Constipation drug wins approval
FDA approved plecanatide (Trulance, Synergy Pharmaceuticals) for adults with chronic idiopathic constipation (CIC).
Trulance is the first drug designed to replicate the function of uroguanylin, a naturally occurring and endogenous human gastrointestinal (GI) peptide that is thought to stimulate fluid secretion which results in a stool consistency associated with more regular bowel function.
Synergy expects Trulance to be available later this quarter. Trulance, taken orally once daily, works locally in the upper GI tract to stimulate secretion of intestinal fluid and support regular bowel function.
“We are thrilled with the approval of Trulance because it provides an additional, much-needed, new treatment option to help adults with chronic idiopathic constipation and their healthcare providers manage this condition,” said Gary S. Jacob, PhD, chairman and CEO of Synergy Pharmaceuticals.
CIC, which affects around 33 million Americans, is a complex, functional GI disorder defined by symptoms including fewer than three bowel movements a week and hard-to-pass or incomplete bowel movements, for which there is no identifiable cause.
“No one medication works for all patients suffering from chronic gastrointestinal disorders,” said Julie Beitz, MD, director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research. “With the availability of new therapies, patients and their doctors can select the most appropriate treatment for their condition.”
The efficacy and safety of Trulance was evaluated in the largest phase 3 CIC clinical trials to date, which included more than 2,600 patients in 2 randomized, 12-week, double-blind, placebo-controlled studies.
Over 12 weeks, patients treated with Trulance achieved a significantly greater efficacy responder rate in both studies compared to placebo (Study 1: 21% vs. 10%; Study 2: 21% vs. 13%). Efficacy responders were defined as patients who had at least 3 complete spontaneous bowel movements (CSBMs) in a given week and an increase of at least 1 CSBM over baseline in the same week for at least 9 weeks out of the 12-week period, including at least 3 of the last 4 weeks.
Over 12 weeks, patients who received Trulance in both studies also had improvements as compared to placebo in stool frequency (as measured by the number of spontaneous bowel movements per week), stool consistency and straining with bowel movements.
In an integrated analysis of both studies, diarrhea was the most common adverse reaction, reported in 5% of patients treated with Trulance compared to 1% of patients treated with placebo. Overall discontinuation rates were low among patients treated with Trulance and placebo (4% vs. 2%, respectively) and the most common adverse reaction leading to discontinuation was diarrhea (2% for Trulance compared to 0.5% in placebo).
Synergy has also completed two phase 3 clinical trials for Trulance in irritable bowel syndrome with constipation (IBS-C) and plans to file a New Drug Application Supplement with Clinical Data (sNDA) later this quarter with an expected 10-month review period from submission.