Santarus Receives FDA Approval for Zegerid with Magnesium Hydroxide
Santarus Receives FDA Approval for Zegerid with Magnesium Hydroxide Chewable Tablets
SAN DIEGO, March 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 with Magnesium Hydroxide (omeprazole/sodium bicarbonate/magnesium hydroxide) Chewable Tablets 40 mg/600 mg/700 mg and 20 mg/600 mg/700 mg, an immediate-release proton pump inhibitor (PPI). Zegerid Chewable Tablets were approved for all of the indications the company was seeking.
"This approval is another regulatory milestone for Santarus and is our fourth NDA approved since mid-2004. Each of our NDAs has been approved within the initial 10-month review period under the PDUFA, or Prescription Drug User Fee Act, guidelines, which we believe reflects the capabilities of our clinical, product development and regulatory teams and the overall quality of our submissions," said Gerald T. Proehl, president and chief executive officer of Santarus. "We are evaluating the positioning and launch timing of the chewable tablet dosage form and do not currently anticipate that the commercial launch of this product will occur in 2006. Given the general market preference for the capsule dosage form, our commercial launch plan is based on a strategy intended to maximize our resources, while best positioning Zegerid Capsules for commercial success."
Zegerid Chewable Tablets 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).
The Zegerid family of products, including capsule, powder for oral suspension and chewable tablet dosage forms, offer a distinct pharmacological profile -- rapidly reaching maximal plasma levels (in approximately 30 minutes) and providing 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 strength and dosage form, after repeated once-daily dosing. Zegerid 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, which delays absorption and initial acid suppression. Unlike delayed-release PPIs, Zegerid utilizes one or more antacids in lieu of an enteric coating to protect the omeprazole from gastric acid degradation. The antacids neutralize stomach acid and protect the PPI, omeprazole, from gastric acid degradation and allow for its rapid absorption and suppression of gastric acid.
Important Safety Information
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). The chewable tablet dosage form contains 600 mg (7 mEq) of sodium bicarbonate. This should be taken into consideration for patients on a sodium-restricted diet. Sodium bicarbonate is contraindicated in patients with metabolic alkalosis and hypocalcemia. The chewable tablet dosage form also contains 700 mg (24 mEq) of magnesium hydroxide. The use of magnesium hydroxide is associated with diarrhea, abdominal cramping, chalky taste, diuresis, dehydration, nausea and vomiting. Zegerid is contraindicated in patients with known hypersensitivity to any component of the formulation.
Source: Santarus, Inc.
Posted: March 2006