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FDA Approves Trulance for Chronic Idiopathic Constipation
FDA news release; 2017 Jan 19
The FDA has approved Trulance (plecanatide) for the treatment of chronic idiopathic constipation.
Indications: Trulance (plecanatide) is approved for the treatment of chronic idiopathic constipation (CIC) in adult patients. It should not be used in children aged < 6 years or in patients aged 6 to 18.
Dosage/administration: Trulance is taken orally once daily and works locally in the upper GI tract to stimulate secretion of intestinal fluid and support regular bowel function.
Safety/efficacy: The safety and efficacy of Trulance were established in two, 12-week, placebo-controlled trials including 1,775 adult participants. Participants receiving Trulance were more likely to experience improvement in the frequency of complete spontaneous bowel movements than those receiving placebo, and also had improvements in stool frequency and consistency and straining.
Adverse reactions: The most common and serious side effects of Trulance was diarrhea.
US Food and Drug Administration. FDA approves Trulance for chronic idiopathic constipation. FDA Web site. January 19, 2017. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm537725.htm. Accessed January 22, 2017.
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