Positive Data From Two Investigator-Initiated Studies With Santarus' ZEGERID To Be Presented At ACG

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Clinical Trials / Drug Trials
Article Date: 26 Oct 2009 - 14:00 PDT

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Santarus, Inc. (NASDAQ: SNTS), a specialty biopharmaceutical company, announced that positive data from two investigator-initiated studies with ZEGERID® (omeprazole/sodium bicarbonate) will be presented in poster sessions at the American College of Gastroenterology (ACG) 2009 Annual Scientific Meeting taking place in San Diego. These studies were supported by grants from Santarus.

Poster P424: Randomized Open-Label Trial to Assess the Impact of Dosage Timing of Omeprazole/Sodium Bicarbonate (Zegerid 40 mg) on Healing of Severe Reflux Esophagitis: Preliminary Results (D Francis, MD, et al) - Monday, October 26, 2009, 10:30 a.m. - 4:00 p.m. Pacific Time

This poster discusses preliminary results from a prospective open-label study with ZEGERID 40 mg administered for 8 weeks, either in the morning before breakfast or at bedtime, in treating subjects with severe erosive esophagitis (LA Grade C and D). For optimal efficacy, proton pump inhibitors (PPIs) are taken on an empty stomach 20 to 60 minutes before a meal, which can be cumbersome. The purpose of the study is to determine if ZEGERID taken at bedtime offers an alternative option for the treatment of severe erosive esophagitis. The goal is to treat 100 subjects (n=50 morning and n=50 bedtime); preliminary data from 46 subjects is reported.

Poster P833: Retrospective Assessment of Immediate-Release Omeprazole/Sodium Bicarbonate in Improvement of GERD Symptoms in Patients Who Failed Delayed-Release Proton Pump Inhibitors (J Jolley, MD) - Tuesday, October 27, 2009, 10:30 a.m. - 4:00 p.m. Pacific Time

This open-label retrospective review of medical records from 50 patients who failed one or more delayed-release proton pump inhibitors (PPIs) evaluated the effectiveness of ZEGERID 40 mg in controlling symptoms of gastroesophageal reflux disease (GERD).

About ZEGERID Prescription Products

ZEGERID (omeprazole/sodium bicarbonate) Capsules and Powder for Oral Suspension are indicated for heartburn and other symptoms associated with GERD, for the short-term treatment of erosive esophagitis diagnosed by endoscopy, for maintenance of healing of erosive esophagitis (controlled studies do not extend beyond 12 months), and for short-term treatment of active benign gastric ulcers and active duodenal ulcers. ZEGERID Powder for Oral Suspension 40 mg is also indicated for the reduction of risk of upper gastrointestinal bleeding in critically ill patients (use beyond 14 days has not been evaluated).

ZEGERID Capsules and Powder for Oral Suspension contain a combination of omeprazole, a PPI, and sodium bicarbonate, an antacid, which raises the gastric pH and thus protects the omeprazole from acid degradation.

ZEGERID products offer a distinct pharmacological profile - rapidly reaching maximal plasma levels (in approximately 30 minutes) and providing strong acid control. While the correlation of pharmacodynamic data to clinical effect has not been established, the median percentage of time gastric pH was greater than 4 over 24 hours in patients treated with ZEGERID in a pharmacodynamic study ranged 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 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 in the U.S., other than ZEGERID, are delayed-release formulations that utilize an enteric coating to protect the PPI from acid degradation, thereby delaying absorption and initial acid suppression. Unlike delayed-release PPIs, ZEGERID Capsules and Powder for Oral Suspension utilize an antacid in lieu of an enteric coating. The antacid neutralizes stomach acid and protects the PPI, omeprazole, from gastric acid degradation and allows for its rapid absorption.

Important Safety Information about ZEGERID Capsules and Powder for Oral Suspension

The most frequently reported adverse events with ZEGERID are headache, diarrhea, and abdominal pain. In 178 critically ill patients treated with ZEGERID Powder for Oral Suspension, adverse events generally reflected the serious, underlying medical condition of the patients, but some adverse events occurred with more frequency in patients treated with ZEGERID Powder for Oral Suspension than in those treated with the comparator (acid-controlling) drug. For more information about these and other events, please see Table 13 of the full Prescribing Information at www.Zegerid.com. 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 304 mg of sodium per dose. ZEGERID Powder for Oral Suspension contains 460 mg of sodium per dose. 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.

Since both 20 mg and 40 mg ZEGERID contain the same amount of sodium bicarbonate (1100 mg in capsules, 1680 mg in packets of powder for oral suspension), two 20 mg capsules are not equivalent to, and should not be substituted for, one 40 mg capsule, and two 20 mg packets are not equivalent to, and should not be substituted for, one 40 mg packet.

Source
Santarus, Inc