NEW YORK, Aug 23 (Reuters Health) -- The US Food and Drug Administration (FDA) has approved the drug rabeprazole sodium (Aciphex), for the treatment of duodenal ulcers and gastroesophageal ('acid') reflux disease, also known as GERD.
The FDA also approved Aciphex for the treatment of rare conditions that feature multiple ulcers, including Zollinger-Ellison syndrome, a chronic condition caused by a tumor that boosts the secretion of stomach acid.
Aciphex is co-marketed by two companies -- Teaneck, New Jersey-based Eisai Inc., and Janssen Pharmaceutica of Beerse, Belgium. In a statement issued by the companies, Dr. Malcolm Robinson, clinical professor of medicine at the University of Oklahoma College of Medicine said, "our research shows that Aciphex demonstrates features, such as consistent acid control from the first dose, that should prove attractive to physicians who treat (gastrointestinal) disorders."
The companies estimate that there are 60 million Americans with gastroesophageal reflux disease who experience heartburn at least once a month, and 25 million with symptoms of these conditions on a daily basis.
In clinical studies of Aciphex, headache was the most common side effect and occurred in 2.4% of patients taking the drug compared with 1.6% of placebo (dummy) patients. The drug is currently sold in the UK, the European Union, and Japan under the trade name Pariet.
