Synergy Pharmaceuticals’s plecanatide, (Trulance), a once-daily oral treatment for chronic idiopathic constipation (CIC) in adult patients, has been approved by the U.S. Food and Drug Administration. The FDA said the safety and effectiveness of the drug have not been established in patients less than 18 years of age.
Chronic idiopathic constipation refers to people experiencing persistent constipation and for whom there is no structural or biochemical explanation. According to the National Institutes of Health, an estimated 42 million people are affected by constipation.
Plecanatide goes up against Ironwood Pharmaceuticals Inc’s Linzess, which was FDA approved in 2012 to treat Irritable Bowel Syndrome with Constipation (IBS-C) and CIC in the US.
Safety and efficacy of plecanatide were established in two 12-week, placebo controlled trials including 1,775 adult participants. Participants were randomly assigned to receive a placebo or Trulance, once daily.
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. Participants receiving plecanatide were more likely to experience improvement in the frequency of complete spontaneous bowel movements than those receiving placebo, and also had improvements in stool frequency and consistency and straining.
Plecanatide is a peptide made up of 16 amino acids and, with the exception of a single amino acid substitution, it is identical to uroguanylin. Plecanatide is the first investigational drug designed to replicate the function of uroguanylin, a naturally occurring and endogenous human GI peptide which acts in a pH-dependent manner targeting GC-C receptors primarily in the proximal small intestine.
Plecanatide stimulates fluid secretion and promotes stool consistency necessary to support normal bowel function.
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Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, commented:
“No one medication works for all patients suffering from chronic gastrointestinal disorders. With the availability of new therapies, patients and their doctors can select the most appropriate treatment for their condition.”
Plecanatide should not be used in children less than six years of age due to the risk of serious dehydration. Trulance should be avoided in patients six years of age to 18 years of age. Trulance should also not be used in patients with known or suspected mechanical gastrointestinal obstruction.
Gary S. Jacob, Ph.D., Chairman and CEO of Synergy Pharmaceuticals Inc., speaking after the release of phase 3 clinical trial results in December, said:
“We are understandably very pleased with these results, and how well the data support the first pivotal phase 3 IBS-C trial which we announced recently. We have been relentless in our commitment to develop innovative treatments for the GI market. The successful phase 3 trials are a major step in our mission to better serve patients, as we believe plecanatide has the potential to be an important new treatment option for the millions of people suffering from IBS-C.”
The company plans to file a New Drug Application Supplement with Clinical Data (sNDA) for plecanatide in IBS-C in Q1 2017.