FDA Action
The FDA has approved a second cyclase-C agonist for the treatment of chronic idiopathic constipation. Plecanatide is a once-a-day tablet that stimulates fluid movement in the gut and facilitates defecation. It follows linaclotide (Linzess), which was approved in 2012 for the same indication, although linaclotide also was approved for irritable bowel syndrome with constipation. Plecanatide was approved on the strength of two 12-week, placebo-controlled trials in 1,775 adults suffering from chronic idiopathic constipation, defined by less than three defecations per week for at least the previous three months, as well as other constipation-related symptoms. Plecanatide resulted in improved frequency of complete spontaneous bowel movements compared to placebo as well as improvements in stool frequency, consistency, and straining. The most common side effect was diarrhea. Plecanatide is marketed as Trulance.
The FDA has approved a second cyclase-C agonist for the treatment of chronic idiopathic constipation.
Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.