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For Women Only
Oxytrol for Women (oxybutyn transdermal system, 3.9 milligrams per day), for the treatment of overactive bladder, created a new OTC segment when it made the switch from prescription to over the counter (OTC) last year.
"In less than a year on the market in OTC form, Oxytrol has become an $18 million product," notes Lisa Buono, a health care expert at Chicago-based market research firm Information Resources Inc. (IRI). "It's created a new category and is slowly building, but the need base is small."
A question still facing retailers, however, is whether to merchandise the product in the feminine hygiene or the incontinence section.
More to Digest
The digestive health category is a crowded playing field, including products to treat GERD, a chronic disorder characterized by heartburn and acid reflux. GERD affects 10 percent to 20 percent of U.S. adults.
Over the past few years, high-profile proton-pump inhibitor (PPI) switches from prescription to OTC have become a significant segment of the category, since they actually inhibit the production of acid rather than just treat reflux symptoms.
Nexium, which had prescription sales of $3.9 billion in 2013, "should get an initial bump from prescription customers who can now purchase the product over the counter," says Kyle Lentz, an analyst at Waukesha, Wis.-based Hamacher Resource Group.
According to Stacie Maass, SVP, pharmacy practice and government affairs at the Washington, D.C.-based American Pharmacists Association (APhA), approval of an OTC statin would be a big step for the retail channel. Statins are currently prescribed for atherosclerosis, which can lead to such health conditions as chest pain, heart attacks and strokes.
"These drugs are used to treat progression of disease, not merely symptoms," observes Maass. "APhA has been a proponent of an intermediate category [of drugs not requiring a prescription but available only after consultation with a pharmacist] that would be monitored post-market as well. That third class could be a stepping stone to OTC status."