Constipation Awareness Month: Potential breakout therapies to watch in 2023
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Chronic constipation affects up to 20% of adults and 16% of children in the U.S, therefore the International Foundation for Gastrointestinal Disorders recognized December as Constipation Awareness Month.
According to the organization, constipation is a difficult gut symptom to define because it appears differently in individuals. Those who suffer from constipation may report having reduced stool frequency, hard stools, difficult passing stools, straining, painful bowel movements and feeling incomplete emptying after defecation.
Healio has followed the latest news on constipation including meeting coverage from the ACG Annual Scientific Meeting and Digestive Disease Week and research published in gastroenterology journals including results on Linzess, Relistor, plecanatide, vibrating capsules and electrical stimulation.
Want to see what you missed? We have compiled a list of the constipation-related news from throughout 2022 for Constipation Awareness Month regarding potential treatments that could relieve patients’ symptoms.
Linzess safely improves bowel movement, consistency in pediatric functional constipation
Ironwood Pharmaceuticals Inc. announced positive results from its phase 3 trial that evaluated Linzess for the treatment of pediatric patients with functional constipation, according to a company press release.
In a randomized, double-blind, parallel group study, 330 pediatric patients with functional constipation aged 6 to 17 years received either Linzess (linaclotide 72 mcg, AbbVie/Ironwood) or placebo. In a Healio interview exclusive, Susanna Huh, MD, MPH, head of clinical development and research for Ironwood Pharmaceuticals, said Linzess induced a “statistically significant and clinically meaningful improvement compared with placebo in 12-week spontaneous bowel movement frequency,” and a greater than two-fold least squares mean change from baseline per week compared with placebo. Researchers also observed improved stool consistency. Read more.
Relistor produces rescue-free laxation in patients with opioid-induced constipation
A single dose of Relistor injection produced rescue-free laxation in severely ill patients with opioid-induced constipation who had an insufficient response to laxative therapy, according to a study published in the Journal of Emergency Medicine.
“Methylnaltrexone (Relistor) works in the majority of opioid-induced constipation patients within four hours, and its use doesn’t change the analgesic effects of the opioid,” W. Frank Peacock, MD, FACEP, FACC, lead author and director of research at Baylor College of Medicine in Houston, told Healio. Read more.
Daily plecanatide boosts bowel movement in chronic idiopathic constipation, IBS-C
Once daily plecanatide effectively relieved symptoms in patients of varying age with chronic idiopathic constipation and irritable bowel syndrome-constipation, according to a poster at the ACG Annual Scientific Meeting.
“This analysis was conducted to further assess the potential impact of age on the efficacy and safety of plecanatide in an analysis of adults with [chronic idiopathic constipation] or IBS-C,” Kyle Staller, MD, director of the Gastrointestinal Motility Laboratory at Massachusetts General and assistant professor of medicine at Harvard Medical School, told Healio. Read more.
Vibrating capsule safe, well tolerated, easy to use in chronic idiopathic constipation
An orally ingested vibrating capsule was found to be safe, well tolerated and easy to use for the treatment of chronic idiopathic constipation, according to data presented at the ACG Annual Scientific Meeting.
“The study represents the safety and harms data that was collected during a phase 3 randomized, controlled trial comparing the vibrating capsule to a sham capsule in patients with chronic idiopathic constipation,” William D. Chey, MD, H. Marvin Pollard Professor of Gastroenterology and professor of nutrition sciences and chief of gastroenterology and hepatology at Michigan Medicine, told Healio. Read more.
Linzess safely improves bowel movement, consistency in pediatric functional constipation
Ironwood Pharmaceuticals Inc. announced positive results from its phase 3 trial that evaluated Linzess for the treatment of pediatric patients with functional constipation, according to a company press release.
