12/10/22, 7:51 PM
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`FDA approves Trulance for Chronic Idiopathic Constipation | FDA
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`FDA NEWS RELEASE
`FDA approves Trulance for Chronic Idiopathic Constipation
`
`For Immediate Release:
`January 19, 2017
`
`The U.S. Food and Drug Administration today approved Trulance (plecanatide) for the treatment of Chronic
`Idiopathic Constipation (CIC) in adult patients.
`
`“No one medication works for all patients suffering from chronic gastrointestinal disorders,” said Julie Beitz,
`M.D., director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research.
`“With the availability of new therapies, patients and their doctors can select the most appropriate treatment
`for their condition.”
`
`According to the National Institutes of Health, an estimated 42 million people are affected by constipation.
`Chronic idiopathic constipation is a diagnosis given to those who experience persistent constipation and for
`whom there is no structural or biochemical explanation.
`
`Trulance, taken orally once daily, works locally in the upper GI tract to stimulate secretion of intestinal fluid
`and support regular bowel function.
`
`The safety and efficacy of Trulance were established in two 12-week, placebo-controlled trials including 1,775
`adult participants. Participants were randomly assigned to receive a placebo or Trulance, once daily.
`Participants in the trials were required to have been diagnosed with constipation at least six months prior to
`the study onset and to have less than three defecations per week in the previous three months, as well as
`other symptoms associated with constipation. 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.
`
`Trulance should not be used in children less than six years of age due to the risk of serious dehydration.
`Trulance should be avoided in patients six years of age to 18 years of age. The safety and effectiveness of
`Trulance have not been established in patients less than 18 years of age. Trulance should not be used in
`patients with known or suspected mechanical gastrointestinal obstruction.
`
`The most common and serious side effects of Trulance was diarrhea. Patients may experience severe
`diarrhea. If severe diarrhea occurs, patients should stop taking Trulance and contact their health care
`provider.
`
`Trulance is manufactured by New York, New York-based Synergy Pharmaceuticals Inc.
`
`The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by
`assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological
`products for human use, and medical devices. The agency also is responsible for the safety and security of our
`nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for
`regulating tobacco products.
`
`https://www.fda.gov/news-events/press-announcements/fda-approves-trulance-chronic-idiopathic-constipation
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`Bausch Health Ireland Exhibit 2031, Page 1 of 2
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`12/10/22, 7:51 PM
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`Related Information
`
`FDA approves Trulance for Chronic Idiopathic Constipation | FDA
`
`FDA Approved Drugs: Questions and Answers (/drugs/information-consumers-drugs/approved-drugs-
`questions-and-answers)
`
`NIH: Constipation (https://www.niddk.nih.gov/health-information/digestive-diseases/constipation)
`
`###
`
`Inquiries
`Media:
` Andrea Fischer (mailto:andrea.scher@fda.hhs.gov)
` 301-796-0393
`
`Consumer:
` 888-INFO-FDA
`
` More Press Announcements (/news-events/newsroom/press-announcements)
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`https://www.fda.gov/news-events/press-announcements/fda-approves-trulance-chronic-idiopathic-constipation
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`2/2
`
`Bausch Health Ireland Exhibit 2031, Page 2 of 2
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
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