HealthDay News — The US Food and Drug Administration (FDA) has approved Xermelo (telotristat ethyl) tablets to treat adults with carcinoid syndrome diarrhea.

Xermelo, taken orally 3 times daily with food, in combination with somatostatin analog therapy, is designed to inhibit production of serotonin by carcinoid tumors, the FDA said.

The drug was evaluated in clinical studies involving 90 adults with carcinoid syndrome diarrhea, comparing results from those treated with the drug versus a placebo. 


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The agency warned that people given a higher-than-recommended dose developed severe constipation, and one required hospitalization. Any Xermelo user who develops severe constipation or abdominal pain should stop the drug and contact a doctor, the FDA said.

“Today’s approval will provide patients whose carcinoid syndrome diarrhea is not adequately controlled with another treatment option,” Julie Beitz, MD, director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, said in a statement.

Xermelo is produced by Lexicon Pharmaceuticals, based in Woodlands, Texas.

Reference

FDA Approves Xermelo for Carcinoid Syndrome Diarrhea [press release]. Silver Spring, MD: US Food and Drug Administration; February 28, 2017.

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