In a randomized, double-blind, parallel group study, 330 pediatric patients with functional constipation aged 6 to 17 years received either Linzess (linaclotide 72 mcg, AbbVie/Ironwood) or placebo. In a Healio interview exclusive, Susanna Huh, MD, MPH, head of clinical development and research for Ironwood Pharmaceuticals, said Linzess induced a “statistically significant and clinically meaningful improvement compared with placebo in 12-week spontaneous bowel movement frequency,” and a greater than two-fold least squares mean change from baseline per week compared with placebo. Researchers also observed improved stool consistency. Read more.
Relistor produces rescue-free laxation in patients with opioid-induced constipation
A single dose of Relistor injection produced rescue-free laxation in severely ill patients with opioid-induced constipation who had an insufficient response to laxative therapy, according to a study published in the Journal of Emergency Medicine.
“Methylnaltrexone (Relistor) works in the majority of opioid-induced constipation patients within four hours, and its use doesn’t change the analgesic effects of the opioid,” W. Frank Peacock, MD, FACEP, FACC, lead author and director of research at Baylor College of Medicine in Houston, told Healio. Read more.
VIDEO: Patient compliance with vibrating capsule linked to improved constipation outcomes
In a Healio video exclusive, Eamonn Quigley, MD, reported increased compliance to an orally ingested vibrating capsule predicted positive outcomes among patients with chronic idiopathic constipation.
In an 8 week, randomized, double-blind phase 3 trial, Quigley, a gastroenterology specialist at Houston Methodist, and colleagues evaluated the impact of compliance on the efficacy of the vibrating capsule. Patients with chronic idiopathic constipation (CIC) received either orally ingested vibrating capsules (n = 163) or placebo (n = 149). Watch here.
Electrical stimulation alleviates abdominal pain, symptoms in IBS with constipation
Transcutaneous electrical acustimulation improved abdominal pain and constipation symptoms in patients with irritable bowel syndrome compared with a sham procedure, according to a study published in American Journal of Gastroenterology.
“In the past few years, transcutaneous electrical acustimulation (TEA), a noninvasive method that replaces needles [with] surface electrodes, has been found to improve chronic constipation, postoperative recovery, abdominal pain and functional dyspepsia,” Zhihui Huang, PhD, of Sir Run Run Shaw Hospital at Zhejiang University School of Medicine in China, and colleagues wrote. “However, it is unknown whether TEA is capable of concurrently improving constipation and abdominal pain.” Read more.
Rectal expulsion device may predict outcomes in patients with chronic constipation
SAN DIEGO — An investigational, point-of-care rectal expulsion device may help determine whether patients with chronic constipation will improve with pelvic floor physical therapy, according to data presented at Digestive Disease Week 2022.
“[Rectal expulsion device (RED)] was specifically designed to simplify and pull the tertiary care paradigm of anorectal function testing downstream to any general gastroenterologists’ medical office for patients with chronic constipation,” Eric D. Shah, MD, MBA, assistant professor at Dartmouth College Geisel School of Medicine and Dartmouth-Hitchcock Medical Center in New Hampshire, told Healio. Read more.
Plecanatide decreases severity of abdominal pain, bloating in IBS-C
CHARLOTTE, N.C. — Once daily plecanatide decreased symptom severity among patients with irritable bowel syndrome-constipation and severe abdominal pain and bloating, according to a poster presented at the ACG Annual Scientific Meeting.
“The objective of this analysis was to evaluate the efficacy of plecanatide for improving severe abdominal pain and/or severe bloating in patients with IBS-C,” Gregory S. Sayuk, MD, MPH, associate professor of gastroenterology at Washington University School of Medicine, told Healio. Read more.
AbbVie submits sNDA for functional constipation treatment in pediatric patients
AbbVie announced that it has submitted a supplemental new drug application for Linzess for the treatment of functional constipation in patients aged 6 to 17 years, according to a press release.
The submission is supported by data from a multicenter double-blind phase 3 study that investigated the efficacy of Linzess (linaclotide 72 mcg, AbbVie/Ironwood) in treating functional constipation across a total of 330 patients who were randomized in a 1:1 ratio between Linzess or placebo. Read more.