By John Byczkowski
The Cincinnati Enquirer

The Food and Drug Administration has approved the heartburn drug Prilosec for over-the-counter sales.

Heartburn sufferers and Procter & Gamble Co. both got relief late Friday, as the Food and Drug Administration approved Prilosec for over-the-counter sale.

Prilosec is one of the world's most-prescribed drugs, with twice as many users as the popular anti-allergy drug Claritin. It could develop into a business worth $200 million or more in annual sales for P&G, which holds marketing and distribution rights to the drug.

The FDA, however, approved Prilosec for over-the-counter sale only as a treatment for frequent heartburn. It was not approved for sale as an after-meal heartburn remedy or as a before-meal heartburn preventative. The FDA's approval came only after P&G conducted research to demonstrate consumers would understand these limitations.

Still, the approval is a big victory for P&G. Chief executive A.G. Lafley, has targeted growth in health care to boost the company's sales, profits and stock price.

"For 40 million consumers who've been searching for a way to treat their frequent heartburn, this is a huge win," said Joe Arcuri, general manager of P&G's personal health-care businesses.

Though sale of the drug won't begin till October, P&G will begin marketing it immediately. The push will begin in 24 cities with the most heartburn, as identified by the National Heartburn Alliance. Cincinnati is one of those cities.

P&G stock rose 82 cents a share to $91.23 Friday, in anticipation of Prilosec's approval.

After sales of Prilosec start this fall, P&G hopes to get $200 million to $400 million in annual sales, and will pay undisclosed royalties to AstraZeneca, which makes Prilosec. Arcuri declined to say what Prilosec would mean to the company's profits.

The cost will go down to less than $1 per pill, about one-quarter of the prescription cost but possibly more than the co-payment many customers with insurance pay now.

"I think people will be snatching this up," said Dr. Thomas Grimm, who runs a family medicine practice in Kenwood. "... A lot of people have been asking for it by name. They know it."

Prilosec, widely known as the "purple pill," would be the first in a family of drugs to go over-the-counter that actually treat the "pump" that sends acids into the stomach, causing heartburn.

With the shift to over-the-counter, the drug will become a pink tablet but packaging will be purple. Each packet will have 14 pills.

Other types of the $1.2 billion anti-heartburn market are led by Pepcid, marketed by a joint venture of Merck & Co. and Johnson & Johnson. Officials there said Prilosec can take up to three days to work, while consumers can take Pepcid after they start experience "episodic" heartburn.

P&G originally sought approval for sale of Prilosec for prevention and relief of heartburn. But the FDA rejected two claims. First, "the product is just not very effective for immediate relief of heartburn," said Dr. Charles Ganley, director of the FDA's division of over-the-counter products.

Second, he said, it's also not very effective in preventing a one-time event of heartburn, for instance, if someone is about to sit down to a big meal and wants to prevent heartburn afterward.

But Prilosec is effective "as a course of therapy" for people who have heartburn two or more times a week, and they shouldn't take a 14-day course of the drug more than once every four months without seeing a doctor. Dr. Ganley said the risk is that consumers might have a problem worse than heartburn.

To prove consumers would understand this distinction, P&G tested product labeling on 1,800 people in 45 cities. The FDA approved the labeling, leading to Friday's announcement.

Staff writer Cliff Peale contributed, as did the New York Times and Bloomberg News.

E-mail johnb@enquirer.com