American Home Products Corporation announced on Friday that Protonix ® IV intravenous formulation has been approved by the US Food And Drug Administration (FDA) for 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 ® (pantoprazole sodium) Delayed-Release Tablets. Protonix ® is the first proton pump inhibitor (PPI) in the US available in both oral and intravenous formulations. Safety and efficacy of Protonix ® IV for Injection as an initial treatment for GERD have not been demonstrated. Protonix ® is marketed by Wyeth-Ayerst Laboratories -- the pharmaceutical division of AHP.

The Market

Protonix ® IV is the first intravenous formulation available in the US of the popular gastrointestinal (GI) drug class known as proton pump inhibitors (PPI). 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. Protonix ® IV is the first intravenous proton pump inhibitor available in the US and Protonix ® IV will compete in the hospital market with the IV H2 antagonists.

Protonix ®

Friday's approval by the FDA follows last year's approval of 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 US 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 ® IV must be used with an in-line filter, and the appropriate filters will be supplied with each box. Protonix ® IV final packaging will take place over the next 1-2 weeks and final release of the product is scheduled for mid April. Questions on product specifications or availability can be directed to the Wyeth-Ayerst Customer Service department at 1-800-666-7248.

GERD: The Disease

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.

Clinical Experience

Protonix ® (pantoprazole sodium) has been evaluated in more than 100 clinical trials worldwide, involving more than 45,000 patients. Protonix ® IV 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 ® IV 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 ® IV 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 ® (pantoprazole sodium) Delayed-Release Tablets. Treatment with Protonix ® IV should be discontinued as soon as the patient is able to be treated with Protonix ® Delayed-Release Tablets.

Background Information