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Protonix Intravenous (Pantoprazole Sodium) For Acid Reflux Available In US MADISON, NJ -- May 17, 2001 -- American Home Products Corporation announced today that Protonix® Intravenous (I.V.) for Injection is now available on hospital pharmacy shelves. Protonix is the first intravenous formulation of the popular gastrointestinal drug class known as proton pump inhibitors (PPI). Protonix I.V., approved by the U.S. Food and Drug Administration (FDA) on March 23 of this year, is indicated for the short-term treatment (seven to 10 days) of gastroesophageal reflux disease (GERD) as an alternative to oral therapy in patients who are unable to continue taking Protonix Delayed-Release Tablets. Safety and efficacy of Protonix I.V. for Injection as an initial treatment for GERD have not been demonstrated. The new product is marketed by Wyeth-Ayerst Laboratories, the pharmaceutical division of American Home Products Corporation. Protonix I.V. is the first intravenous formulation available in the U.S. of the popular gastrointestinal (GI) drug class known as proton pump inhibitors. Until now, physicians have used intravenous H2 antagonists to manage patients unable to take oral therapies. These agents were prescribed to approximately four million hospitalized patients last year. Intravenous H2 antagonists make up 25 percent of the overall hospital acid suppression market, while oral acid suppressants control 75 percent of the market, and oral PPI sales in the hospital market total $204 million annually. "This is an important progression in therapy for GERD. It comes at a time when the use of PPIs is increasing in the hospital setting at a rate of 30 percent per year," says Harold K. Marder, M.D., Senior Vice President of Global Medical Affairs, Wyeth-Ayerst Laboratories. "With the addition of the I.V. formulation, Protonix is a more valuable clinical tool in the hospital setting. Protonix is the only acid suppressant available in both an I.V. and an oral formulation that has not exhibited evidence of tolerance (loss of efficacy)." Last year, the FDA approved Protonix Delayed-Release Tablets, which are indicated for the short-term (up to 16 weeks) healing and symptomatic relief of erosive esophagitis (EE) associated with GERD. In U.S. studies, Protonix has also been shown to provide complete elimination of nighttime heartburn and regurgitation. Recent studies have shown that nighttime GERD symptoms may be associated with more serious complications such as Barrett's esophagus (a precancerous condition) and esophageal cancer. "Protonix Delayed-Release Tablets and Protonix I.V. provide an ideal treatment combination for hospitalized patients," said Dr. Marder. "They both offer the reliability of PPI acid suppression. The 40 mg dosing provides consistent gastric acid control when transitioning a patient from the oral to the I.V. formulation." Filters will be supplied with each box of Protonix I.V. The filter must be used to remove the precipitates that may form when the reconstituted drug product is mixed with I.V. solution. Gastroesophageal reflux disease (GERD) is 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. According to an American Gastroenterology Association National survey, nearly 50 million Americans experience nighttime heartburn. If left untreated or uncontrolled, esophageal damage caused by GERD may lead to even more serious complications, including stricture, hemorrhage, Barrett's esophagus, and esophageal cancer. Protonix has been evaluated in more than 100 clinical trials worldwide, involving more than 45,000 patients. Protonix I.V. has been used in more than 1.3 million patients worldwide and is approved in 43 countries. There are no known clinically relevant drug interactions with Protonix. The most frequently reported adverse events with Protonix Delayed-Release Tablets are headache and diarrhea and with Protonix I.V. are abdominal pain, chest pain, rash, and pruritus. Symptomatic response to therapy does not preclude the presence of gastric malignancy. Protonix (oral/I.V.) is contraindicated in patients with known hypersensitivity to any component of the formulation. Protonix oral is indicated for short-term treatment (up to 16 weeks) of erosive esophagitis associated with GERD. Protonix I.V. is indicated for the short-term treatment (seven to 10 days) of GERD as an alternative to oral therapy in patients who are unable to continue taking Protonix Delayed-Release Tablets. 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. SOURCE: American Home Products Corporation Related Links: Protonix, Wyeth-Ayerst Laboratories and American Home Products Corporation. E-mail this page to a friend or colleague! To print, use this version