Wyeth Pharmaceuticals, a division of Wyeth, announced that the US Food and Drug Administration (FDA) approved the reformulation of the stomach acid suppressant, Protonix IV (pantoprazole sodium) for Injection. The reformulation eliminates the need for an in-line filter, a previously required extra step in an already time-sensitive procedure to administer the medication to patients requiring immediate acid suppression.

Protonix is the first and only proton pump inhibitor (PPI) in the United States to be offered in both oral and intravenous (IV) formulations.

The new formulation will replace the existing Protonix IV formulation, which has been used clinically for seven years in more than five million patients worldwide.

"Protonix IV, currently used in over 5,000 hospitals, has established a high standard of care for I.V. PPI therapy," said Joseph Camardo, senior vice president of Global Medical Affairs and Medical Director for Wyeth Pharmaceuticals North America. "Without the need for a filter, the reformulated product is more convenient for hospital pharmacists and nurses to use."

The new formulation has been approved for administration either as a 2-minute or 15-minute infusion. Protonix I.V. received FDA approval in December 2003 for administration as a 2-minute infusion. This alternative infusion approach may reduce drug preparation time and administration costs in hospitals, since the intravenous admixture bag can be replaced with a less expensive syringe for administration.

The FDA first approved Protonix IV in March 2001 for the short-term, treatment (7 to 10 days) of patients having gastroesophageal reflux disease (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. Safety and efficacy of Protonix IV as an initial treatment of patients having GERD with a history of erosive esophagitis have not been demonstrated.

Protonix IV received expedited FDA approval in October 2001 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 IV were injection site reactions (including thrombophlebitis and abscess), headache, diarrhea, nausea, and dyspepsia. Protonix IV is contraindicated in patients with known hypersensitivity to any component of the formulation.