January 20, 2017
The US Food and Drug Administration has approved Trulance (plecanatide; Synergy Pharma) for the treatment of chronic idiopathic constipation in adult patients.
Class I Recall of Constipation Med
Lubiprostone improves bowel movements in patients with diabetes
CIC is a diagnosis given to patients who experience persistent constipation, but with no structural or biochemical explanation. The National Institutes of Health estimates that more than 42 million people are affected by constipation. Plecanatide works locally in the upper gastrointestinal tract to stimulate secretion of intestinal fluid and support regular bowl function.
The decision to approve the drug for CIC was based on two, 12-week, placebo-controlled trials including 1775 adult patients who were randomly assigned to receive either a placebo or plecanatide. Participants in the trials were required to have been diagnosed with constipation at least six months prior to the study onset and to have less than three defecations per week in the previous three months, as well as other symptoms associated with constipation.
Results of the trials demonstrated that those who received plecanatide were more likely to experience improvement in complete spontaneous bowel movements than those who received placebo. They also experienced improvements in stool frequency, consistency, and straining.
However, the safety and efficacy of plecanatide has not been established in those under 18 years and should be avoided in this demographic. It should not be used in children less than 6 years due to risk of serious dehydration. The most common adverse event associated with plecanatide treatment was diarrhea. Severe diarrhea may also occur.
“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 Inc. “I am confident that we truly have the right team with the right strategic vision and the right launch plan to successfully bring TRULANCE into this large but underserved market.”
Trulance is manufactured by New York, New York-based Synergy Pharmaceuticals Inc. It should be taken orally, once daily, with or without food at any time of the day.--Sean McGuire
Synergy Pharma (SGYP) Trulance (Plecanatide) Approved by FDA. StreetInsider Website. bit.ly/2jHb7A1. Published January 19, 2017. Accessed January 20, 2017.
Synergy Pharmaceuticals’ TRULANCE™ (Plecanatide) Receives U.S. FDA Approval for the Treatment of Adults with Chronic Idiopathic Constipation. Yahoo Finance Website. yhoo.it/2jUv8QB. Published January 19, 2017. Accessed January 20, 2017.