Food & Drug Administration advisory committees have recommended the prescription drug Nicorette gum become the first over-the-counter nicotine replacement therapy approved by the FDA; currently, available nicotine replacement therapies are only available by prescription. Final approval should come shortly for the product that will be marketed to consumers in a joint venture by SmithKline Beecham, Philadelphia, and Hoechst Marion Roussel, Kansas City, Mo.
"We think the timing is ideal, with attention to smoking policies at work and legislation in recent years," said Brad Burdick, senior brand manager at SKB. "We see this as a solution to the public health problem."
Nicorette-the only nicotine replacement therapy available from 1984 until 1992, when nicotine patches were approved-had a 24% share of the $263 million smoking deterrent market for the 52 weeks ended July 1, according to Scott-Levin Associates, Newtown, Pa.
The rest of the business is made up of patches, led by HMR's Nicoderm with a 39% share, followed by Ciba Geigy Corp.'s Habitrol with a 24%, Parke-Davis' Nicotrol's 6.7% and Wyeth-Ayerst-Lederle Labs' ProStep with a 3.4%.
With FDA approval, Nicorette will beat a number of the patches to OTC status.
The quitter's market, down 33% from $392 million in July '93, could use some fire.
SKB believes going OTC will ignite static sales of Nicorette. "One of the main issues we see is access," said Mr. Burdick. "Seven out of 10 smokers want to quit, but two-thirds of those won't see a doctor. Typically there is a doubling of sales for products that switch from [prescription]-we're hoping to keep the trend."
NCI Advertising, New York, handled trade and direct to consumer advertising; Jordan, McGrath, Case & Taylor, New York, will handle the consumer OTC account. Marketing support is likely to be in excess of $15 million. According to Competitive Media, SKB spent only $330,000 in 1994 supporting the brand, but for 1995 through September, support has totaled $1.1 million.
Nicorette, which lost patent protection in early 1994, has had no competition because the FDA didn't approve a generic nicotine gum. SKB said that it will get renewed patent protection for three years once approved for OTC.
Because so much of a quitter's success depends on psychology, SKB and HMR are investing in several supplemental aids as part of the drug purchase. As with the prescription version of the drug, a card for counseling from Committed Quitters, a self-help group created by HMR for Nicoderm, will be included in the starter package as well as an audio tape and a self-help booklet with a 10-day supply of gum for about $40.
Industry observers think the product will do acceptably OTC but are not expecting a sales turnaround for the category.
"The first smoke cessation company reaching OTC will see a spike in sales but that may be short-lived," said Michael Perlmutter, senior consultant-pharmaceutical group with Kline & Co., Fairfield, N.J.