Xermelo Approved for Tumor-Related Diarrhea
WEDNESDAY, March 1, 2017 -- Xermelo (telotristat ethyl) tablets have been approved by the U.S. Food and Drug Administration to treat adults with carcinoid syndrome diarrhea, one of a collection of symptoms related to rare carcinoid tumors.
Most of these slow-growing tumors are found in the gastrointestinal tract, the agency said in a news release. Carcinoid syndrome occurs in fewer than 10 percent of people with carcinoid tumors, commonly after the tumor has spread to the liver. The tumor releases an excess amount of the hormone serotonin, leading to diarrhea.
Complications can include weight loss, malnutrition, dehydration and an imbalance of electrolytes.
Xermelo, taken three times daily with food, 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.
Xermelo is produced by Lexicon Pharmaceuticals, based in Woodlands, Texas.
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Posted: March 2017