The U.S. Food and Drug Administration announced the approval of Trulance® (plecanatide), an oral treatment for chronic idiopathic constipation (CIC). The one-a-day tablet works in the upper gastrointestinal tract to stimulate intestinal fluid secretion and support regular bowel movement.
About 42 million individuals suffer from constipation. Chronic, long-term constipation leads to harmful effects like hemorrhoids and anal fissures and some research suggests an association between chronic constipation and cardiovascular disease. Short-term effects of constipation include abdominal pain, bloating, and small amounts of blood or whitish mucus found in the stool.
Certain conditions like irritable bowel syndrome with constipation (IBS-C), use of antacid drugs containing calcium or aluminum, narcotics, dietary changes, onset of neurological disorders like Parkinson’s, and heavy intake of dairy products are all associated with constipation. Constipation may also be caused by not getting enough water or fiber in one’s diet.
For the FDA approval, Trulance met both safety and effectiveness endpoints in two clinical studies published in December in irritable bowel syndrome patients who have constipation (IBS-C). The two trials included 1,775 adults and ran for 12 weeks.