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news.The FDA has given its go-ahead for Santarus to market a new capsule formulation of Zegerid, its immediate-release proton pump inhibitor indicated for the treatment of various gastrointestinal disorders. The drug is already marketed as a powder for oral suspension.
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“Market approval for Zegerid Capsules is a significant milestone for Santarus, as it is the only immediate-release PPI (proton pump inhibitor) in a capsule form. Capsules and swallowable tablets constitute the vast majority of the greater than $12 billion US market for prescription PPIs,” said Gerald Proehl, president and CEO of Santarus.
Zegerid is 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.
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.