FDA Approves Santarus’ Zegerid As First PPI Immediate-Release Capsule
This article was originally published in The Pink Sheet Daily
Executive Summary
The company will highlight rapid absorption of Zegerid capsules over available delayed-release PPIs.
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Santarus is highlighting the rapid absorption of its immediate-release proton pump inhibitor capsule Zegerid (omeprazole) over other PPIs in its class. FDA's Feb. 27 approval of Zegerid's new formulation makes it "the only immediate-release proton pump inhibitor (PPI) in a capsule form," Santarus said in a release. Omeprazole is also available in 10 mg, 20 mg and 40 mg delayed-release capsules (AstraZeneca's Prilosec and generics). "All currently marketed oral PPIs, other than Zegerid...utilize an enteric coating to protect the PPI from acid degradation, delaying absorption and initial acid suppression," Santarus said. "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." Santarus said it will promote Zegerid capsules with its existing 200-person sales force and marketing partner Otsuka's 170 sales professionals. The company will likely discuss a launch date for Zegerid capsules during an upcoming March 6 earnings call for fourth quarter and full year 2005 financial results. Zegerid capsules, a combination PPI and antacid, consist of 300 mg of sodium per dose in the form of sodium bicarbonate (1100 mg/13 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," the company warned. Available in 40 mg/1100 mg and 20 mg/1100 mg doses, Zegerid is indicated for the treatment of heartburn and symptoms associated with gastroesophageal reflux disease, as well as the short-term treatment (four to eight weeks) of erosive esophagitis, gastric ulcers and duodenal ulcers. The company submitted its NDA for the immediate-release capsule formulation of omeprazole under a 505(b)(2) in April 27, 2005. Santarus already markets 20 mg and 40 mg doses of immediate-release omeprazole powder for oral suspension. The 40 mg oral suspension is the only FDA-approved PPI for reduction of risk of upper GI bleeding in critically ill patients (1 (Also see "Proton Pump Inhibitors Could Get Boost From COX-2 Concerns OF FDA Cmte." - Pink Sheet, 22 Feb, 2005.)). Another application for an immediate-release chewable tablet formulation is currently under review at FDA and has a user fee date of March 26. "Capsules and swallowable tablets constitute the vast majority of the greater than $12 bil. U.S. market for prescription PPIs," Santarus said. TAP's Prevacid (lansoprazole), a 40 mg delayed-release formulation, is currently the only proton pump inhibitor sold as a suspension. Prevacid is also available in delayed-release capsules and orally disintegrating tablets. Wyeth's Protonix (pantoprazole) is available in injectable and tablet forms, while AstraZeneca's Prilosec follow-on product Nexium (esomeprazole) and Johnson & Johnson/Eisai's Aciphex (rabeprazole) are sold in delayed-release tablets. The heightened concerns over the cardiovascular safety of the COX-2 inhibitor class could provide a boost for Zegerid and the overall PPI market (2 (Also see "COX-2 Cardio Risk Is Class Effect, But Varies By Drug And Dose, Cmte. Says" - Pink Sheet, 18 Feb, 2005.)). -Turna Ray |