To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Clears First Combination Therapy To Cure Cause of Ulcers URL: http://www.pslgroup.com/dg/77B6.htm Doctor's Guide April 15, 1996
WAYNE, Pa., April 15, 1996 -- Astra Merck Inc. announced it has received clearance from the U.S. Food and Drug Administration (FDA) today to market its antisecretory medication Prilosec(R) (omeprazole) in combination with the antibiotic Biaxin(R) (clarithromycin) for the treatment of patients with H. pylori infection and duodenal ulcer to eradicate H. pylori, the bacteria now believed to cause approximately 90 percent of peptic ulcers. H. pylori eradication has been shown to reduce the risk of duodenal ulcer recurrence. Prilosec is marketed by Astra Merck Inc. and Biaxin is marketed by Abbott Laboratories. This first combination treatment for eradicating H. pylori offers millions of patients who suffer from duodenal ulcers a new chance at a cure of the cause of this condition. It also means that patients with ulcers may no longer have to suffer from the pain and discomfort of recurring ulcers, or the cost and inconvenience associated with taking life-long antiulcer medications. In clinical trials, the combination of Prilosec and Biaxin had H. pylori eradication rates of up to 83 percent. Among patients in whom H. pylori has been eradicated, ulcer recurrence rates have been as low as five percent six months after therapy. The recommended dosage for eradicating H. pylori is Prilosec 40 mg once daily and Biaxin 500 mg three times daily for the first 14 days, followed by Prilosec 20 mg once daily for days 15-28. The Prilosec- Biaxin regimen has been generally well tolerated: side effects, which are usually mild and transient, include taste perversion, nausea, headache. "The Prilosec-Biaxin regimen for treating H. pylori-induced ulcers means that patients may finally be able to receive a treatment that not only resolves symptoms and heals the ulcers, but may also cure the underlying cause of ulcers and reduce the risk of the ulcer coming back," said Irwin Scher, M.D., Astra Merck Inc.'s vice president for drug development and medical affairs. Peptic ulcers affect approximately five million Americans each year. It is estimated that 10 percent of the population will develop an ulcer during their lifetime. In the past, ulcers were believed to be caused by lifestyle factors such as stress and diet. Later, researchers discovered that an imbalance between digestive fluids and the stomach's ability to defend itself against these powerful substances resulted in ulcers. However, researchers now know that the H. pylori bacteria (along with acid secretion) damages stomach and duodenal tissue, causing inflammation and ulcers in 90 percent of ulcer patients. Treatment with Prilosec and Biaxin is considered a dramatic medical advance because elimination of H. pylori means that the ulcer will not only heal but also will not likely come back. H. pylori is a spiral-shaped bacterium found in the stomach. Like most germs, H. pylori bacteria is thought to be transmitted from person-to-person contact. Experts believe the activity of the bacteria damages and weakens the barrier that protects the stomach and duodenum, eventually causing the ulcer. In some people, the infection persists lifelong. Infection with H. pylori has also been linked to a number of other gastrointestinal diseases, including stomach cancer. An ulcer is a sore or lesion that forms in the lining of the stomach or duodenum where acid and pepsin are present. Symptoms of ulcers include a gnawing or burning pain in the upper abdomen (often occurring between meals and early in the morning), and, sometimes, nausea, vomiting and loss of appetite and weight. Although ulcers can develop at any age, they are most prevalent in people over the age of 30. "The discovery of the H. pylori link to ulcers is revolutionary because it means that ulcers can not only be treated, but cured with medications that have been shown to eradicate the H. pylori bacteria and heal the ulcer," said Barry Marshall, M.D., the researcher who discovered H. pylori in 1983. "I believe that in most cases the Prilosec-Biaxin regimen will serve as a very effective treatment for most patients with ulcers." Prilosec is currently indicated as first-line therapy for erosive esophagitis, for the maintenance of healed erosive esophagitis, for symptomatic gastroesophageal reflux disease (GERD) that is poorly responsive to customary medical treatment and 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. Biaxin is indicated for the treatment of mild-to-moderate infections, including upper-respiratory tract infections, lower-respiratory tract infections and uncomplicated skin and skin-structure infections. Astra Merck, previously a unit of Merck & Co., Inc., was reorganized as a separate company in November, 1994, owned equally by Merck and Astra AB of Sweden. Abbott Laboratories is a worldwide manufacturer of health care products. --------------------------------------------------------------------------------------------- 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.