Trulance Approval History
Medically reviewed on 19 January, 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
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