Rx-to-OTC Switches Drive Growth

The OTC market was solid in 2006 and will continue to be a source of growth for pharmacies. ?Growing government and societal emphasis on self-medication results in a boost for OTC medications,? said Brian Morgan, research analyst for Euromonitor International. Morgan said the trend toward self-medication is expected to gain momentum as the country begins to grapple with the fiscal realities of paying for the health needs of an aging baby boom population. ?OTC health care remedies may eventually see rising sales as health care costs in the United States increase and both government-funded health care and private health care providers seek ways to contain costs and shift the burden of increased needs in health care back to the individual consumers,? said Morgan.

As pharmacists see more and more new OTC drugs enter the market, they can expect to spend an increasing amount of time counseling their patients on OTCs. Many of the key introductions this year have been Rx-to-OTC switches?products that often generate questions from patients.

Big Year for Switches

?Within the past 14 months, we have seen 5 switches, not necessarily being the most switches from Rx to OTC in a year, but this volume in such a short time does approach the high-water mark in terms of Rx-to-OTC switches,? said Elizabeth Funderburk, a spokesperson for the Consumer Health Products Association.

?After a year with virtually no switches, we went to a year with several, and that is news,? said Bruce Carlson, associate publisher at Kalorama Information.

Switched products often become category leaders. ?The 3 OTC brands that represent almost one third of dollar sales growth in 2006 were Rx-to-OTC switches,? said Bob Doyle, senior vice president of Information Resource Inc?s (IRI) Healthcare Solutions Group.

One of the most exciting switches came in March 2007 with Schering-Plough Corp?s switch of the laxative MiraLAX (polyethylene glycol 3350). The product is the first Rx-to-OTC switch in the laxative category in 30 years.

?MiraLAX was number 1 in the prescription category until it faced generic competition in 2004, but generic competition is not a threat in the OTC market for 3 years, so Schering-Plough has a great opportunity here to take back the laxative market,? said Melissa Elder, Kalorama Information analyst and author of The Market for Rx-to-OTC Switches.

Laxatives represent a segment with potential in the gastrointestinal category?1 in 4 Amer-icans suffer from occasional constipation. The gastrointestinal category in general has grown every year between 2001 and 2006, according to Mintel Research. Mintel analysts predict that the increasing number of older patients represents a potentially healthy market for the category for some time. The category is among the top 3 categories in terms of independent drugstore sales, according to the Hamacher Resource Group.

Amy Kasza, a Hamacher analyst, believes future action in the category will come from pro-biotic and prebiotic products, which help restore digestive balance naturally. ?Probiotic manufacturers are gearing up to enter more products into the antacid/laxative category,? she said.

An Eye Drop Switch

The cough/cold/allergy category received a boost from the switch of Novartis? Zaditor antihistamine eye drops (ketotifen fumarate ophthalmic solution 0.025%) in the fourth quarter of 2006. The drops provide 12 hours of relief in a single drop.

Alimera Sciences Inc, a 3-year-old ophthalmic pharmaceutical company, also was granted FDA approval to market a competing product, Alaway. That product is now available and is being marketed by Bausch & Lomb. The eye care category showed year-on-year growth of nearly 5%, according to Euromonitor data.

The market for allergy OTCs has remained strong?particularly since the incidence of allergies has been steadily rising for the past 3 or 4 decades, according to the American College of

Allergy, Asthma and Immunology. New OTCs providing improved or longer-lasting treatment always make a mark on the category.

Industry analysts expect switched antihistamines/allergy remedies to generate major product developments in the cough/cold/allergy category in the next few years. Another area for growth is likely to come from child-specific cough/cold/allergy remedies due to growing demand from the ?echo boom? generation, increased evidence of allergies among children, and an increase in parents self-medicating children for these conditions.

Sunscreen Grows in Importance

Another key switch was the prescription sun-screen Anthelios SX (ecamsule)?a product that should make an impact in an increasingly important category. Ecamsule, a new molecular entity, is combined with avobenzone and octocrylene in this sunscreen that is touted as having the highest protection against UVA rays?which experts say are the number-1 cause of skin aging.

The switch marks the first time since 1988 that the FDA has approved a new sunscreen. Anthelios SX has been available in Europe without a prescription and has been highly successful. La Roche-Posay is marketing the US product, Anthelios SX Daily Moisturizing Cream with Mexoryl SX.

Sunscreens have grown in importance as patients recognize the dangers of unprotected exposure to the sun. ?The trend for sunscreens is definitely on the upswing,? said IRI?s Doyle.

Plan B, Alli Create Waves

In August 2006, the FDA also approved Barr Pharmaceuticals? Plan B. ?Plan B was available nationwide as of December 2006 and costs anywhere between $30 and $60,? said Kalorama?s Elder. Some pharmacies declined to carry the product for moral reasons, but in most cases, pharmacies are offering the product and developing procedures for selling the ?dual-status? drug, since it is available on an OTC basis only to women aged 18 and older. ?We believe that

Plan B has created a precedent and has prepared the pharmacy for infrastructure for future products,? said Elder.

IRI?s Doyle said that Plan B?s approval, the move to keep pseudoephedrine behind the counter, and FDA Commissioner Andrew C. von Eschenbach?s recent comments in support of the creation of a third class of drugs contribute to an environment hospitable to creating a new classification for OTCs.

Analysts also are watching GlaxoSmithKline?s recently switched weight-loss drug orlistat, which received OTC approval in February. The OTC version, alli, is available in a half dose (60 mg) of the prescription dose. The rising rate of obesity could make the drug a blockbuster. Said Hamacher?s Kasza, ?alli is going to rock the weight-management category.? Future switches to watch will be Pfizer?s allergy medication Zyrtec, which is likely to see a switch in 2007, and TAP Pharmaceuticals? proton pump inhibitor Prevacid, which is up for a switch in 2008.

Ms. Sax is a freelance writer based in Chevy Chase, Md.