AstraZeneca/P&G's Prilosec OTC cleared by FDA for frequent heartburn

The US Food and Drug Administration has approved AstraZeneca's proton pump inhibitor antiulcerant Prilosec (omeprazole) as the first over-the-counter treatment for frequent heartburn. The OTC version will be marketed in the USA by Procter & Gamble, in a 20mg dose, and is scheduled for launch this fall.

AstraZeneca has been trying for several years to get OTC status for Prilosec, which is now off patent in the USA, to help protect its franchise. However, observers believe this version could canabalize the firm's follow on drug, Nexium (esomeprazole), which remains patent-protected for the treatment of heartburn associated with gastroesophageal reflux disease and other acid-related conditions.

Prilosec OTC is the only non-prescription therapy specifically indicated for the treatment of frequent heartburn, a condition described by the FDA as hearburn that occurs two or more days per week. FDA Commissioner Mark McClellan said this approval "is yet another example of the important role FDA serves in improving access to safe and effective treatments for conditions that people can treat themselves." The OTC product is not for use in people who have infrequent, one episode or less a week, the agency stipulated, noting that over 60 million Americans experience heartburn at least once a month and that some studies have suggested 15 million US citizens suffer the condition daily.