FDA Advisory Panel Recommends OTC Status for Heartburn Drug Prilosec

An FDA advisory committee on Friday recommended that Procter & Gamble be allowed to sell AstraZeneca's heartburn treatment Prilosec without a doctor's prescription, the Washington Post reports. The over-the-counter version of the drug -- which would cost about $1 per day -- would be recommended to treat chronic heartburn (Kaufman, Washington Post, 6/22). The prescription version, which costs about $4 per day, would still be recommended for "more serious ailments" such as peptic ulcers and gastroesophageal reflux disease (Freudenheim, New York Times, 6/22). The advisory committee recommended that the OTC version's proposed label be modified to make clear that the medication should be taken "solely for the prevention of heartburn" and not for "acute episodes" (Washington Post, 6/22). The panel also recommended that AstraZeneca and P&G provide "proof that consumers would understand how the drug is to be used" and that consumers only use the treatment two or three times a year for 14 days, as opposed to the traditional regimen of 28 days. The FDA is not bound by but usually follows the recommendations of the committee, which voted 16-2 in favor of OTC status (White, Los Angeles Times, 6/22).

If approved by the FDA, Prilosec would become the first of a group of drugs called proton pump inhibitors to be sold over the counter (Washington Post, 6/22). Last year, the drug had $3.67 billion in U.S. sales for AstraZeneca and is expected to net $200 to $400 million annually if sold without a prescription (New York Times, 6/22). Under a marketing agreement, P&G and AstraZeneca would collect 40% and 60% of Prilosec's profits respectively. In addition, an OTC version of Prilosec could "draw more customers to other AstraZeneca heartburn drugs," including its newly released treatment Nexium, Andrea Hotz, an analyst with Sanford C. Bernstein, said. The OTC approval would also "undercut ... generic competitors," who are "locked in a bitter court fight" over patents for prescription Prilosec and tried to prevent the panel from voting in favor of OTC status, the Los Angeles Times reports (Los Angeles Times, 6/22). OTC Prilosec is expected to compete with Johnson & Johnson's medication Pepcid for the $1.6 billion-a-year OTC heartburn market (New York Times, 6/22). The FDA could make a final decision on Prilosec's status "within the next couple of months," according to Victor Raczkowski, the agency's chief for gastrointestinal disease. A company spokesperson said P&G could begin selling OTC Prilosec by the end of the year (Washington Post, 6/22).