Tokyo (November 14, 2002) Eisai Medical Research Inc. (Headquarters: New Jersey, President: Mindell Seidlin), a U.S. clinical research subsidiary of Eisai Co., Ltd. (Headquarters: Tokyo, President: Haruo Naito), received approval from the U.S. Food and Drug Administration for a new indication for ACIPHEX , a proton pump inhibitor, on November 8 (U.S. Time). With this new approval, ACIPHEX is now indicated for Helicobacter pylori (H. pylori , a type of bacteria in the stomach) eradication to reduce the risk of duodenal ulcer reoccurrence. ACIPHEX is approved for administration for seven days, and is concomitantly administered with antibiotics (Clarithromycin and Amoxicillin). ACIPHEX is the first proton pump inhibitor approved for seven-day administration from the FDA. Other currently available treatment regimens in the U.S. require 10 to 14 days of proton pump inhibitor administration for H. pylori eradication.
H. pylori is a type of bacteria believed to be a common cause of peptic ulcers in the U.S., and up to 60 million American adults are infected with H. pylori . As many as one in 10 Americans who are infected with this bacteria suffer from an ulcer. In the clinical studies on the concomitant administration of ACIPHEX with two antibiotics to treat H. pylori infection, complete eradication was achieved in 84 percent of patients treated for seven days and 86 percent of patients treated for ten days respectively. Adverse events associated with administration of the ACIPHEX and antibiotics regimen in these trials were mainly diarrhea and taste perversion while other clinically significant adverse symptoms were not observed.
ACIPHEX is classified as a proton pump inhibitor, and effectively suppresses gastric acid secretion while inhibiting enzyme activity during the last phase of stomach acid secretion. The other indications for ACIPHEX already approved in the U.S. are as follows: treatment of symptomatic GERD, healing of erosive GERD, maintenance of healed erosive GERD, healing of duodenal ulcers and treatment of hypersecretory conditions, including Zollinger-Ellison syndrome.