Gastroesophageal Reflux Disease

Depomed is currently evaluating the possibility of using AcuForm™ delivery technology to develop an oral, controlled release therapeutic that may specifically address nocturnal acid breakthrough associated with gastroesophageal reflux disease (GERD).

GERD, commonly known as acid reflux, is a chronic condition that affects approximately 55 million to 60 million individuals in the United States. It is a disorder of the digestive system caused by the failure of the lower esophageal sphincter muscle (LES) to close properly, which permits stomach contents to leak back into the esophagus. When stomach contents pass through the LES into the esophagus, stomach acid causes the burning sensation in the chest or throat known as heartburn. Heartburn that occurs more than twice a week may be GERD. Other symptoms of GERD can include acid indigestion, bad breath, chest pain, hoarseness in the morning, and trouble swallowing.

While some GERD therapies provide effective daytime treatment, approximately 50 percent of individuals receiving treatment for GERD continue to experience nocturnal acid breakthrough.

Development Status

Depomed has conducted two proof-of-concept studies evaluating the company's formulation of omeprazole, a generic proton pump inhibitor (PPI).  In August 2007, the company announced positive results from the second study, which was a Phase 2a PK/PD study investigating the effect on nighttime stomach acid levels observed when omeprazole is delivered in two pulses.  Depomed's tablet formulation of omeprazole has the potential when taken with the evening meal to remain in the stomach for 4 - 6 hours and then deliver a second dose such that peak blood levels of omeprazole are achieved at 2 - 3 A.M. when nocturnal acid breakthrough typically sets in.