To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Approves Aciphex For Reflux Disease And Duodenal Ulcers URL: http://www.pslgroup.com/dg/122272.htm Doctor's Guide August 20, 1999
NEW YORK -- Aug. 20 -- PRNewswire -- Eisai Inc. has received marketing clearance from the U.S. Food and Drug Administration for Aciphex™ (rabeprazole sodium), a new proton pump inhibitor (PPI).
Aciphex will be marketed in the United States by Eisai Inc., an affiliate of Eisai Co., Ltd. of Tokyo, Japan, and Janssen Pharmaceutica, a subsidiary of Johnson & Johnson.
The FDA approved Aciphex for healing of erosive gastroesophageal reflux disease (GERD), maintenance of healed erosive GERD and healing of duodenal ulcers. Aciphex also has been approved for the treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
"Our research shows that Aciphex demonstrates features, such as consistent acid control from the first dose, that should prove attractive to physicians who treat GI disorders," said Malcolm Robinson, MD, clinical professor of medicine at the University of Oklahoma College of Medicine, and the founder and medical director of the Oklahoma Foundation for Digestive Research. "This new product will offer patients a highly effective treatment choice."
More than 60 million Americans suffer from GERD and heartburn, a common GERD symptom, at least once a month, and 25 million sufferers report symptoms on a daily basis.(1) Many of these patients have severe symptoms and are often diagnosed with erosions in the lining of the esophagus, a condition called erosive GERD.
Aciphex will be available in 20 mg, enteric-coated tablets to be prescribed once daily.
In clinical trials, Aciphex demonstrated a favorable side-effect profile. Headache was the most common side effect assessed as possibly related to Aciphex (2.4 percent vs. 1.6 percent for placebo). Aciphex is contraindicated in patients with known sensitivity to rabeprazole, substituted benzimidazoles or any component of the formulation. As is the case for other proton pump inhibitors, symptomatic response to therapy with Aciphex does not preclude the presence of gastric malignancy. Proton pump inhibitors, however, are an established class of drugs that has been shown to be safe and well tolerated.
In April 1997, Eisai Co., Ltd. and Janssen Pharmaceutica of Beerse, Belgium, formed a strategic alliance to bring the drug to market.
The Japanese Ministry of Health and Welfare cleared rabeprazole sodium for marketing in 1997, and the drug is successfully marketed there under the trade name Pariet®. Pariet® was approved in the United Kingdom in May 1998, and for marketing in all 14 other European Union countries beginning in September 1998. --------------------------------------------------------------------------------------------- Copyright © 1999 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. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.