Prilosec Now Available to Treat Gastric Ulcers
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Prilosec Now Available to Treat Gastric Ulcers

WAYNE, Pa., March 25, 1996 --Astra Merck Inc., has received clearance from the Food and Drug Administration to market its antisecretory prescription medication Prilosec(R) (omeprazole) for the short-term treatment of active benign gastric ulcers.

The first of a class of medications called proton pump inhibitors, Prilosec(R) targets acid production at its source, slowing production of acid from the cells of the stomach lining. In clinical trials of patients with endoscopically diagnosed gastric ulcer, the percentage of patients with ulcers healed at week eight with Prilosec(R) was about 85%.

An ulcer is a lesion that forms in the lining of the stomach or the duodenum (the upper part of the small intestine). Recent research shows that most gastric ulcers develop as a result of infection with bacteria called Helicobacter pylori (H. pylori). The bacteria produces substances that weaken the stomach's protective mucus and make the stomach more susceptible to damaging effects of acid and pepsin.

Gastric ulcers are found throughout the stomach, but most commonly along the lesser curvature of the stomach. They tend to be larger in size and carry a higher mortality rate than duodenal ulcers.

About 20 million Americans develop at least one peptic ulcer during their lifetime. Each year, ulcers affect about five million people, with more than one million of them hospitalized for the condition. Ulcers cost the health care system more than $2 billion per year for direct costs. Indirect costs -- time lost from work, time spent unproductively -- are more than $500 million.

Prilosec(R) has been used in more than 135 million patient treatments during the 14 years that it has been available as a therapy around the world. The medication is generally well tolerated; side effects, which are usually mild and transient, include headache, diarrhea, abdominal pain and nausea. The recommended dose for gastric ulcer is 40 mg once daily for four to eight weeks.

In addition to the indication for gastric ulcers, Prilosec(R) is also used as short-term treatment of duodenal ulcers, erosive esophagitis and poorly-responsive symptomatic gastroesophageal reflux disease. It is also indicated to maintain healing of erosive esophagitis and for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

Prilosec(R) was discovered by scientists from Astra AB of Sweden, one of the world's fastest growing pharmaceutical companies. It has been marketed in the U.S. since 1989 and is the most prescribed drug among gastroenterologists in the U.S.

Astra Merck, previously a unit of Merck & Co., Inc. (NYSE: MRK), was reorganized as a separate company in November, 1994, owned equally by Merck and Astra AB. In addition to Prilosec(R), the company markets the cardiovascular drugs Plendil(R) (felodipine) and Tonocard(R) (tocainide HCl).

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