Constipation And Bowel Cleansers

Tenapanor NDA Submitted for Irritable Bowel Syndrome With Constipation

By September 14, 2018

Tenapanor, a minimally-systemic small molecule, inhibits the sodium transporter NHE3 and reduces sodium absorption in the gastrointestinal tract, thus increasing intestinal fluid.

New Bowel Prep Option for Colonoscopy Gets FDA Approval

By May 07, 2018

The approval of Plenvu was based on multiple clinical trials including the NOCT study which compared Plenvu to the trisulfate bowel cleansing solution Suprep (sodium sulfate, potassium sulfate, magnesium sulfate oral solution; Braintree Laboratories) using a 2-day evening/morning split-dosing regimen.

FDA Accepts NDA for Novel Chronic Idiopathic Constipation Treatment

By March 05, 2018

If approved, prucalopride will be the only readily available 5-HT4 agonist for adult CIC in the U.S.

Treatment With Homemade Enema Leads to Colitis in Two Children

By February 14, 2018

A national survey showed that only about 7% of consumers read warning labeling on over-the-counter products.

Ready-to-Drink Clenpiq Now Available for Colonoscopy Prep

By February 12, 2018

Clenpiq is indicated for cleansing of the colon as a preparation for colonoscopy in adults.

Efficacy of Linaclotide, Plecanatide Evaluated for CIC, IBS-C Treatment

By January 31, 2018

There was no significant difference between the two therapies in odds ratios for efficacy, diarrhea, or diarrhea-related study withdrawals.

Trulance Gains New Indication for IBS With Constipation

By January 25, 2018

Apart from a single amino acid substitution, Trulance is structurally identical to human uroguanylin and is thought to replicate the pH-sensitive activity of uroguanylin.

Recall: Bottle Labeled as Laxative May Contain NSAID Instead

By January 22, 2018

Distributors have been notified by the company and a return of the Lot is being arranged. Consumers and retailers in possession of Lot #352300 should return the product to Magno-Humphries Laboratories.

Ready-to-Drink Colonoscopy Prep Solution Gains FDA Approval

By November 29, 2017

Clenpiq will become the only FDA-approved colonoscopy prep that is 'ready-to-drink'. The solution is cranberry-flavored and the Company says it is expected to be available in Q1 of 2018.

Defecation Posture Modification Device Found to Be Beneficial

October 16, 2017

Significant reductions in bowel movement duration, straining patterns and increase in bowel emptiness

Symproic Now Available for Opioid-Induced Constipation

By October 12, 2017

Symproic, initially approved as a CII controlled substance in March 2017, was officially descheduled by the Drug Enforcement Agency (DEA) in September 2017.

Concomitant Naloxegol Tx Evaluated for Opioid Dose Impact

September 21, 2017

The researchers found that the mean daily numerical rating scale average pain scores varied from 4.5 to 4.8 for all groups in the 652 participants in KODIAC-04, and were 4.6 for each group of the 700 participants in KODIAC-05.

Labeling Updated for Multiple Drugs Indicated for Opioid-Induced Constipation

By August 07, 2017

The prescribing information has been updated to provide clarification of the opioid-induced constipation (OIC) indication.

Stool Softeners Recalled Due to Possible Contamination

By August 03, 2017

Rugby Laboratories announced a voluntary recall of all lots of Diocto Liquid and Diocto Syrup (docusate sodium solutions) due to a risk of contamination with Burkholderia cepacia.

FDA to Review Trulance for IBS-C Indication in Adults

By June 07, 2017

Results from both studies showed Trulance was statistically superior to placebo in achieving the primary endpoint (Study 1: 30.2%, P<0.001 in 3mg and 29.5% in 6mg vs. 17.8% in placebo; Study 2: 21.5% in 3mg and 24.0% in 6mg vs. 14.2% in placebo).

How Common are Adverse GI Events with Statin Therapy?

By April 17, 2017

The analyses found no statistically significant difference between statin use and lower gastrointetinal conditions in constipation (OR 0.96, 95% CI: 0.87-1.05; P=0.33), abdominal pain (OR 0.95, 95% CI: 0.88-1.02; P=0.15), or colitis (OR 1.02, 95% CI: 0.91-1.14; P=0.73).

Synergy Seeks IBS-C Indication for Trulance

By March 28, 2017

The new application for an IBS-C indication is supported by data from two placebo-controlled Phase 3 studies that lasted 12 weeks and evaluated plecanatide in 2,100 patients with IBS-C.

New Dosage Strength for Linzess Approved

By January 26, 2017

Ironwood and Allergan announced that the Food and Drug Administration (FDA) has approved a new 72mcg dose of Linzess (linaclotide) for the treatment of chronic idiopathic constipation (CIC) in adults.

FDA Approves Unique Treatment for Chronic Idiopathic Constipation

By January 20, 2017

Trulance (plecanatide; Synergy) has been approved by the Food and Drug Administration (FDA) for the treatment of chronic idiopathic constipation (CIC) in adult patients.

Non-Drug Therapy Found to Help Children with Functional Constipation

January 03, 2017

More effective than standard medical care for most outcomes in children with functional constipation

Plecanatide Shows Promise for Treating IBS With Constipation

By December 09, 2016

Synergy has announced results from the first two pivotal Phase 3 trials evaluating plecanatide in patients with irritable bowel syndrome with constipation (IBS-C).

Constipation Drug Labeling Updated to Warn of Syncope, Hypotension

By October 17, 2016

Clinicians are advised to make patients aware of the risk.

Long-Term Safety Data for Novel Chronic Idiopathic Constipation Drug Announced

By October 17, 2016

At the American College of Gastroenterology (ACG) annual scientific meeting, Synergy presented new long-term safety data of plecanatide for the treatment of chronic idiopathic constipation (CIC).

Lubiprostone Significantly Improves Abdominal Pain, Bloating in IBS-C

By September 29, 2016

Lubiprostone was significantly more effective in improving abdominal pain or bloating than placebo, according to results from a post-hoc analysis published in Alimentary Pharmacology and Therapeutics.

Antidepressant Efficacy Evaluated in Pediatric Abdominal Pain

By September 28, 2016

The review included children aged 5-21 years with functional abdominal pain treated with SSRI or TCA.

Acupuncture for Chronic Severe Functional Constipation Explored

By September 13, 2016

Data from a study published in Annals of Internal Medicine found that eight weeks of electroacupuncture increased complete spontaneous bowel movements (CSBMs) and was safe for the treatment of chronic severe functional constipation (CSFC).

Relistor Tablets Now Available for Opioid-Induced Constipation

By September 07, 2016

Previously, it had only been available as a subcutaneous injection.

New Warning, Administration Info Added to Labeling for OIC Drug Movantik

By August 24, 2016

The Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Movantik (naloxegol; AstraZeneca) tablets.

Perrigo Tentatively Approved for Generic Suprep

By August 23, 2016

Perrigo announced that it has received tentative approval from the Food and Drug Administration (FDA) for Sodium Sulfate/Potassium Sulfate/Magnesium Sulfate Oral Solution, the generic version of Braintree Laboratories' Suprep.

Constipation and CAM: Why Patients Seek Alternatives

By August 18, 2016

Patients with less severe constipation were more likely to report satisfaction with complementary and alternative treatments.