Prilosec Goes OTC
June 23, 2003 – NEW YORK (Reuters) - Popular heartburn drug Prilosec received U.S. Food and Drug Administration clearance on Friday to be sold without a prescription, opening the way for a planned fall launch of the blockbuster heartburn drug by Procter & Gamble Co., the company said.

The approval comes after P&G, which holds the over-the-counter rights to drug, made changes to the labeling on the box at the behest of the FDA, so consumers could better understand when and how to take the drug, which will be called Prilosec OTC.
Prilosec enters the $1.2 billion over-the-counter U.S. acid relief market where acid-reducer Pepcid is currently the market leader. It will come in the form of 20 mg tablets, the most commonly prescribed strength of the drug.

P&G has an agreement to market the drug over the counter with the drug's maker, AstraZeneca Plc, and has said it expects to sell $200 million to $400 million in the first year the drug is available over the counter. Greg Allgood, associate director of P&G Health Sciences Institute, said that level of sales would make Prilosec OTC the "market leader in the heartburn aisle" and one of the largest over-the-counter switches ever.

The consumer products maker, better known for its Tide laundry detergent and Crest toothpaste, hopes to start selling the drug in the fall for less than $1 per tablet, compared with more than the $4 per capsule AstraZeneca charges on a prescription basis.

For consumers, the approval of OTC Prilosec means they can get the heartburn drug without first going to the doctor. But Prilosec OTC could cost more for some people who once paid a small co-payment under their insurance plan.

Prilosec, which is the first proton pump inhibitor drug to go over-the-counter, was once the world's top-selling drug, regularly logging more than $6 billion in annual sales.
With the patent for Prilosec set to expire in late 2001, AstraZeneca devoted its marketing efforts to its new prescription "purple pill," Nexium, to preserve its franchise in prescription heartburn treatments.

AstraZeneca was able to fend off most generic competitors to Prilosec in court and now faces only Schwarz Pharma AG in the U.S. market. But as a result of the competition and the shift in marketing to Nexium, Prilosec sales slipped to $4.6 billion last year from $5.6 billion in 2001.

Pepcid, marketed by Johnson & Johnson and Merck, is likely to promote its ability to be taken every day versus Prilosec where consumers are advised not to take a 14-day course more often than every four months for frequent heartburn unless directed by a doctor.

An estimated 61 million Americans suffer heartburn at least once a month. "Consumers can safely treat themselves -- if they need to -- every day," Kathy Widmer, director of marketing for Johnson & Johnson, told Reuters.

Doctors have expressed concern that making Prilosec available without a prescription could be dangerous because patients may treat themselves for heartburn, not realizing they have more serious problems such as Barrett's esophagus, a constant irritation of the esophagus by gastric juices that can lead to cancer.

Dr. Charles Ganley, director of division of OTC drugs at FDA, noted that the drug is meant to be taken for a full two weeks, unlike current retail heartburn medications. Ganley said Procter & Gamble had to work on the Prilosec OTC's labeling so customers would understand that they should see a doctor if symptoms occur again after 14 days of using the drug.

Note: Dr. Hansen recommends Pepteal, a combination of Licorice root, Aloe vera, and Quercitin in stead of the acid blocking drugs that don’t fix the problem. For more information about Pepteal, click here.