Santarus Receives FDA Approval for Zegerid Capsules
SAN DIEGO, February 27, 2006 -- Santarus, Inc., a specialty pharmaceutical company focused on therapies for gastrointestinal diseases and disorders, today announced that the U.S. Food and Drug Administration (FDA) has approved the company's New Drug Application (NDA) for Zegerid (omeprazole/sodium bicarbonate) Capsules 40 mg/1100 mg and 20 mg/1100 mg, an immediate-release proton pump inhibitor (PPI). Zegerid Capsules were approved for all of the indications the company was seeking.
"Market approval for Zegerid Capsules is a significant milestone for Santarus, as it is the only immediate-release PPI in a capsule form. Capsules and swallowable tablets constitute the vast majority of the greater than $12 billion U.S. market for prescription PPIs," said Gerald T. Proehl, president and chief executive officer of Santarus. "Therefore, we believe Zegerid Capsules will provide physicians with an immediate-release PPI in their preferred dosage formulation."
Zegerid Capsules are indicated for the treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD), the short-term treatment (four to eight weeks) of erosive esophagitis diagnosed by endoscopy and active benign gastric ulcers, the short-term treatment of active duodenal ulcers and for maintenance of healing of erosive esophagitis (controlled studies do not extend beyond 12 months).
Following the commercial launch of Zegerid Capsules, the Zegerid product line will include the currently marketed Zegerid Powder for Oral Suspension and Zegerid Capsules.
Zegerid offers a distinct pharmacological profile -- rapidly reaching maximal plasma levels (in approximately 30 minutes) and providing strong acid control, with a median 24-hour gastric pH of greater than 4 ranging from 12.2 hours to 18.6 hours depending on the dose and formulation after repeated once-daily dosing. Zegerid Capsules and Powder for Oral Suspension can be conveniently taken once-a-day anytime during the day on an empty stomach, at least one hour before a meal.
PPIs are widely prescribed for a variety of diseases and disorders of the upper digestive tract. All currently marketed oral PPIs, other than Zegerid, are delayed-release formulations that utilize an enteric coating to protect the PPI from acid degradation, delaying absorption and initial acid suppression. Unlike delayed-release PPIs, Zegerid utilizes sodium bicarbonate in lieu of an enteric coating to protect the omeprazole from gastric acid degradation. The sodium bicarbonate buffers the omeprazole and allows for its rapid absorption and suppression of gastric acid.
Important Safety Information
Zegerid (omeprazole/sodium bicarbonate) contains a combination of omeprazole, a PPI, and sodium bicarbonate, an antacid, which raises the gastric pH and thus protects the omeprazole from acid degradation.
The most frequently reported adverse events with Zegerid are headache, diarrhea, and abdominal pain. In critically ill patients treated with Zegerid, adverse events generally reflected the serious, underlying medical condition of the patients, and were similar for patients treated with Zegerid and with the comparator (acid-controlling) drug. Symptomatic response to therapy does not preclude the presence of gastric malignancy. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long term with omeprazole.
Zegerid Capsules contain 300 mg of sodium per dose in the form of sodium bicarbonate (1100 mg/13 mEq), and Zegerid Powder for Oral Suspension contains 460 mg of sodium per dose in the form of sodium bicarbonate (1680 mg/20 mEq). This should be taken into consideration for patients on a sodium-restricted diet. Sodium bicarbonate is contraindicated in patients with metabolic alkalosis and hypocalcemia. Zegerid is contraindicated in patients with known hypersensitivity to any component of the formulation.
Source: Santarus, Inc.
Posted: February 2006