FDA's June 20 approval of Procter & Gamble/ AstraZeneca's Prilosec OTC permits the companies to sell the proton pump inhibitor in packages containing more than one 14-day treatment regimen.

The agency's ¹ approval letter for NDA 21-229 notes FDA is "approving 28- and 42-count package sizes for this product amid concerns that consumers follow instructions that limit duration of use to 14 consecutive days and frequency of use to not more than three courses in a given year."

"If you recall, much of the discussion of the June 2002 joint meeting of the Nonprescription and Gastrointestinal Drugs Advisory Committees focused on the issue of appropriate duration and frequency of use," the letter continues.

"The joint committees recommended a course of therapy no longer than 14 consecutive days and no more than three courses per year, and we have followed these recommendations."

"By proposing these 28- and 42-count package sizes configured as multiple 14-count units, we feel that consumers may better understand the limitations of use," FDA says.

"However, if you should be interested in marketing other package configurations in the future (e.g., bottles containing greater than 14 capsules)," the agency notes it "will expect submission of a prior approval supplement that includes data to adequately demonstrate appropriate consumer comprehension of the limitations of use."

The June 20 letter also contains FDA's approval of a 14-count package and 2-count trial sample sizes. The agency notes it received P&G/AstraZeneca's NDA on Jan. 27, 2000, which was followed by five additional submissions.

At their June 2002 review of Prilosec's switch NDA, members of both NDAC and GDAC urged FDA to require labeling to state consumers should not take a 14-day regimen of Prilosec more than three times per year. The committees also expressed concern about whether labeling could adequately convey to consumers that Prilosec is for heartburn prevention, not treatment, and that the drug should be taken for only 14 days regardless of whether symptoms persist (² Also see "Annual Use Limitations For Prilosec 1 Should Appear In Labeling – NDAC/GDAC" - Pink Sheet, 1 July, 2002., p. 10).

However, the committees voted 16-2 in favor of allowing the drug to switch OTC despite the concerns (³ Also see "Prilosec 1 Use For GERD Endorsed In 16-2 Joint Committee Vote" - Pink Sheet, 24 June, 2002., p. 3).

The "Directions" section of Prilosec OTC's ⁴ approved 'Drug Facts' labeling states: "adults 18 years of age and older [bullet] this product is to be used once a day (every 24 hours), every day for 14 days [bullet] it may take one to four days for full effect, although some people get complete relief of symptoms within 24 hours."

Under the heading "Repeated 14-Day Courses (if needed)," labeling reads: "you may repeat a 14-day course every four months [bullet] do not take for more than 14 days or more often than every four months unless directed by a doctor."

The "Uses" section states Prilosec OTC "treats frequent heartburn (occurs two or more days a week)" and adds it is "not intended for immediate relief of heartburn."

The approved labeling may answer some of the committees' concerns, as it was subjected to a label comprehension study conducted after the advisory committee meeting. Completing the study was one of the last steps to receiving agency approval for the drug; FDA designated it "approvable" in August 2002 (⁵ 'The Tan Sheet' Aug. 26, 2002, In Brief).

A June 20 ⁶ FDA press release also notes "FDA based its approval...on the results of various studies, including two clinical studies. These...studies demonstrated that Prilosec OTC was effective in increasing the proportion of patients with no heartburn over 24 hours and that the effectiveness of Prilosec OTC increases from day 1 to day 14."

Other sections of the product's labeling advise consumers to consult a doctor if they are taking warfarin, an Rx antifungal or anti-yeast medication, diazepam or digoxin.

Labeling also notes consumers should consult their physician if: their "heartburn continues or worsens"; "you need to take this product for more than 14 days"; or "you need to take more than one course of treatment every four months."

While much of Prilosec OTC's approved labeling seeks to differentiate the proton pump inhibitor from currently marketed heartburn remedies, the drug's package insert also takes similar steps.

The insert notes Prilosec OTC "works differently from other OTC heartburn products, such as antacids and other acid reducers...Prilosec OTC is not intended for those who have heartburn infrequently, one episode of heartburn a week or less, or for those who want immediate relief of heartburn."

P&G said it plans to launch Prilosec OTC, which contains 20 mg omeprazole magnesium in a delayed-release tablet, in the fall.

Unlike the Rx version's purple pill, Prilosec OTC will come in a salmon-colored tablet. P&G said the color change is due to the fact the product will be in tablet, not capsule, form. Packaging for the proton pump inhibitor will remain purple, though.

P&G also plans to promote the product with "The BurnTown Challenge." An educational initiative in partnership with the American Pharmacists Association and National Heartburn Alliance, the challenge will provide 1,000 people in 24 cities with a free 14-day Prilosec OTC regimen, as well as offer free heartburn screenings and lifestyle modification tips to attendees.

The product will provide a huge boost to P&G's healthcare sales. According to FDA's release, the agency awarded P&G/AstraZeneca three years of Hatch/Waxman marketing exclusivity.

The heartburn remedy also will face stiff competition once it launches. For example, GlaxoSmithKline plans to launch a new product in its Tums line of antacids in September (see story, p. 7).

Besides helping P&G's financial results, the Prilosec OTC approval also could help the finances of consumers.

Reflecting his economic background, FDA Commissioner Mark McClellan, MD/PhD, stated in the agency's release that the "availability of Prilosec OTC will help reduce costs and expand the availability of treatment options for millions of Americans."

The "approval of [OTC] Prilosec 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," he added.

Prilosec OTC Approved In 28-, 42-Count Multiple Regimen Sizes

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