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| |  FDA Approves Protonix Tablets For Erosive Esophagitis MADISON, NJ -- February 3, 2000 -- American Home Products Corporation announced that Protonix(R) (pantoprazole sodium) Delayed-Release tablets has been approved by the U.S. Food and Drug Administration (FDA). Protonix, the newest of the popular gastrointestinal (GI) drug class known as proton pump inhibitors (PPI), is indicated for the short-term (up to sixteen weeks) treatment in the healing and symptomatic relief of erosive esophagitis (EE).
Protonix represents a major new product opportunity, and the foundation for a new therapeutic franchise, in a rapidly growing $7.5 billion market for Wyeth-Ayerst Laboratories, the pharmaceutical division of American Home Products. The FDA is also currently reviewing an additional new drug application (NDA) from Wyeth for an intravenous (IV) formulation of Protonix. Protonix will be launched in the second quarter 2000 pending the successful completion of an ongoing mouse safety study and FDA approval of the IV form. Erosive esophagitis is one of the more serious forms of gastroesophageal reflux disease (GERD), a chronic condition caused by the reflux (reverse flow) of stomach acid into the esophagus. More than 40 percent of adults -- nearly 60 million Americans -- experience symptoms of GERD (typically a burning pain behind the breastbone) two or more times per week. If left untreated or uncontrolled, esophageal damage caused by GERD may lead to even more serious complications, including stricture, hemorrhage, a precancerous condition known as Barrett's esophagus, and esophageal cancer. "Protonix is a valuable new therapeutic option in the battle against erosive esophagitis; one of the more serious forms of GERD," says Harold Marder, M.D., Senior Vice President of Global Medical Affairs, Wyeth-Ayerst Pharmaceuticals. "In clinical trials, the Protonix 40 mg tablet has been shown to be highly effective in promoting healing of erosive esophagitis and controlling the associated symptoms of this disease," Dr. Marder adds. Protonix (pantoprazole) has been evaluated in more than 100 clinical trials worldwide, involving more than 11,000 patients. In clinical trials, the most frequently reported side effects in patients taking pantoprazole -- headache, diarrhea, and flatulence -- occurred in about the same rates as placebo and nizatidine (a competitive product marketed as Axid). Protonix should not be used by patients with a known hypersensitivity to any component of the formulation. Pregnant women should use the compound only if clearly needed, and physicians should evaluate continuing drug use in nursing mothers. 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. Pantoprazole is currently marketed in 60 countries. It was first launched outside the U.S. in 1994 by Byk Gulden, the originator of the compound. To date, pantoprazole has been prescribed to more than 27 million patients worldwide. Related Links: Protonix (pantoprazole sodium) , Wyeth-Ayerst Laboratories and American Home Products Corporation.
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