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| |  Advisory Committee Confirms Over-The-Counter Safety And Efficacy Of Prilosec (Omeprazole) For Heartburn CINCINNATI, OH and WILMINGTON, DE -- October 23, 2000 -- A joint session of the Nonprescription Drugs Advisory Committee and Gastroenterological Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) recommended that Prilosec® (omeprazole), the world's top-selling drug, can be safe and effective as an over-the-counter (OTC) preventative treatment for heartburn, according to Procter & Gamble and AstraZeneca. The joint committees requested additional data. The committee based its discussions on the results of OTC clinical trials involving more than 11,000 patients. Available worldwide as a prescription medicine for more than a decade, Prilosec has been used in more than 400 million patient treatments and studied in more than 1,350 clinical trials. "We are encouraged by the outcome of today's meeting. It's quite common for the committee to request additional data for a first-in-class Rx-to-OTC switch," says Tom Blinn, vice president of OTC healthcare at Procter & Gamble, which will be marketing and distributing the drug in the U.S. "We will work closely with the FDA to provide the data requested." More than 50 million Americans -- or 40 percent of the adult population -- suffer from heartburn. A variety of dietary and lifestyle factors such as spicy foods or stress can contribute to heartburn and can negatively impact normal activities and sleep. Current OTC therapies include antacids, which are indicated for temporary relief of heartburn, and H2 blockers, which are indicated for relief of heartburn and prevention of heartburn associated with food and beverage. Antacids neutralize stomach acid with relief lasting up to three hours, while H2 blockers may reduce acid production for up to 12 hours. Prilosec belongs to a unique class of drugs called proton pump inhibitors (PPIs) currently available only by prescription. PPIs like Prilosec deactivate the acid pumps to significantly reduce acid secretion for up to 24 hours. "We believe that an OTC version of Prilosec will provide consumers with the possibility of up to 24-hour heartburn prevention with just one pill," says Mark Mallon, vice president, gastrointestinal therapeutic area, AstraZeneca. Prescription Prilosec, marketed globally by AstraZeneca, is indicated for several different uses encompassing a broad range of acid-related gastrointestinal diseases, including heartburn and other symptoms associated with gastroesophageal reflux disease. Individual results may vary. The most common side effects of prescription Prilosec are headache, diarrhea and abdominal pain. Related Links: Prilosec (omeprazole), Procter & Gamble and AstraZeneca.
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