Xermelo Approval History
- FDA approved: Yes (First approved February 28th, 2017)
- Brand name: Xermelo
- Generic name: telotristat ethyl
- Dosage form: Tablets
- Company: Lexicon Pharmaceuticals, Inc.
- Treatment for: Carcinoid Syndrome Diarrhea
Xermelo (telotristat ethyl) is an oral tryptophan hydroxylase inhibitor indicated for use in combination with somatostatin analog (SSA) therapy for the treatment of carcinoid syndrome diarrhea in patients with metastatic neuroendocrine tumors.
FDA approval of Xermelo was based on the results of a 12-week, placebo-controlled trial in 90 adult patients experiencing carcinoid syndrome diarrhea despite receiving SSA therapy for at least three months. Of the patients receiving Xermelo in addition to SSA treatment, 33 percent experienced an average reduction of two bowel movements per day, compared to four percent of those receiving a placebo in addition to SSA.
Xermelo is a tablet administered orally three times daily with food. Xermelo may cause constipation, which can be serious. Common side effects include nausea, headache, increased levels of the liver enzyme gamma-glutamyl transferase (GGT), depression, peripheral edema, flatulence, decreased appetite, and fever.
Development History and FDA Approval Process for Xermelo
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.