Constipation And Bowel Cleansers

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.

Split- vs. Single-Dose Bowel Preps: Impact on BM Intensity, Duration, and Polyp Detection

By July 27, 2016

Split-dose (SPD) bowel preparation regimen led to reduced intensity and duration of bowel movements as well as less patient inconvenience, improved bowel preparation, and increased sessile-serrated poly detection rates, compared with a single-dose (SID) preparation, study authors reported in the American Journal of Gastroenterology.

FDA Approves Oral Formulation of Relistor for OIC

By July 20, 2016

Valeant and Progenics announced that the Food and Drug Administration (FDA) has approved Relistor (methylnaltrexone bromide) tablets for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain.

FDA: <em>B. Cepacia</em> Contamination Confirmed in Liquid Stool Softeners

By July 18, 2016

At this time, these products should not be used for any medical purposes, says the FDA.

Lower Dosage of Chronic Idiopathic Constipation Drug Under Review

By June 09, 2016

The Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for the 72mcg dose of linaclotide (Ironwood and Allergan) for the treatment of adults with chronic idiopathic constipation (CIC).

Clear Liquids Only Before Colonoscopy? Study Says Maybe Not

May 25, 2016

Low-residue diet leads to improved bowel prep, more rested patients

Positive Phase 3 Results for Chronic Idiopathic Constipation Drug

By May 23, 2016

Synergy announced additional clinical data from two Phase 3 trials, Study-00 and Study-03, evaluating the efficacy and safety of plecanatide for the treatment of chronic idiopathic constipation (CIC). Study findings were presented at Digestive Disease Week (DDW) in San Diego.

Novel Chronic Idiopathic Constipation Drug Under FDA Review

By April 19, 2016

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for plecanatide (Synergy) for the treatment of chronic idiopathic constipation (CIC).

Naldemedine NDA Submitted for Opioid-Induced Constipation

By March 30, 2016

Shionogi announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for naldemedine 0.2mg once daily tablet for the treatment of opioid-induced constipation (OIC).