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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 U.S. 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. Indications and Usage TRULANCE is a guanylate cyclase-C (GC-C) agonist indicated in adults for the treatment of chronic idiopathic constipation (CIC). IMPORTANT SAFETY INFORMATION WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS Trulance is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile mice administration of a single oral dose of plecanatide caused deaths due to dehydration. Use of Trulance should be avoided in patients 6 years to less than 18 years of age.
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For the original version including any supplementary images or video, visit http://www.marketwatch.com/story/synergy-pharmaceuticals-trulancetmplecanatide-receives-us-fda-approval-for-the-treatment-of-adults-with-chronic-idiopathic-constipation-2017-01-19-19159270