To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Prilosec Cleared by FDA For Heartburn and Other Symptoms Of GERD URL: http://www.pslgroup.com/dg/E556.htm Doctor's Guide December 2, 1996
WAYNE, Pa., Dec. 2, 1996 -- Astra Merck Inc. announced today it has received clearance from the U.S. Food and Drug Administration to market its antisecretory medication Prilosec(R) (omeprazole) for use as initial therapy in the treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD). Prilosec is the first and only acid pump inhibitor to receive this indication. "Millions of patients suffering from painful heartburn caused by acid reflux now have a new first-line treatment option that can provide symptom resolution for their condition," said Irwin Scher, MD, Astra Merck's vice president for drug development and medical affairs. "The decision to make Prilosec available to treat heartburn and other symptoms of GERD confirms the effectiveness and safety of Prilosec." Although many people experience heartburn from time to time, patients who get heartburn more than two or three times a week may have a more serious condition called GERD, an acid-related disorder affecting approximately 19 million Americans. GERD results when the lower esophageal sphincter, the muscle between the stomach and the esophagus, or food tube, relaxes allowing harsh stomach acid to splash back into the esophagus. GERD is a potentially serious medical condition which can lead to significant complications, including ulcers, narrowing of the esophagus and precancerous changes within the lining of the esophagus. Because heartburn is the most common symptom of GERD, the disease is often misunderstood and underestimated by patients and doctors. GERD sufferers often endure their symptoms in silence, blaming their condition on lifestyle and eating habits and settling for inadequate, incomplete resolution of their heartburn. Prilosec significantly reduces acid directly at the final site of acid production, the acid pumps in the cells of the stomach. "Now that Prilosec is available for first-line therapy for painful and recurring heartburn, it is essential that patients take their persistent heartburn seriously and seek appropriate treatment," said Dr. Scher. "It is unfortunate that many patients who have GERD do not seek medical help." Prilosec is generally well tolerated; side effects, which are usually transient and mild, include headache, diarrhea, abdominal pain and nausea. The recommended adult dose is 20 mg daily for up to four weeks in patients with symptomatic GERD. In addition to its new indication, Prilosec is also indicated for use in combination with the antibiotic Biaxin(R) (clarithromycin) for the eradication of H. pylori infection associated with duodenal ulcers to reduce the risk of recurrence. H. pylori is the bacterium now believed to cause approximately 90 percent of peptic ulcers. Prilosec is also indicated as first-line therapy for erosive esophagitis, for the maintenance of healed erosive esophagitis, for short-term treatment of active duodenal ulcer and active benign gastric ulcer. It is also indicated for the treatment of certain pathological hypersecretory conditions. Astra Merck is a free-standing joint venture, owned equally by Merck & Co. and Astra AB of Sweden. It has exclusive rights to develop and market most Astra compounds in the U.S. In addition to Prilosec, the company markets the cardiovascular drugs Plendil(R) (felodipine) and Tonocard(R) (tocainide HCl). The company is also awaiting FDA marketing clearance for the oral antihypertensive fixed-dose combination agent Lexxel(TM). --------------------------------------------------------------------------------------------- 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.