In January 2018, plecanatide (Trulance®), developed by Synergy Pharmaceuticals, received approval for the treatment of adult patients with irritable bowel syndrome with constipation (IBS-C).[1] This is the second indication for the agent and comes a year after its first global approval in the US for the treatment of adults with chronic idiopathic constipation (CIC).[2]

Plecanatide is an oral, once-daily medication that can be taken at any time of the day, with or without food. The agent is designed, with the exception of a single amino acid substitution to provide greater binding affinity, to be structurally identical to human uroguanylin; it is thought to replicate the pH-sensitive activity of natural uroguanylin. [1]

It is hoped that this convenient dosing regimen will provide much needed aid to the large number of patients living with IBS-C that have been described by William D. Chey, M.D., Professor of Medicine, Director of the GI Physiology Laboratory, and Co-Director of the Michigan Bowel Control Program at the University of Michigan as “not satisfied with currently available treatment options.” [1]

“With this second indication for TRULANCE,” he said, “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.” [1]

The approval for plecanatide in IBS-C was supported by data from two randomised, 12-week, double-blind, phase III trials.[3] [4]

The safety of plecanatide in patients under 18 years has not been established, and it’s use in patients less than 6 years is contraindicated based on a risk of serious dehydration, concluded from observations made in preclinical trails in rodents.[1]

The recent first global approval[2] of plecanatide has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[5], based on the development milestones tracked in AdisInsight.[6]

 

Image credit: Tim Gouw

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