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Medicines licensing

New drug for chronic constipation approved by US Food and Drug Administration

The US Food and Drug Administration has approved plecanatide (Trulance; Synergy Pharmaceuticals) as another option for the treatment of chronic idiopathic constipation (CIC) in adults.

Plecanatide, which should be taken daily, supports regular bowel function by stimulating the upper gastrointestinal tract to secrete intestinal fluid.

In two 12-week trials, patients receiving the drug once daily were more likely to experience improvement in the frequency of complete spontaneous bowel movements than those receiving placebo. They also reported improvements in stool frequency and consistency and straining. The two trials included 1,775 adults who had been diagnosed with constipation at least six months previously and had fewer than three defecations per week in the previous three months, as well as other symptoms associated with constipation. The most common and serious side effect was diarrhoea.

Plecanatide should not be used in patients with known or suspected mechanical gastrointestinal obstruction, and patients should stop taking the drug if they experience severe diarrhoea.

Children under 6 should not be given the drug owing to the risk of serious dehydration, and it should be avoided in patients aged 6 to 18 years because its safety and effectiveness have not been established in this age group.

Julie Beitz, director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, says: “No one medication works for all patients suffering from chronic gastrointestinal disorders. With the availability of new therapies, patients and their doctors can select the most appropriate treatment for their condition.”

 

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20202227

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