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| |  FDA Approves Protonix (Pantoprazole) Intravenous for Acid Control in Zollinger-Ellison Syndrome MADISON, NJ -- October 22, 2001 -- American Home Products Corporation announced today that Protonix® (pantoprazole sodium) Intravenous has been approved on an expedited schedule by the U.S. Food and Drug Administration (FDA) for the treatment of pathological hypersecretory conditions associated with Zollinger-Ellison Syndrome or other neoplastic conditions. Protonix Intravenous (I.V.) is the first and only intravenous proton pump inhibitor (PPI) to be approved in the U.S. for the treatment of this rare, chronic and potentially fatal disease that involves tumors of the pancreas and causes gastroduodenal ulcers. Protonix I.V. is marketed in the U.S. by Wyeth-Ayerst Laboratories, the pharmaceutical division of American Home Products. Today's approval provides the first and only I.V. PPI treatment for Zollinger-Ellison Syndrome patients who are unable to take oral medications. Prior to this approval, these hospitalized patients would have received an I.V. H(2) receptor antagonist. Proton pump inhibitor therapy provides very effective control of acid output and does not exhibit evidence of tolerance (loss of efficacy). Without treatment with effective acid-blocking drugs, Zollinger-Ellison Syndrome can cause severe bleeding ulcers. "Zollinger-Ellison Syndrome is a painful and potentially deadly disease, so the sooner we can control acid production, the better," says Joseph R. Pisegna M.D., Chief, Division of Gastroenterology and Hepatology, VA Greater Los Angeles Healthcare System in Los Angeles, California. "In clinical trials, Protonix I.V. acted quickly, within one hour, and maintained continuous acid control for up to 24 hours, making a critical difference for my patients. In fact, in several of these patients, Protonix clearly played a life-saving role." "The use of PPIs in the hospital setting is increasing at a rate of 12 percent per year, so this expanded FDA approval can't come at a better time for hospital physicians," says Harold K. Marder, M.D., Senior Vice President of Global Medical Affairs, Wyeth-Ayerst Laboratories. "Wyeth-Ayerst is pleased to have brought to market a product that is already well-established in the gastrointestinal arena, and now, in clinical trials, was effective for 100 percent of patients with Zollinger-Ellison Syndrome." The application for the Zollinger-Ellison Syndrome indication was granted "priority review" by the FDA, an expedited review process reserved for products that provide significant improvement over available therapies in the treatment, diagnosis, or prevention of a disease. Zollinger-Ellison Syndrome is caused by a neuroendocrine tumor called a gastrinoma, that is usually located in the pancreas and duodenum, a portion of the small intestine. Zollinger-Ellison patients often suffer from severe ulceration of the upper gastrointestinal tract. As a result of the tumor, there are high circulating levels of the hormone gastrin, which result in the stimulation of the parietal cell to produce excessive levels of gastric acid secretion. This often causes duodenal ulcers and the potential for life-threatening hemorrhage. The disease usually affects people between the ages of 30 and 60, striking approximately six of every 100,000 people. Symptoms of Zollinger-Ellison Syndrome include burning pain in the abdomen, diarrhea, nausea, fatigue, and weight loss. With this disease, ulcers do not respond easily to standard treatment. Protonix I.V. is the only PPI treatment for these patients when oral medication is not an option. SOURCE: American Home Products Corporation Related Links: Protonix (pantoprazole sodium) and American Home Products Corporation.
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