FDA Approves Xermelo for Carcinoid Syndrome Diarrhea

Share this content:
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.

More Information

Share this content:

is free, fast, and customized just for you!




Already a member?

Sign In Now »

Trending Activities

All Professions

Drug Lookup

Browse drugs by: BrandGenericDisease

More in Home

Plan to Relax Coal-Fired Power Plant Rules Could Up Mortality

Plan to Relax Coal-Fired Power Plant Rules Could ...

EPA predicts between 470 and 1,400 premature deaths a year by 2030

FDA Extends EpiPen Expiration Dates to Tackle Shortage

FDA Extends EpiPen Expiration Dates to Tackle Shortage

Shortages due to factors such as supply disruptions and manufacturer issues

USPSTF Updates Guidance for Cervical Cancer Screening

USPSTF Updates Guidance for Cervical Cancer Screening

Cytology recommended every three years from age 21; different screening options from age 30 to 65

is free, fast, and customized just for you!




Already a member?

Sign In Now »