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April 12, 2017

Trulance sNDA submission for IBS-C: a step forward for Synergy Pharmaceuticals

On March 27, 2017, Synergy Pharmaceuticals submitted a supplemental New Drug Application (sNDA) for its Trulance (plecanatide) for the treatment of adults with constipation-predominant irritable bowel syndrome (IBS-C).

On March 27, 2017, Synergy Pharmaceuticals submitted a supplemental New Drug Application (sNDA) for its Trulance (plecanatide) for the treatment of adults with constipation-predominant irritable bowel syndrome (IBS-C). In January 2017, the company received approval for Trulance for the treatment of chronic idiopathic constipation (CIC). Following this, the company launched the product in the US in March 2017. GlobalData believes that the launch of Trulance for CIC and the sNDA application submission of Trulance for IBS-C are significant milestones for the US-based biopharmaceutical company in the gastrointestinal (GI) disorders space.  

Trulance is a guanylate cyclase C (GC-C) agonist and a 16-amino-acid analog of the human GI hormone, uroguanylin, which is a natural agonist for the intestinal GC-C receptor. The drug mimics uroguanylin’s functions by binding to and activating the GC-C receptor to stimulate the fluid secretion and transit required for normal digestion. It is hypothesized that Trulance exerts therapeutic effects in CIC and IBS-C patients by increasing intestinal fluid and accelerating transit.

The sNDA submission of Trulance for IBS-C was based on data from two pivotal, randomized, 12-week, double-blind, placebo-controlled, Phase III trials evaluating the efficacy and safety of Trulance for the treatment of IBS-C in 2,100 adult patients. In both trials, once-daily doses of 3mg and 6mg of Trulance met the primary endpoints. In Study 1, overall responders were 21.5% (p=0.009), 24.0% (p<0.001), and 14.2% in the 3mg, 6mg, and placebo groups, respectively. In Study 2, overall responders were 30.2% (p<0.001), 29.5% (p<0.001), and 17.8% in the 3mg, 6mg, and placebo groups, respectively. For at least 50% of the 12 treatment weeks, a patient who showed 30% or more reduction in worst abdominal pain and an increase of one or more complete spontaneous bowel movement (CSBM) from baseline in the same week was defined as an overall responder by the FDA.

In addition to Trulance, Synergy Pharmaceuticals currently has another product in development for various GI indications. The indication expansion for Trulance proposed with the sNDA submission for the treatment of IBS-C should be seen as the company paving its way to strengthening its GI portfolio, since Trulance is Synergy Pharma’s first marketed product. However, the company may need to seek out other partnership and licensing agreements in order to fully capitalize on Trulance’s commercial potential in the GI market space.

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