Delsym

It should be a good time for sellers of over-the-counter remedies. In the past few years, two pharmaceutical blockbusters have switched from their prescription-only roots for sale OTC. Schering-Plough's Claritin franchise generated $230.9 million across two SKUs in sales throughout food, drug and mass (excluding Wal-Mart) for the 52 weeks ended March 20, according to Information Resources Inc., while Procter & Gamble's Prilosec OTC pulled in $243.8 million in that time period, with 89 percent growth.

And with the increasing focus on containing the overall cost of health care, the inherent savings afforded by self-treating should only drive more business toward OTC aisles. The graying of America has been credited for an increase in the sales of arthritis treatments, external rubs and adult incontinence products.

And yet, the following year may provide as many pitfalls as it does opportunities, with safety concerns surrounding both the chronic use of nonprescription nonsteroidal anti-inflammatory drugs and high doses of the dietary supplement vitamin E affecting consumer perception.

But perhaps no one event will have as much of an impact on the future of the OTC business as the sweeping move by several national retailers to move products containing the ingredient pseudoephedrine off store shelves and behind the pharmacy counter. The move is being made because pseudoephedrine is a key ingredient used to produce crystal methamphetamine illegally. Still, consumers are expected to continue shopping the cough-cold aisle rather than walking to the pharmacy counter and logging a decongestant purchase into a registry maintained by pharmacy personnel, as some states may require.

The potential impact may well eclipse the sudden recall in late 2000 of products containing phenylpropanolamine. Of the top 10 cough-cold products sold in drug stores in the past year through March 20, six contain pseudoephedrine, making up 49 percent of the $391 million in sales those 10 products represent, according to Information Resources Inc.

The bad news is that cough-cold sales across the spectrum are expected to drop, weighed down by the anticipated declining volume of pseudoephedrine products. The good news for those products not containing pseudoephedrine will be a sales boost. Hence, the mad dash by a host of suppliers to reformulate their entire product lines with phenylephrine.

ANALGESICS

Across the aisle in the analgesics section, sales of arthritis remedies were expected to increase dramatically following the withdrawal last fall of the cox-2 inhibitor Vioxx because of its link to increased heart disease and the subsequent concern that fellow cox-2 inhibitors Bextra and Celebrex carried similar risks. And while sales of pain relievers marketed against arthritis certainly did get a significant lift--sales of Tylenol Arthritis climbed 14.4 percent in the drug channel to $27.2 million, according to IRI--it was not as dramatic as anticipated. A significant portion of consumers were assumed to have suffered through their pain until the dust surrounding the safety concerns settled.

Now that it has, it appears that nonprescription NSAIDs, such as the naproxen sodium found in Aleve, have regained a bit of their safe reputation following the February meeting of the Food and Drug Administration's Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee.

Thus, consumers are expected to consult their doctors and pharmacists regarding the best course of therapy for treating arthritis pain, and that may include a regimen of glucosamine/chondroitin or an NSAID taken under a doctor's direction, which could provide a boost to two categories that experienced a slight drop in sales in the past year. Sales of internal analgesics tablets in the drug channel dropped 1.5 percent for the 52 weeks ended March 20, representing a loss of $13.5 million. Meanwhile, sales of glucosamine/chondroitin dropped 3.5 percent, a $6.5 million loss.

Of course, with the increased use of NSAIDs, there also may be a greater need for heartburn remedies going forward. Sales of Prilosec OTC grew 87 percent to $135.3 million in chain drug for the 52 weeks ended March 20, according to IRI, and that's after incorporating the significant supply chain challenges P&G experienced in filling those Prilosec OTC orders. Armed with a track record of product demand, P&G is expected to capitalize on those missed sales opportunities in the coming year.

Meanwhile, Johnson & Johnson's Pepcid heartburn-relief franchise continues to perform well, thanks in no small part to the introduction of Maximum Strength Pepcid AC around the time Prilosec OTC launched. Pfizer hopes to duplicate J&J's success with its FDA approval of Zantac 150, a higher-strength H-2 blocker launched in January.

Sales of individual vitamin E SKUs dropped by as much as 40 percent last fall in the wake of Johns Hopkins University's Dr. Edgar Miller's conclusion that high doses of vitamin E--400 International Units or more--were linked to an increase in mortality rates, according to a meta-analysis of 19 vitamin E clinical trials. Proponents of vitamin E charged that the study was flawed, as it only incorporated select trials studying population groups predisposed to increased mortality rates (i.e., the elderly). Yet, however flawed it might have been, the release of the report was followed by a separate study conducted over a seven-year period and published in the March Journal of the American Medical Association. The new study found no reduction in cancer risk or cardiovascular events with the daily supplement usage of 400 IUs of vitamin E, but did find a potential increase in risk of heart failure.

WEIGHT LOSS

Weight loss is one category that ought to experience significant traffic throughout the next year. Consumers still find the option of weight loss in a bottle appealing, even after the FDA banned the maligned herbal ingredient ephedra from store shelves last year. Trim Spa's marketing campaign featuring a slimmed-down Anna Nicole Smith has moved the brand to the top of the diet tablet charts, with sales of $28.3 million in drug stores, representing growth of 25.7 percent for the 52 weeks ended March 20, according to IRI.

Once king of the diet aid tablet mountain, two non-ephedra Metabolife SKUs pulled in $14.9 million between them, showing that the brand has survived despite any ephedra-related stigma.

Of course, ephedra could make a comeback this year. Neutraceutical last month won its suit against the FDA, overturning the agency's ban on ephedra 10 mg, potentially paving the way for a reintroduction.

In another move that could bring new life to the OTC diet category, GlaxoSmithKline is moving forward with its application to switch Orlistat, a prescription drug marketed against obesity. Should Orlistat gain OTC status, it would be the first time an OTC medicine would be indicated for weight loss since PPA was pulled off shelves in 2000.

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