Santarus, Inc., a specialty pharmaceutical company, has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for a new tablet formulation to add to its Zegerid family of branded prescription pharmaceutical products. The new formulation is an immediate-release tablet that combines omeprazole, a proton pump inhibitor (PPI), with a mix of buffers. The company's objective is to have the new Zegerid tablet product commercially available in the US in the fourth quarter of 2009.
The NDA was submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. If the NDA is accepted for filing by the FDA, Santarus will provide notice to the NDA holder for Prilosec (delayed-release omeprazole capsules) and related patent holders that the new tablet formulation does not infringe the patents listed in the Orange Book for Prilosec or that those patents are invalid.
Zegerid (omeprazole/sodium bicarbonate) capsules and powder for oral suspension are indicated for the treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD), maintenance of healing and short-term treatment of erosive esophagitis, and 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.
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 US, 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 and suppression of gastric acid.
Santarus, Inc. is a specialty pharmaceutical company focused on acquiring, developing and commercializing proprietary prescription products that address the needs of patients treated by gastroenterologists and other targeted physicians.