GERD

Gastroesphageal reflux disease (GERD) is a chronic condition caused by stomach contents leaking back into the esophagus on a regular basis. GERD leads to painful symptoms like heartburn and tissue damage.

The medical community agrees that GERD needs to be well controlled not only because it causes discomfort, diminishing quality of life, but it can lead to more serious conditions including erosion, bleeding and, in some cases, cancer.

In the United States, the current prevalence of GERD is estimated to be 15% of the adult population and in European countries the prevalence varies between 10% and 25%. The incidence of nocturnal GERD (i.e. GERD symptoms occurring at night) in the overall population is currently reported to be as high as 10%. Obesity, pregnancy, diabetes mellitus and smoking are risk factors for developing GERD.

The market size for GERD drugs, such as antacids and anti-ulcerants, has been estimated to be about $20 billion per year. Proton pump inhibitors (PPI), like Nexium, and histamine H2 antagonists, like Zantac, are the main treatments and are thought to represent 91% of all antacid and anti-ulcerant drug sales. Although acid suppressants have been highly commercially successful, studies indicate that GERD symptoms are not adequately controlled in 20% to 50% of treated patients, especially at night.

This is not entirely surprising because the fundamental cause of GERD is not gastric acid overproduction but a dysfunction of the muscle at the bottom of the esophagus, known as the lower esophageal sphincter. Acid suppressant drugs, although effective at reducing symptoms for many patients, do not have any effect on the lower esophageal sphincter and do not prevent reflux from occurring; they merely render the refluxed material less acidic. As symptoms and damage to the esophagus can also be caused by nonacidic reflux, patients may still suffer from GERD – and the associated health risks – despite optimal doses of acid suppressing medication.

A drug which acts on the function of the lower esophageal sphincter to prevent inappropriate reflux, would provide a physiological answer to the problem of GERD.

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