FDA Approves Protonix for Delayed-Release Oral Suspension

COLLEGEVILLE, Pa. -- Wyeth Pharmaceuticals, a division of Wyeth, announced that the U.S. Food and Drug Administration (FDA) has approved Protonix® (pantoprazole sodium) For Delayed-Release Oral Suspension, a new addition to the Protonix family of prescription medications.

"The availability of Protonix For Delayed-Release Oral Suspension provides adult patients who cannot swallow tablets with an effective and convenient way to treat their erosive gastroesophageal reflux disease (GERD)," says gastroenterologist Richard Lynn, MD, senior director, global medical affairs for Wyeth Pharmaceuticals.

Protonix is one of the leading treatments for patients with erosive GERD. The addition of Protonix For Delayed-Release Oral Suspension builds upon the successful Protonix family of products, which also includes Protonix Delayed-Release Tablets and Protonix I.V. For Injection. The new Protonix For Delayed-Release Oral Suspension provides comparable acid suppression to Protonix Tablets.

Protonix For Delayed-Release Oral Suspension can be administered orally in applesauce or apple juice, or through a nasogastric (NG) tube. Protonix For Delayed-Release Oral Suspension is indicated for the treatment and maintenance of healing of erosive esophagitis with associated gastroesophageal reflux disease (GERD) symptoms. Controlled studies did not extend beyond 12 months.

The adverse reaction profile of Protonix For Delayed-Release Oral Suspension is similar to the established safety profile of Protonix Delayed- Release Tablets. In clinical trials, the most frequently reported adverse events with Protonix Delayed-Release Tablets were headache, diarrhea, and flatulence. Symptomatic response to therapy does not preclude the presence of gastric malignancy. Protonix is contraindicated in patients with known hypersensitivity to any component of the formulation. Patients treated with proton pump inhibitors (PPIs) and warfarin concomitantly should be monitored for increases in INR and prothrombin time.

Source: Wyeth