FDA OKs Plecanatide for Chronic Idiopathic Constipation

Alicia Ault

January 19, 2017

The US Food and Drug Administration (FDA) has approved plecanatide for chronic idiopathic constipation (CIC) in adults.

Plecanatide (Trulance, Synergy Pharmaceuticals), a once-daily oral medication, works locally in the upper gastrointestinal tract to stimulate secretion of intestinal fluid and support regular bowel function, according to the FDA.

"No one medication works for all patients suffering from chronic gastrointestinal disorders," said Julie Beitz, MD, director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research, in a statement. "With the availability of new therapies, patients and their doctors can select the most appropriate treatment for their condition."

Forty-two million Americans are affected by constipation, according to the National Institutes of Health. CIC has no known cause.

In two 12-week, randomized, placebo-controlled trials including 1775 adults, plecanatide recipients were more likely to experience improvement in the frequency of complete spontaneous bowel movements than those receiving placebo. They also had improvements in stool frequency and consistency and straining.

Study participants were required to have been diagnosed with constipation at least 6 months prior to the study onset and to have fewer than three defecations per week in the previous 3 months.

The safety and effectiveness of plecanatide have not been established in patients younger than 18 years. The FDA said the drug should not be used in children younger than 6 years because of the risk for serious dehydration, and that it should be avoided in children aged 6 to 18 years. Plecanatide is also contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.

The most common and serious side effect was diarrhea, which can be severe.

Plecanatide joins two other medications on the market for CIC: lubiprostone (Amitiza, Sucampo), which was approved by the FDA in 2006, and linaclotide (Linzess, Forest Laboratories and Ironwood Pharmaceuticals), which was approved in 2012.

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