FDA Approves Treatment for Irritable Bowel Syndrome With Constipation

Officials with the FDA have approved plecanatide (Trulance, Synergy) for the once-daily treatment of irritable bowel syndrome with constipation (IBS-C) in adults, according to a Synergy press release. It is the second approved indication for the treatment.

Plecanatide was initially approved for the treatment of adults with chronic idiopathic constipation (CIC) and is the only prescription medication available for adults with CIC, and now IBS-C, that be taken once-daily with or without food.

The approval is based on the phase 3 IBS-C program, which included 2, 12-week trials evaluating the efficacy and safety of plecanatide in adult patients with IBS-C. More than 2100 patients received a once-daily tablet (3 mg or 6 mg doses) or a placebo. A 2-week, post treatment follow-up period was included in both trials.

In both trials, patients who received plecanatide experienced significantly reduced abdominal pain and improvement in stool frequency, stool consistency, and straining with bowel movements during the 12-week treatment period as compared to placebo.

“To date, real world patient experience has supported the clinical trial data highlighted by a post-marketing diarrhea rate of less than 0.5%, and no reports of severe diarrhea requiring hospitalization since the launch of the Trulance CIC indication,” Patrick H. Griffin, MD, Chief Medical Officer of Synergy, said in the press release.

The most common adverse event associated with use was diarrhea, with severe diarrhea reported in 1% of patients.

Reference

Synergy Pharmaceuticals Announces FDA approval of Trulance (plecanatide) for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults [news release]. https://ir.synergypharma.com/press-releases/detail/1861/synergy-pharmaceuticals-announces-fda-approval-of. Accessed January 25, 2018.