January 23, 2017Regulatory
According to the National Institutes of Health, an estimated 42 million people are affected by constipation. Chronic Idiopathic Constipation (CIC) is a diagnosis given to those who experience persistent constipation and for whom there is no structural or biochemical explanation.
The FDA has approved Trulance (plecanatide) for the treatment of CIC in adult patients. 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 and 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 and 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.