23 March 2001 22:21 [Source: ICIS news]
HOUSTON (CNI)--The US Food and Drug Administration (FDA) has approved American Home Products (AHP)'s Protonix IV intravenous formulation for short-term treatment of gastroesophageal reflux disease (GERD), AHP said Friday.
Protonix is the first proton pump inhibitor (PPI) in the US available in both oral and intravenous formulations, the company said, and is marketed by Wyeth-Ayerst Laboratories, the pharmaceutical division of AHP.
The company said its Protonix IV is an alternative to oral therapy in patients who are unable to continue taking Protonix (pantoprazole sodium) delayed-release tablets.
Said Harold Marder, senior vice president of global medical affairs, Wyeth-Ayerst Laboratories: "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% year."
AHP said Protonix IV is the first intravenous formulation available in the US from the popular gastrointestinal (GI) drug class known as proton pump inhibitors (PPI). Until now, physicians have used intravenous histamine 2 (H2) suppressants to manage patients unable to take oral therapies. These agents were prescribed to approximately 4m hospitalised patients last year.
Intravenous histamine 2 acid suppressants make up 25% of the overall hospital acid suppression market while oral acid suppressants control 75% of the market. Oral PPI sales in the hospital market total $204m (Euro229.2m) annually.
American Home Products of Madison, New Jersey is one of the world’s largest research-based pharmaceutical and health care products companies.
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