To print: Select File and then Print from your browser's menu

Title: First Seven-Day Treatment of H. Pylori Infection Approved by FDA

"First Seven-Day Treatment of H. Pylori Infection Approved by FDA"

Aciphex (rabeprazole sodium) Plus Antibiotics Faster Than Currently Approved Options TEANECK, NJ and TITUSVILLE, NJ -- November 14, 2002 -- Aciphex, a proton pump inhibitor (PPI) widely prescribed for gastroesophageal reflux disease (GERD), is now approved by the Food and Drug Administration as part of the first seven-day treatment for Helicobacter pylori (H. pylori) infection, the single most common cause of peptic ulcers. Taken in combination with certain antibiotics, Aciphex offers a faster therapy option than other PPIs, treating H. pylori in up to half the time of current 10 to 14 day treatments. When used in combination with amoxicillin and clarithromycin as a three-drug regimen, Aciphex is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history within the last five years) to eradicate H. pylori. Up to 60 million American adults are currently infected with H. pylori (a type of bacteria in the stomach); as many as one in 10 Americans will develop an ulcer in their lifetime. "Using Aciphex, plus antibiotics for one week to eradicate H. pylori is a faster treatment option than what is currently available," said Nimish Vakil, M.D., Clinical Professor of Medicine at the University of Wisconsin Medical School (Milwaukee, Wis.). "When you consider the fact that the majority of duodenal and gastric ulcers are caused by H. pylori infection and that a short treatment course eradicates the infection and prevents relapse, you can understand the importance of this infection in ulcer disease." A multicenter, double-blind, placebo-controlled trial was conducted in 803 patients infected with H. pylori at 47 centers nationwide. In the study, 84 percent of patients treated with Aciphex® (rabeprazole sodium), amoxicillin and clarithromycin taken twice daily were free of H. pylori after seven days of therapy. Eighty-six percent of patients taking the identical regimen achieved the same result after 10 days of treatment, with no significant difference obtained with three additional days of therapy. H. pylori was eradicated in 82 percent of patients treated with a combination of omeprazole, amoxicillin and clarithromycin taken twice daily for 10 days based on per protocol analysis. The three-day Aciphex, amoxicillin and clarithromycin treatment arm was clinically sub-optimal for H. pylori eradication. Eradication of bacteria was determined by a negative Urea Breath Test (13C-UBT) at 42 or more days after the end of therapy. In clinical trials using combination therapy with rabeprazole plus amoxicillin and clarithromycin (RAC), no adverse events unique to this drug combination were observed. In the U.S. multicenter study, the most frequently reported drug related adverse events for patients who received RAC therapy for seven or 10 days were diarrhea (8 percent and 7 percent) and taste perversion (6 percent and 10 percent) respectively. No clinically significant laboratory abnormalities particular to the drug combinations were observed. For more information on adverse events or laboratory changes with amoxicillin or clarithromycin, refer to their respective package prescribing information. Clarithromycin is contraindicated in patients taking cisapride or pimozide; or in patients with a known hypersensitivity to clarithromycin or any macrolide antibiotic. Clarithromycin may elevate digoxin serum concentrations. Serum digoxin levels should be carefully monitored while digoxin and clarithromycin are taken concomitantly. Clarithromycin should not be used in pregnant women except in circumstances where no alternative therapy is appropriate. Amoxicillin is contraindicated in patients who are allergic to any penicillin. About Aciphex®(rabeprazole sodium) Aciphex is also indicated for the treatment of symptomatic GERD, healing of erosive GERD, maintenance of healed erosive GERD, healing of duodenal ulcers and treatment of symptoms related to these conditions. In addition, Aciphex is approved for the treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome, a rare disorder that causes the stomach to produce excess acid. Aciphex has a well-established safety record. In studies, the most common side effect possibly related to Aciphex was headache (2.4 percent vs 1.6 percent for sugar pill). Aciphex should not be used if you have had an allergic reaction to Aciphex, its tablet ingredients, or any proton pump inhibitor (PPI). Reduction in symptoms during treatment with Aciphex does not rule out the presence of gastric malignancy. Patients treated with a PPI, like Aciphex, and warfarin (such as Coumadin®(1)) may need to be monitored more closely by their doctor. Aciphex is a registered trademark of Eisai Co., Ltd., Tokyo, Japan, and is co-promoted by Eisai Inc. and Janssen Pharmaceutica, Inc. in the United States. About Eisai Inc. Eisai Inc. is a U.S. pharmaceutical subsidiary of Eisai Co., Ltd., a research-based human health care company that discovers, develops and markets products in more than 30 countries. Established in 1995, Eisai Inc. began marketing its first product in the United States in 1997 and has rapidly grown to become an integrated pharmaceutical business with sales of more than $1 billion in fiscal year 2001 (year ending March 31, 2002). Eisai Inc. employs a total of more than 600 people at its headquarters in Teaneck, N.J., at its state-of-the-art pharmaceutical production and formulation research and development facility in Research Triangle Park, N.C., and in the field. Between 1998 and 2001, Eisai Inc. moved up rapidly in the rankings of U.S. pharmaceutical companies (based on revenues) from No. 44 to 23. About Janssen Pharmaceutica, Inc. Janssen Pharmaceutica, Inc. markets therapies for gastrointestinal disorders, psychiatric and neurological conditions, chronic pain, and fungal infections. Janssen Pharmaceutica, Inc.'s international operations are headquartered in Beerse, Belgium, with affiliates in 32 countries; Janssen's U.S. headquarters are based in Titusville, NJ. Janssen Pharmaceutica, Inc. is a wholly owned subsidiary of Johnson & Johnson, the world's most comprehensive manufacturer of health care products and related services. For more information about Aciphex(rabeprazole sodium) visit http://www.aciphex.com or call Eisai Inc. at 1-888-4ACIPHEX or Janssen Pharmaceutica, Inc. at 1-800-JANSSEN. Please see package insert or link below for full prescribing information: References: (1) Coumadin is a registered trademark of Bristol-Myers Squibb Pharma Company. SOURCE: Eisai Inc.; Janssen Pharmaceutica, Inc.

Copyright © 2009 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content.