On August, 30th 2012 US FDA approved linaclotide for irritable Bowel Disease with constipation in adults.
According to the National Institutes of Health, an estimated 63 million people are affected by chronic constipation. Chronic idiopathic constipation is a diagnosis given to those who experience persistent constipation and do not respond to standard treatment. Additionally, an estimated 15.3 million people are affected by IBS. IBS-C is a subtype characterized mainly by abdominal pain and by hard or lumpy stools at least 25 percent of the time and loose or watery stools less than 25 percent of the time.
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| Constipation (Photo credit: The Djudju Beast) |
It is a guanylate cyclase type-C (GC-C) agonist. Linaclotide binds to the
GC-C receptor locally in the intestine, with no measurable blood plasma
concentrations, resulting in an increase in both intracellular and
extracellular concentrations of cyclic guanosine monophosphate (cGMP), according to the manufacturer. Elevations in intracellular cGMP are believed to
stimulate secretion of intestinal fluid and accelerate gastrointestinal
transit, resulting in increased frequency of bowel movements.
Elevations
in extracellular cGMP are believed to decrease activity of pain-sensing
nerves, which is thought to be responsible for a reduction in
intestinal pain, according to nonclinical models.
Linzess (linaclotide) is a capsule taken once daily on an empty stomach, at least 30 minutes before the first meal of the day. Linzess helps relieve constipation by helping bowel movements occur more often. In IBS-C, it may also help ease abdominal pain.
The safety and effectiveness of Linzess for the management of chronic idiopathic constipation also were established in two, double-blind studies. A total of 1,272 patients were randomly assigned to take Linzess at doses of 145 mcg or 290 mcg or a placebo for 12 weeks. Results from these studies showed patients taking Linzess experienced more complete spontaneous bowel movements than those taking the placebo. The 290 mcg dose is not approved for chronic constipation because studies indicated it was no more effective than the 145 mcg dose.
Linzess is approved with a Boxed Warning to alert patients and health care professionals that the drug should not be used in patients 17 years of age and younger. The most common side effect reported in during the clinical studies was diarrhea.
Access the original article here.
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