Constipation And Bowel Cleansers
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.
There was no significant difference between the two therapies in odds ratios for efficacy, diarrhea, or diarrhea-related study withdrawals.
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.
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.
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.
Symproic, initially approved as a CII controlled substance in March 2017, was officially descheduled by the Drug Enforcement Agency (DEA) in September 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.
The prescribing information has been updated to provide clarification of the opioid-induced constipation (OIC) indication.
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.
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).
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).
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.
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.
Trulance (plecanatide; Synergy) has been approved by the Food and Drug Administration (FDA) for the treatment of chronic idiopathic constipation (CIC) in adult patients.
Synergy has announced results from the first two pivotal Phase 3 trials evaluating plecanatide in patients with irritable bowel syndrome with constipation (IBS-C).
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 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.
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).
The Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Movantik (naloxegol; AstraZeneca) tablets.
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.
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.