FDA Approves Xermelo, A Drug For Carcinoid Syndrome Diarrhea
Long before, a significant number of experts would regard Carcinoid syndrome as a group of symptoms that one might acquire if a person already has a type of cancer called carcinoid tumors. That said, the US Food and Drug Administration has recently approved Xermelo tablets in combination with somatostatin analog (SSA) therapy, a type of drug that is manufactured by Lexicon Pharmaceuticals as a treatment for adults with carcinoid syndrome diarrhea that SSA therapy alone has inadequately controlled. Lexicon proudly said that it is the first orally administered therapy to treat carcinoid syndrome diarrhea which has the ability to target the root cause of the problem which is the overproduction of hormones.
According to reports revealed by Xconomy, in the U.S. alone, Carcinoid syndrome has been a condition that has already affected 14,000 people that have metastatic neuroendocrine tumors, or mNETs which is noted for being rare, and often slow-growing. Experts say that when these tumors spread to the liver and other organs in the gastrointestinal tract, it can cause carcinoid syndrome, which is characterized by an overproduction of serotonin, cause symptoms such as diarrhea, facial flushing, abdominal pain, fatigue, and heart valve damage. It was found that complications of uncontrolled diarrhea would include weight loss, malnutrition, dehydration, and electrolyte imbalance.
Meanwhile, in one of her statements reported by the U.S. Food & Drug Administration, Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research has revealed that the agency's approval will be able to provide patients whose carcinoid syndrome diarrhea is not adequately controlled with another treatment option. Additionally, Lexicon's CEO Lonnel Coats has highly emphasized that the agency approval comes on the recently concluded Rare Disease Day that annually takes place on February 28; while also highlighting the fact that Xermelo was the first drug developed by the company to receive FDA approval. Lexicon scientists have explained that Xermelo, in a regimen with SSA therapy, has been approved in a tablet form to be taken orally three times daily with food which allegedly inhibits the production of serotonin by carcinoid tumors and reduces the frequency of carcinoid syndrome diarrhea.
On the other hand, experts have also revealed that some of the most common side effects of Xermelo include nausea, headache, and increased levels of the liver enzyme, depression, accumulation of fluid that usually causes swelling, flatulence, decreased appetite and fever. Ultimately, it was found that the drug has also received an orphan drug designation, which allegedly provides a number of incentives to assist and encourage the development of drugs for rare diseases.
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