Lexicon’s Xermelo gets FDA approval to treat carcinoid syndrome diarrhea


Lexicon Pharmaceuticals’ oral drug Xermelo (telotristat ethyl) 250mg has been approved in combination with somatostatin analog (SSA) therapy by the US Food and Drug Administration (FDA) to treat carcinoid syndrome diarrhea.

What is Carcinoid Syndrome Diarrhea ?

A rare and debilitating condition, carcinoid syndrome diarrhea is a secondary condition in patients suffering from metastatic neuroendocrine tumors (mNETs).

Patients having the carcinoid syndrome struggle with frequent and debilitating diarrhea which makes it difficult for them to lead a normal and predictable life.

Carcinoid syndrome patients also have to bear with facial flushing, pain in abdomen fatigue as well as damage to heart valve over a period of time.

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Representative image for medicines. Photo courtesy of everydayplus/Freedigitalphotos.net.

FDA Approval to Lexicon Pharmaceuticals’ Carcinoid Syndrome Diarrhea Drug

Now there is relief for them finally, courtesy of the FDA approval to Xermelo. The Lexicon Pharmaceuticals’ carcinoid syndrome diarrhea medication will be made available as a prescription drug in select pharmacies from next Monday in the US.

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Lonnel Coats, Lexicon’s president and chief executive officer, commenting on the Xermelo FDA approval said: “The approval of Xermelo represents a shift in the treatment paradigm of carcinoid syndrome diarrhea for cancer patients who are inadequately controlled by SSA therapy, and until now, have had limited options to manage this debilitating condition.

“We are proud to have discovered and developed this ground-breaking orphan drug, and it is an honor to make it available for the thousands of patients currently suffering from this condition who wish to lead a more routine life with fewer incidences of severe diarrhea.”

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Xermelo now holds the distinction of becoming the first and only orally administered carcinoid syndrome diarrhea medication.

How Xermelo Works in Carcinoid Syndrome Diarrhea Treatment

The carcinoid syndrome diarrhea drug targets excess production of serotonin in the mNET cells. To be more precise, Xermelo acts on the tryptophan hydroxylase enzyme that causes the overproduction of serotonin production in the mNET cells.

A monoamine neurotransmitter, serotonin when in high quantity can lead to diarrhea among other side effects.

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Matthew H. Kulke, M.D., TELESTAR primary investigator, director of the Program in Neuroendocrine and Carcinoid Tumors at Dana Farber Cancer Institute and Professor of Medicine, Harvard Medical School said: “Inhibition of tumoral serotonin production represents a novel approach for patients with this condition.  Studies have shown that Xermelo can reduce the debilitating effects of carcinoid syndrome diarrhea and has a favorable efficacy and safety profile in patients who currently have limited treatment options.”

Xermelo’s maker Lexicon retains rights to sell its carcinoid syndrome diarrhea drug, telotristat ethyl in Japan.  The Texas pharmaceutical is into a license and collaboration agreement with Ipsen to market telotristat ethyl in Europe and other countries excluding the US and Japan.

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