FDA Approves Carcinoid Syndrome Diarrhea Treatment

The FDA has approved a drug for the treatment of carcinoid syndrome diarrhea. Xermelo (telotristat ethyl) tablets, in combination with somatostatin analog (SSA) therapy, are indicated to treat adults with carcinoid syndrome diarrhea that SSA therapy alone has not adequately controlled.

Xermelo tablets work by inhibiting the production of serotonin by carcinoid tumors and reducing the frequency of carcinoid syndrome diarrhea.

Lexicon Pharmaceuticals submitted the application for the approval based on a 12-week clinical trial that established the safety and efficacy of the treatment in patients with well-differentiated metastatic neuroendocrine tumors and carcinoid syndrome diarrhea. Patients who added Xermelo to their SSA treatment experienced a greater reduction in average bowel movement frequency than patients on SSA and a placebo.

The most common adverse events associated with Xermelo include nausea, headache, increased levels of the liver enzyme gamma-glutamyl transferase, depression, accumulation of fluid causing swelling (peripheral edema), flatulence, decrease appetite, and fever. Xermelo may also cause constipation and risk of constipation may be higher in patients whose bowel movement frequency is less than 4 bowel movements per day.

Reference

FDA approves Xermelo for carcinoid syndrome diarrhea [news release]. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm544035.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed Mar. 1, 2017.