The US Food and Drug Administration (FDA) has approved plecanatide 3 mg tablets (Trulance, Synergy Pharmaceuticals) for treatment of irritable bowel syndrome with constipation (IBS-C) in adults, the company has announced.
With the exception of a single amino acid substitution for greater binding affinity, plecanatide is structurally identical to human uroguanylin, a naturally occurring human gastrointestinal (GI) peptide that plays an important role in supporting normal bowel function. It is taken once daily by mouth, with or without food.
"Approximately 1 in 20 Americans are living with IBS-C, many of whom are not satisfied with currently available treatment options," said William D. Chey, MD, director of the GI Physiology Laboratory and codirector of the Michigan Bowel Control Program at the University of Michigan, Ann Arbor, in a company news release.
"With this second indication for Trulance, patients and physicians will have a much-needed, new treatment option with an established safety profile that can effectively address abdominal pain and constipation experienced by patients with IBS-C," Dr Chey said.
Two phase 3 randomized, 12-week, double-blind, placebo-controlled trials evaluated the efficacy and safety of plecanatide in more than 2100 adults with IBS-C. Patients received plecanatide 3 mg or 6 mg or placebo once daily. Both trials included a 2-week, pretreatment baseline period, a 12-week treatment period, and a 2-week, posttreatment follow-up period.
The primary endpoint for both trials was the percentage of patients who experienced an overall response during the 12-week treatment period. The FDA defined such patients as those who had both a ≥30% reduction in worst abdominal pain and an increase of ≥1 complete spontaneous bowel movements from baseline in the same week for at least 50% of the 12 treatment weeks.
In both studies, plecanatide met the primary endpoint as compared with placebo. The responder rate (plecanatide vs placebo) was 30.2% vs 17.8% (P < .001) in one study and 21.5% vs 14.2% P = .009) in the other study.
In both studies, patients who took plecanatide experienced significant reductions in abdominal pain, as well as improvements in stool frequency, stool consistency, and straining with bowel movements, during the 12-week treatment period as compared to the patients who received placebo.
Diarrhea was the most common adverse event with plecanatide, reported in 4.3% of study patients; severe diarrhea was reported in 1%. Discontinuation rates were low among patients treated with plecanatide and those who received placebo (2.5% vs 0.4%).
Plecanatide is contraindicated in patients younger than 6 years and should be avoided in patients younger than 18 years. Full prescribing information is available online.
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Cite this: Plecanatide (Trulance) Gets FDA Nod for IBS With Constipation in Adults - Medscape - Jan 26, 2018.