FDA Approves Xermelo for Carcinoid Syndrome Diarrhea

FDA Approves Xermelo for Carcinoid Syndrome Diarrhea

WEDNESDAY, March 1, 2017 (HealthDay News) — Xermelo (telotristat ethyl) tablets have been approved by the U.S. Food and Drug Administration to treat adults with carcinoid syndrome diarrhea.

Xermelo, taken orally three 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. 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, M.D., 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.

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