TRULANCE™ (plecanatide) receives US FDA approval for the treatment of adults with chronic idiopathic constipation

Synergy Pharmaceuticals Inc. —


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3 mg taken orally, once daily

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Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) announced today that the US Food and Drug Administration (FDA) has approved TRULANCE (plecanatide) for the treatment of 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. CIC 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. CIC affects approximately 33 million Americans and an estimated 14% of the global population. 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 two randomized, 12-week, double-blind, placebo-controlled studies of TRULANCE. Over 12 weeks, patients treated with TRULANCE achieved a significantly greater efficacy responder rate — the primary endpoint defined by the FDA for regulatory approval in CIC — in both studies compared to placebo (Study 1: 21% vs 10%; Study 2: 21% vs 13%, P<0.005 for both studies). Efficacy responders were defined as patients who had at least three complete spontaneous bowel movements (CSBMs) in a given week and an increase of at least one CSBM over baseline in the same week for at least nine weeks out of the 12-week period, including at least three of the last four 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 (as measured by the Bristol Stool Form Scale) and straining with bowel movements. "The impact of chronic constipation on the lives of affected patients is often underestimated,” said William D. Chey, MD, Professor of Medicine, Director of the GI Physiology Laboratory, and Co-Director of the Michigan Bowel Control Program at the University of Michigan. “TRULANCE presents an exciting new treatment option for patients with chronic constipation. Its efficacy and safety profile, plus its negligible systemic absorption, are attractive attributes that make it a welcome addition to our treatment options.” 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). The approved dosing regimen for TRULANCE is 3 mg taken orally, once daily, with or without food at any time of the day. TRULANCE can be swallowed whole or crushed in applesauce for those who are unable to swallow medication. TRULANCE will be available in the US later this quarter. 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.

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