The results of 2 phase 3 studies of naloxegol, an investigational treatment for opioid-induced constipation (OIC), showed that the investigational drug safely increased bowel movements among patients suffering from constipation due to opioid use.
The findings were published first in the New England Journal of Medicine.
“The studies showed rapid and sustained improvement for these patients, without compromising their pain management,” said lead author William Chey, MD, University of Michigan Health System, Ann Arbor, Michigan.
Naloxegol is an investigational peripherally-acting mu-opioid receptor antagonist, which has been specifically designed for the treatment of opioid-induced constipation, 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 3 studies known as KODIAC enrolled 652 people in 1 trial and 700 in another. The 12-week, multicentre, randomised, double blind, placebo-controlled pivotal trials evaluated once daily naloxegol 12.5 mg and naloxegol 25 mg.
The most commonly reported adverse effects with naloxegol were abdominal pain, diarrhoea, nausea, vomiting, flatulence, which 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 1 major cardiovascular adverse event in the 25 mg treatment group, 1 in the 12.5 mg treatment group, and 2 in the placebo group.
SOURCE: University of Michigan Health System