Lexicon announced that the Food and Drug Administration (FDA) has approved Xermelo (telotristat ethyl) tablets as the first oral treatment for carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy.
Carcinoid syndrome is a rare condition that is characterized by frequent and debilitating diarrhea, as well as facial flushing, abdominal pain, fatigue, and heart valve damage. It occurs in patients with metastatic neuroendocrine tumors (mNETs).
The safety and efficacy of Xermelo were evaluated in a 12-week, double-blind, placebo-controlled study (n=90) in adults with well-differentiated mNETs and carcinoid syndrome diarrhea. Patients continued their SSA treatment and were randomized to add placebo or Xermelo three times daily. The data showed 33% of patients who added Xermelo had an average reduction of two bowel movements per day vs. 4% of patients who added placebo.
Xermelo works by inhibiting tryptophan hydroxylase, an enzyme that mediates the rate limiting step in serotonin biosynthesis. Serotonin plays a role in mediating secretion, motility, inflammation, and sensation of the gastrointestinal tract, and is overproduced in patients with carcinoid syndrome. Xermelo reduces the production of peripheral serotonin and the frequency of carcinoid syndrome diarrhea.
Xermelo will be available as a 250mg strength tablet in four weekly boxes containing 7 daily dose packs of 3 tablets each. Each monthly case contains 84 tablets. Xermelo will be available in select specialty pharmacies starting March 6, 2017.
For more information call (844) 539-7427 or visit Xermelo.com.