Synergy Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration approved the sale of Trulance. The drug is used to treat chronic constipation in adults. Trulance is designed to replicate the function of a naturally occurring human gastrointestinal peptide uroguanylin that stimulate fluid secretion which serves to make stool consistency associated with regular bowel function.
Gary S. Jacob, PhD., Chairman and CEO of Synergy Pharmaceuticals Inc stated that they are thrilled with the approval of Trulance by the FDA because it will provide much needed additional treatment options to help adults suffering from chronic idiopathic constipation. CIC is a complex gastrointestinal disorder defined by symptoms including fewer than three bowel movements a week, incomplete bowel movement and hard to pass bowel movement.
Chronic constipation affects roughly 33 million Americans and around 14 percent of the world population. According to William D. Chey, M.D., professor of medicine, director of the G.I. Physiology Laboratory and co-director of Michigan Bowel Control Program at the University of Michigan, the impact of chronic constipation on the lives of affected people are often underestimated. He said that Trulance presents a new treatment option for these patients. According to Chey, the safety profile, its negligible systemic absorption and efficacy are very good attributes and makes a welcome addition to their treatment options as reported in Yahoo Finance.
Trulance should not be administered to children less than six years of age because it carries the risk of serious dehydration. The drug is to be avoided in patients who are six years to 18 years of age. Trulance's safety and effectiveness has not been established in patients less than 18 years of age. The drug is also not be used in patients with known or suspected mechanical obstruction of the gastrointestinal tract. The most common and serious side effects of Trulance is diarrhea. If severe diarrhea occurs, Trulance use should be stopped and the patients are to contact their health care provider as reported in an article by the U.S. Food and Drug Administration.
