The US Food and Drug Administration (FDA) has approved Lexicon Pharmaceuticals’ Xermelo (telotristat ethyl) tablets in combination with somatostatin analog (SSA) therapy to treat adults with carcinoid syndrome diarrhoea.
Carcinoid syndrome is a cluster of symptoms sometimes seen in people with carcinoid tumours. Carcinoid syndrome occurs in less than 10% of patients with carcinoid tumours, usually after the tumour has spread to the liver.
These tumours are rare, and often slow-growing. Most carcinoid tumours are found in the gastrointestinal tract.
The tumours in patients with carcinoid syndrome diarrhoea release more amounts of hormone serotonin, resulting in diarrhoea.
FDA Center for Drug Evaluation and Research Office of Drug Evaluation III director Julie Beitz said: “Today’s approval will provide patients whose carcinoid syndrome diarrhoea is not adequately controlled with another treatment option.”
"Today’s approval will provide patients whose carcinoid syndrome diarrhoea is not adequately controlled with another treatment option."
Approved in tablet form, Xermelo inhibits the production of serotonin by carcinoid tumours and reduces the frequency of carcinoid syndrome diarrhoea.
The tablet's safety and efficacy were established in a double-blind, placebo-controlled trial carried out in 90 adult participants with metastatic neuroendocrine tumours and carcinoid syndrome diarrhoea for 12 weeks.
The most common side effects of Xermelo include nausea, headache, high levels of the liver enzyme gamma-glutamyl transferase, depression, accumulation of fluid-causing swelling, flatulence, decreased appetite and fever.
The tablet may cause constipation, and the risk of developing this may be high in patients whose bowel movement frequency is less than four bowel movements a day.
Xermelo also received orphan drug designation, which provides incentives to assist the development of drugs for rare diseases.
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