of naloxegol, once-daily.

The most commonly reported adverse effects with naloxegol were abdominal pain, diarrhea, nausea, vomiting, flatulence and appeared to be dose-ordered, occurring more commonly in the 25 mg group.

Most adverse events were mild to moderate in severity and occurred shortly after initiation of naloxegol. There was one major cardiovascular adverse event in the 25 mg treatment group, one in the 12.5 mg treatment group and two among those in the placebo group.

A New Drug Application (NDA) for naloxegol was accepted by the US Food and Drug Administration on Nov. 19, 2013. Naloxegol is also under regulatory review with health agencies in the European Union and Canada.



Source: Eurekalert
Advertisement

Advertisement
News A-Z
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
News Category
What's New on Medindia
Printed Temperature Sensors help with Continuous Temperature Monitoring
Health Benefits of Giloy
Breast Cancer Awareness Month 2021 - It's time to RISE
View all

Medindia Newsletters Subscribe to our Free Newsletters!
Terms & Conditions and Privacy Policy.

More News on:
Drug Toxicity Constipation Piles Colo-rectal cancer - Management Signature Drug Toxicity Piles Treatment Options Irritable Bowel Syndrome Fiber Up Your Meals The Better Flour - Refined Or Whole Wheat Flour! Constipation-Symptom Evaluation 

Recommended Reading
Constipation
Constipation, or difficulty passing stool, is a common digestive complaint and is a symptom of ......
Constipation-Symptom Evaluation
Constipation can occur due to a number of factors from faulty bowel habits, digestive tract ......
Toddler Constipation
Toddler constipation is non-passage of stool/ motion by child for 4 days or more. Toddler ......
Colo-rectal cancer - Management
Treatment for Colorectal Cancers may involve surgery,chemotherapy, radiation therapy or biological t...
Drug Toxicity
Drug toxicity is an adverse reaction of the body towards a drug that results as a side effect of a d...
Fiber Up Your Meals
A high fiber diet and good water intake are essential for a stress free body. High-fiber foods preve...
Irritable Bowel Syndrome
Irritable bowel syndrome (IBS) causes recurrent abdominal pain or discomfort and a fluctuating distu...
The Better Flour - Refined Or Whole Wheat Flour!
Whole wheat flour is rapidly gaining exposure for its rich nutritional value and being considered he...

Disclaimer - All information and content on this site are for information and educational purposes only. The information should not be used for either diagnosis or treatment or both for any health related problem or disease. Always seek the advice of a qualified physician for medical diagnosis and treatment. Full Disclaimer

© All Rights Reserved 1997 - 2021

This site uses cookies to deliver our services. By using our site, you acknowledge that you have read and understand our Cookie Policy, Privacy Policy, and our Terms of Use