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Trulance Approval History

Reviewed on Jan 19, 2017 by J.Stewart BPharm
  • FDA approved: Yes (First approved January 19th, 2017)
  • Brand name: Trulance
  • Generic name: plecanatide
  • Dosage form: Tablets
  • Company: Synergy Pharmaceuticals Inc.
  • Treatment for: Constipation, Chronic

Trulance (plecanatide) is a guanylate cyclase-C agonist for the treatment of chronic idiopathic constipation in adults.

Trulance works by stimulating intestinal fluid secretions in the gastrointestinal tract to support regular bowel function.

FDA approval of Trulance was based on the results of two randomized, 12-week placebo-controlled clinical studies involving 1,775 adult patients with constipation. Patients who received Trulance in both studies showed improvement in the frequency of complete spontaneous bowel movements, stool frequency and consistency, and straining compared to those who received a placebo.

Trulance is an oral tablet taken once daily with or without food. Trulance comes with a warning advising the risk of serious dehydration in pediatric patients and should not be used in children less than six years of age, and should be avoided in patients six years to 18 years of age. The most common side effect is diarrhea, which may be severe.

Development History and FDA Approval Process for Trulance

DateArticle
Jan 19, 2017Approval FDA Approves Trulance (plecanatide) for Chronic Idiopathic Constipation
Dec  9, 2016Synergy Pharmaceuticals Announces Positive Results in First Phase 3 Trial of Plecanatide in Patients with Irritable Bowel Syndrome with Constipation (IBS-C)
Jul 15, 2016Synergy Pharmaceuticals Provides Update on Ongoing FDA Review of Plecanatide CIC NDA and IBS-C Clinical Development Program
Apr 19, 2016Synergy Pharmaceuticals Announces Acceptance of NDA for Plecanatide, a Novel Uroguanylin Analog, in Chronic Idiopathic Constipation
Jan 29, 2016Synergy Pharmaceuticals Files NDA for Plecanatide in Chronic Idiopathic Constipation
Jun 23, 2015Synergy Pharmaceuticals Initiates Second Phase 3 Clinical Trial of Plecanatide in Patients with IBS with Constipation
Oct 21, 2014Synergy Pharmaceuticals Presents Positive Phase 2b Study Results for Plecanatide in IBS with Constipation
May 21, 2013Synergy Pharmaceuticals Presents Plecanatide Results From a Large Multicenter Clinical Study at Late-Breaking Abstract Session During Digestive Disease Week 2013
Jan  2, 2013Synergy Announces Positive Results From Plecanatide Phase IIb/III Trial in Patients With Chronic Idiopathic Constipation
Oct  6, 2010Synergy Pharmaceuticals Announces Positive Phase IIa Results with Plecanatide to Treat Chronic Constipation

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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