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Protonix (Pantoprazole Sodium) Delayed-Release Tablets Approved For Long-Term Treatment of Zollinger-Ellison Syndrome First and Only PPI with IV and Oral Formulations Approved To Treat This Serious Acid-Related Disease MADISON, NJ -- May 3, 2002 -- Wyeth announced that PROTONIX® (pantoprazole sodium) Delayed-Release Tablets were approved by the U.S. Food and Drug Administration (FDA) for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome, on April 19, 2002. PROTONIX® is the first and only proton pump inhibitor (PPI) with both oral and intravenous (IV) formulations approved in the U.S. for the treatment of this chronic and potentially fatal disease. PROTONIX® I.V. was approved for treatment of this condition on October 19, 2001. PROTONIX® is marketed in the U.S. by Wyeth Pharmaceuticals. "Zollinger-Ellison Syndrome is a painful and potentially deadly disease," says Victoria Kusiak, M.D., Vice President and Medical Director for Wyeth Pharmaceuticals North America. "Both PROTONIX® I.V. and tablets are now approved for this condition. Patients can now use the tablets for their long-term treatment and can be treated with the I.V. formulation for up to six days when appropriate." About Zollinger-Ellison Syndrome Zollinger-Ellison Syndrome is a rare disease typically affecting people between the ages of 30 and 50. It is caused by a neuroendocrine tumor called a gastrinoma that is usually located in the pancreas or the duodenum, a portion of the small intestine. 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. Zollinger-Ellison patients often suffer from severe ulceration of the upper gastrointestinal tract. Symptoms of Zollinger-Ellison Syndrome include burning pain in the abdomen, diarrhea, nausea, fatigue, and weight loss. With this disease, acid levels are not controlled easily by standard treatment and may lead to serious complications. About the Clinical Trial The FDA approved PROTONIX® Delayed-Release Tablets for this indication based primarily on a multicenter, phase III study of 35 patients who had either Zollinger-Ellison Syndrome (26 patients) or other hypersecretory conditions (9 patients). Results showed that acid output was controlled for most patients for up to six months, regardless of disease progression. At six months, 94 percent of patients had responded to treatment. Adverse events reported in the trial were consistent with the safety profile of the drug in other populations. The dosage of PROTONIX® in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult starting dose is 40 mg twice daily. Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered. Some patients have been treated continuously with PROTONIX® for more than two years. About PROTONIX® Delayed-Release Tablets PROTONIX® is the first and only PPI in the U.S. available in both oral and intravenous formulations. PROTONIX® Delayed-Release Tablets are indicated for (1) the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis associated with gastroesophageal reflux disease (GERD). For those patients who have not healed after 8 weeks, an additional 8-week course of PROTONIX® may be considered; (2) maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in patients with GERD. Controlled studies did not extend beyond 12 months; and now (3), the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome. There are no known clinically relevant drug interactions with PROTONIX®. (Please see Clinical Pharmacology and Precautions Sections of full Prescribing Information). The most frequently reported adverse events with PROTONIX® Delayed-Release Tablets are headache and diarrhea. Symptomatic response to therapy does not preclude the presence of gastric malignancy. PROTONIX® is contraindicated in patients with known hypersensitivity to any component of the formulation. Please see full Prescribing Information. About PROTONIX® I.V. The FDA first approved PROTONIX® I.V. in March 2001 for the short-term treatment (seven to 10 days) of patients having GERD with a history of erosive esophagitis, as an alternative to oral therapy in patients who are unable to continue taking PROTONIX® Delayed-Release Tablets. PROTONIX® I.V. received expedited FDA approval for the Zollinger-Ellison Syndrome indication in October 2001. The drug is indicated for the treatment of pathological hypersecretory conditions associated with Zollinger-Ellison Syndrome or other neoplastic conditions. In clinical trials, the most frequently reported adverse events with PROTONIX® I.V. were injection site reactions (including thrombophlebitis and abscess), headache, diarrhea, nausea, and dyspepsia. PROTONIX® I.V. is contraindicated in patients with known hypersensitivity to any component of the formulation. Anaphylaxis has been reported. Treatment with PROTONIX® I.V. should be discontinued as soon as the patient is able to be treated with PROTONIX® Delayed-Release Tablets. Please see full Prescribing Information. Safety and efficacy of PROTONIX® I.V. as an initial treatment of patients having GERD with a history of erosive esophagitis have not been demonstrated. PROTONIX® I.V. has been used in more than 1.3 million patients worldwide and is approved in 52 countries. There are no known clinically relevant drug interactions with PROTONIX® I.V. (Please see Clinical Pharmacology and Precautions Sections of full Prescribing Information.) Background Information Proton pump inhibitors are one of the most widely prescribed classes of medications in the United States. The first proton pump inhibitor was launched in the U.S. in 1989. Since 1994, pantoprazole delayed-release tablets have been marketed in 92 countries by Byk Gulden, of Konstanz, Germany, the originator of the compound. To date, pantoprazole delayed-release tablets have been prescribed to more than 60 million patients worldwide. About Wyeth Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, cardiovascular disease, central nervous system, inflammation, hemophilia, oncology and vaccines. Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health. SOURCE Wyeth E-mail this page to a friend or colleague! To print, use this version