Nicotine Patch Gets Over-the-Counter OK
Pharmacia & Upjohn’s Nicotrol, a nicotine patch used to help smokers kick the habit, can now be sold without a prescription, the Food and Drug Administration said Wednesday.
The patch, marketed by Johnson & Johnson’s McNeil Consumer Products unit, is the first available over the counter.
“This is good news for millions of Americans who are serious about giving up smoking,” McNeil President Brian Perkins said.
The announcement came after the stock market closed. Shares in Kalamazoo, Mich.-based Pharmacia & Upjohn rose 12.5 cents to close at $44.25, and New Brunswick, N.J.-based Johnson & Johnson shares fell 37.5 cents to $49.38.
The patch, designed to be used daily for six weeks, provides a constant flow of nicotine into the blood supply, reducing a smoker’s nicotine cravings while he or she fights psychological addiction. Patients wear the Nicotrol patch on their upper torso for 16 hours a day.
Though Nicotrol is now the first nicotine patch available without a prescription, it is the second nicotine replacement therapy available over the counter.
The FDA recently approved SmithKline Beecham’s nicotine gum, called Nicorette, which hit store shelves in April. SmithKline is also seeking FDA approval for over-the-counter sales of its own nicotine patch, called Nicoderm and developed by Hoechst Marion Roussel and Alza Corp.
The companies expect that the additional availability of nicotine replacement therapies through nonprescription sales will expand the $250-million market.
Not everyone agrees, though. “It will be interesting to watch,” said Cowen & Co. analyst Ian Sanderson, who predicted that sales of nicotine replacement therapies won’t top $300 million a year.
“I’m not sure going OTC is going to make them take off,” Sanderson said. “Patients will go through the same cycle that they did when it was a prescription product.”
Executives of Fort Washington, Pa.-based McNeil said the product will be of great benefit to smokers who want to quit, because they can obtain it without going to a doctor. The patches, which will be available July 18, should sell for less than $30 for a one-week supply, the company said.
“That’s approximately equal to a pack and a half to two packs a day for someone smoking,” McNeil spokesman Ron Schmid said.
The patches also come with an audiotape and booklets containing advice on how to deal with the psychological addiction, McNeil said. In clinical studies, the company found that patients using the patches without the supervision of a doctor were just as successful as those under prescription treatment, said Barbara Korberly, McNeil’s director of medical new-product development.
Government figures show that most of the 46 million smokers in the U.S. say they want to quit.
