FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Mary L Windle, PharmD

Disclosures

January 11, 2018

In This Article

Trulance (plecanatide)

Indication:

Chronic idiopathic constipation (CIC) in adults.

Mechanism:

Guanylate cyclase C (GC-C) agonist. GC-C activation leads to increased cyclic guanosine monophosphate (cGMP), which, in turn, stimulates secretion of chloride and bicarbonate into the intestinal lumen, mainly by activation of the cystic fibrosis transmembrane conductance regulator (CFTR) ion channel, resulting in increased intestinal fluid and accelerated transit.

Dosage:

3 mg PO once daily.

Approval:

Approval was based on 2 randomized controlled trials that demonstrated significant improvements in stool frequency, stool consistency, and time of bowel movement compared with placebo.

Reference:

DeMicco M, et al. Randomized clinical trial: efficacy and safety of plecanatide in the treatment of chronic idiopathic constipation. Therap Adv Gastroenterol. 2017 Nov;10(11):837-51.

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