FDA Approvals, Highlights, and Summaries: Gastroenterology

February 27, 2020

Ibsrela (tenapanor)

Tenapanor, a sodium-hydrogen exchange 3 (NHE3) inhibitor, is indicated for adults with irritable bowel syndrome with constipation. NHE3 inhibition reduces sodium absorption from the small intestine and colon, resulting in an increase in water secretion into the intestinal lumen, which accelerates intestinal transit time and results in a softer stool consistency.

Approval of tenapanor was based on 2 phase 3 trials (n=1226) that showed a statistically significant improvement in stool frequency and abdominal pain compared with placebo.

Am J Gastroenterol. 2020 Jan 13.

Additional 2019 Gastroenterology approvals

Simponi (golimumab) is indicated for moderate-to-severe ulcerative colitis in adults with an inadequate response to or who are intolerant of prior treatment or requiring continuous steroid therapy.

Stelara (ustekinumab) was approved for adults with moderately to severely active ulcerative colitis.

Zelnorm (tegaserod) was reintroduced to the US market for women younger than 65 years with irritable bowel syndrome with constipation who are at low risk of cardiovascular ischemic events.

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