The U.S. FDA approved Synergy Pharmaceuticals Inc.'s once-daily 3 milligram Trulance for adults with chronic idiopathic constipation.
The orally administered drug showed improved stool frequency and consistency in two studies compared to placebo. It is the first drug designed to replicate the function of uroguanylin, a gastrointestinal peptide that is thought to stimulate fluid secretion that results in a stool consistency associated with more regular bowel function, the company said in a news release.
Trulance will be available in the U.S. in the first quarter.
The company also said it completed two phase 3 trials for the drug to treat irritable bowel syndrome with constipation and plans to file a new drug application supplement later this quarter.