FDA Approves New Treatment for Carcinoid Syndrome Diarrhea
The FDA has approved Xermelo (telotristat ethyl) 250 mg oral tablet to be taken in combination with somatostatin analogue (SSA) therapy for the treatment of adults with carcinoid syndrome diarrhea when SSA therapy alone fails. Carcinoid syndrome is a rare disorder affecting individuals with metastatic neuroendocrine tumors.
Xermelo reduces the frequency of carcinoid syndrome diarrhea by inhibiting the production of serotonin released by carcinoid tumors.
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The FDA approved Xermelo based on evidence from a 12-week, double-blind, placebo-controlled trial that included 90 participants with well-differentiated metastatic neuroendocrine tumors and carcinoid syndrome diarrhea, ranging from 4 to 12 bowel movements a day despite SSA treatment. Participants randomly assigned to receive SSA therapy and Xermelo experienced a greater reduction in the average bowel movement frequency, with 33% experiencing an average of 2 reduced bowel movements a day compared with 4% in the placebo trial.
The most common adverse effects associated with Xermelo included nausea, headache, depression, accumulation of fluid causing swelling, flatulence, increased levels of the liver enzyme gamma-glutamyl transferase, decreased appetite, and fever.
In addition, Xermelo may cause constipation in patients, the risk of which might increase in patients who experience fewer than 4 bowel movements per day or are taking a higher than recommended dosage of Xermelo.
—Melissa Weiss
Reference:
FDA approves Xermelo for carcinoid syndrome diarrhea [press release]. FDA. February 28, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm544035.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery.