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Conclusion
Plecanatide is approved for the treatment of CIC in adults.
In placebo-controlled studies, plecanatide improved the frequency of both SBMs and CSBMs. Head-to-head comparison studies with linaclotide have not been conducted.
Although linaclotide is approved for both CIC and IBS-C,
plecanatide is only approved for CIC. Outcome data to evaluate the impact on health care costs (eg, changes in frequency of clinic visits, frequency of acute exacerbations)
are not available.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with
respect to the research, authorship, and/or publication of this
article.

Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.

References
1. Beitz J. NDA approval letter: Trulance (plecanatide NDA
208745). Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208745Orig1
s000ltr.pdf. Published January 19, 2017. Accessed January
23, 2017.
2. Trulance (plecanatide) [prescribing information]. New York,
NY: Synergy Pharmaceuticals; 2017.
3. Plecanatide. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/
results?term=plecanatide&Search=Search. Accessed January
21, 2017.
4. Synergy Pharmaceuticals. The plecanatide irritable bowel
syndrome with constipation study (IBS-C) (CIBS). NLM
Identifier: NCT01722318. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01722318?term=NCT01722318
&rank=1. Updated January 13, 2015. Accessed January 21,
2017.
5. Synergy Pharmaceuticals. Synergy Pharmaceuticals announces
acceptance of new drug application for plecanatide, a novel
uroguanylin analog, in chronic idiopathic constipation [news
release]. http://ir.synergypharma.com/press-releases/detail/1809/
synergy-pharmaceuticals-announces-acceptance-of-new-drug.
Published April 19, 2016. Accessed January 21, 2017.
6. Ford AC, Moayyedi P, Lacy BE, et al; Task Force on the
Management of Functional Bowel Disorders. American
College of Gastroenterology monograph on the management
of irritable bowel syndrome and chronic idiopathic constipation. Am J Gastroenterol. 2014;109(suppl 1):S2-S26.
7. Paquette IM, Varma M, Ternent C, et al. The American Society
of Colon and Rectal Surgeons' clinical practice guideline for
the evaluation and management of constipation. Dis Colon
Rectum. 2016;59(6):479-492.
8. Linzess (linaclotide) [prescribing information]. Cambridge,
MA: Forest Pharmaceuticals; 2016.
9. Camilleri M. Pharmacology of the new treatments for lower
gastrointestinal motility disorders and irritable bowel syndrome. Clin Pharmacol Ther. 2012;91(1):44-59.

Hospital Pharmacy 52(6)
10. Jadallah KA, Kullab SM, Sanders DS. Constipationpredominant irritable bowel syndrome: a review of current and emerging drug therapies. World J Gastroenterol.
2014;20(27):8898-8909.
11. Pitari GM. Pharmacology and clinical potential of guanylyl
cyclase C agonists in the treatment of ulcerative colitis. Drug
Des Devel Ther. 2013;7:351-360.
12. Busby RW, Ortiz S. Clarification of linaclotide pharmacology
presented in a recent clinical study of plecanatide. Dig Dis Sci.
2014;59(5):1066-1067.
13. Jarmuż A, Zielkińska M, Storr M, Fichna J. Emerging treatments in neurogastroenterology: perspectives of guanylyl
cyclase C agonists use in functional gastrointestinal disorders
and inflammatory bowel diseases. Neurogastroenterol Motil.
2015;27(8):1057-1068.
14. Shailubhai K, Comiskey S, Foss JA, et al. Plecanatide, an oral
guanylate cyclase C agonist acting locally in the gastrointestinal tract, is safe and well-tolerated in single doses. Dig Dis Sci.
2013;58(9):2580-2586.
15. Shailubhai K, Palejwala V, Arjunan KP, et al. Plecanatide
and dolcanatide, novel guanylate cyclase-C agonists, ameliorate gastrointestinal inflammation in experimental models of murine colitis. World J Gastrointest Pharmacol Ther.
2015;6(4):213-222.
16. Shailubhai K, Barrow L, Talluto C, et al. Plecanatide, a guanylate cyclase-C agonist, improves bowel habits and symptoms
associated with chronic constipation in a phase IIa clinical
study [poster P1174]. Poster presented at: 2011 American
College of Gastroenterology Annual Scientific Meeting;
October 28-November 8, 2011; Washington, DC. http://content.stockpr.com/synergypharma/db/Posters/93/poster_file/
Synergy_Poster_P1174.pdf. Accessed May 16, 2016.
17. Miner PB, Surowitz R, Fogel R, et al. Plecanatide, a novel guanylate cyclase-C (GC-C) receptor agonist, is efficacious and
safe in patients with chronic idiopathic constipation (CIC):
results from a 951 patient, 12 week, multi-center trial [abstract
925g]. Gastroenterology. 2013;144(5)(suppl 1):S163.
18. Synergy Pharmaceuticals. The plecanatide chronic idiopathic
constipation (CIC) study. NLM Identifier: NCT01429987.
ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01
429987?term=plecanatide&rank=3. Updated April 26, 2016.
Accessed January 21, 2017.
19. Miner PB, Prieto B, De La Portilla M, et al. A phase III study
of the efficacy and safety of plecanatide in the treatment of
chronic idiopathic constipation (CIC) (study-00) [abstract
Sa1440]. Gastroenterology. 2016;150(4)(suppl 1):S316.
20. Synergy Pharmaceuticals. 12-week study of plecanatide
for CIC (the CIC3 study). NLM Identifier: NCT01982240.
ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/record/
NCT01982240?term=plecanatide&rank=1. Updated April 26,
2016. Accessed January 21, 2017.
21. Miner PB, Lentz JD, Berenguer R, et al. Efficacy and safety of plecanatide in the treatment of chronic idiopathic constipation (CIC):
results from a multicenter phase III study (study-03) [abstract
Su1214]. Gastroenterology. 2016;150(4)(suppl 1):s497-s498.
22. Synergy Pharmaceuticals. 12-week study of plecanatide for CIC
(the National CIC3 Study). NLM Identifier: NCT02122471.
ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02
122471?term=plecanatide&rank=2. Updated April 26, 2016.
Accessed January 21, 2017.
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