In the OTC drug market, the right claims can be crucial to competing in crowded categories. Procter & Gamble had a big hit with the first-in-class Rx-to-OTC switch of the proton pump inhibitor Prilosec OTC (omeprazole). But with private label competition eroding market share since earlier this year, P&G is hoping to block certain competitive claims from Schering-Plough's expected OTC switch of Santarus' Zegerid, an immediate release formulation that combines omeprazole with sodium bicarbonate for more rapid absorption. In fact, if you say "immediate release" around any lawyers from P&G, enunciate clearly: in a petition to FDA intended to limit certain claims for Zegerid, P&G says consumers are likely to be misled by the phrase, confusing "immediate release" with "immediate relief." But one consultant thinks the petition won't hold water, and says that sponsors should be able to win some kind of rapid onset claim from FDA. The Tan Sheet, in an exclusive analysis, takes a close look at the petition and its chances.
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P&G Says Zegerid Switch Proposal Should Drop “Immediate Release” Claim
The proton pump inhibitor Zegerid should not be allowed on the over-the-counter market with the label claim "immediate release," says Prilosec OTC marketer Procter & Gamble.
In a citizen petition submitted Nov. 17, P&G asks FDA not to approve an OTC version of Zegerid (omeprazole/sodium bicarbonate) with "misleading" labeling that could cause consumers to believe the PPI will provide "immediate relief" for heartburn...
In March, Schering-Plough announced it filed a new drug application to market Zegerid OTC, under a licensing agreement with Santarus. San Diego-based Santarus says the OTC product could receive approval and be on shelves in early 2009.
The petition is an attempt by P&G to blunt the edge Zegerid could have if FDA allows claims of a more rapid onset than delayed-release PPIs.
P&G presents data it says show that consumers would select OTC Zegerid over competitors under the false impression that "immediate release" delivery is synonymous with "immediate relief."
A survey P&G commissioned showed 65 percent of frequent heartburn sufferers equated release with relief, and 74 percent said they preferred immediate release over delayed release in a drug.
Prilosec OTC sales saw a double-digit drop in the first quarter of 2009, caused in part by competition from private-label equivalents introduced after P&G's loss of exclusivity in March.
P&G also says OTC Zegerid should not highlight the antacid sodium bicarbonate as an active ingredient because consumers could "erroneously conclude that the product is therefore more effective than other similar single-entity products."
FDA characterized the sodium bicarbonate in prescription Zegerid as an active excipient that contributes to the delivery of omeprazole, rather than a distinct active ingredient, P&G notes.
In a declaration P&G submitted with its petition, David A. Peura, a gastroenterologist and emeritus professor of medicine at University of Virginia, voices concern about OTC use of Zegerid if it is pitched as an immediate release product.
Reference to immediate release or the presence of an antacid in the formulation could lead consumers to take the product for episodic relief of heartburn symptoms, rather than for the presumed indication of a single daily dose for heartburn prevention and treatment, Peura says.
"If by chance the consumer should experience some level of temporary relief due to the acid buffering effect of sodium bicarbonate, it could result in the consumer misusing the product" and exceeding the recommended single daily dose, Peura says.
Gastroenterologist Thomas Garvey, a former supervisory medical officer in FDA's Center for Drug Evaluation and Research, called the safety issue in the petition "an invented problem" intended to pose a "nuisance" to the switch process.
Garvey served as a consultant to P&G, prior to the Prilosec OTC launch, and to Santarus. He is president of Garvey Associates in Potomac, Md.
Garvey noted it is likely that Santarus has asked for a rapid onset of relief indication.
"Certainly, the acid suppression associated with Zegerid is faster than with a standard enteric-coated omeprazole formulation," he said.
If FDA grants rapid onset claims, Zegerid could still have a competitive advantage, whether an "immediate release" claim is allowed or not.
Garvey said P&G demonstrates no evidence to counter the clean safety record for PPIs and needlessly requests comprehension and actual use studies that have likely already been completed.
"Procter has got OTC omeprazole and they're sort of obligated, in a sense, to fuss," said Garvey.
Santarus and S-P both declined to comment on P&G's petition.
An FDA spokeswoman said the agency will respond to P&G's petition within 180 days.
- Dan Schiff (d.schiff@elsevier.com)
