P&G challenges Schering Plough’s claim on proton-pump inhibitor


CINCINNATI Procter & Gamble last month challenged Schering Plough’s ability to market its pending switch of the proton-pump inhibitor Zegerid as “immediate release,” arguing that the term is likely to be confused with “immediate relief” among lay consumers.

“Consumers, without the benefit of physician supervision, will likely interpret ‘immediate release’ as synonymous with ‘immediate relief,’” P&G argued in a Nov. 17 Citizen’s Petition filed with the Food and Drug Administration. “Not only do ‘release’ and ‘relief’ sound strikingly alike, but they have similar implications to consumers in the OTC drug context.”

In support of its Citizen’s Petition, P&G commissioned an online survey of 1,000 consumers, including 214 who were identified as frequent heartburn sufferers. As many as 65 percent of those frequent sufferers associated “immediate release” with speed of relief, P&G said. As many as 74 percent of the frequent sufferers indicated they would prefer an immediate release product over a delayed release product, suggesting that the majority of consumers may choose a Zegerid OTC product touting “immediate release” over Prilosec OTC or store brand omeprazole if Zegerid is approved for sale over-the-counter.

More than 89 percent of those frequent sufferers expected any “immediate release” product to provide symptomatic relief within 30 minutes.

Zegerid contains sodium bicarbonate in addition to the PPI omeprazole, which Santarus claims helps neutralize stomach acid and speeds absorption of the omeprazole within 30 minutes. However, P&G challenges that even with speedier absorption, the omeprazole active could take between one and four days before providing symptomatic heartburn relief. When Prilosec OTC was approved for switch, P&G noted, FDA required the marketer to include in its labeling: “Not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect.”

On zegerid.com, Santarus claims: “Except for Zegerid, all proton pump inhibitors are delayed-release acid reflux drugs. Delayed-release proton pump inhibitors use a coating, called an enteric coating, to protect the acid reflux medicine from acid degradation while passing through the stomach. This coating delays the acid reflux medicine from getting into the bloodstream. Zegerid does not have an enteric coating and the acid reflux medicine is rapidly absorbed into the bloodstream. That’s why Zegerid is the first and only immediate-release oral proton pump inhibitor.”

Approximately 276,000 prescriptions for Zegerid were filled in the third quarter of 2008, Santarus reported, an increase of 20 percent versus total prescriptions in the year-ago period. That corresponded to sales of $28.1 million for the quarter, up 44 percent.

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