Nicotine Replacement Goes OTC In The USA

On April 18, SmithKline Beecham launched the first Food and Drug Administration-approved over-the-counter smoking-cessation product in the USA, in the form of its nicotine gum product Nicorette. Nicorette (nicotine polacrilex) is already marketed in more than 50 countries worldwide and is available without a prescription in 34 countries, including the UK.

In addition to this first nicotine gum approval, the FDA's Non-prescription Drugs Advisory Committee unanimously recommended on April 19 that both SB's Nicoderm and McNeil Consumer Products' Nicotrol transdermal nicotine patches should be switched from prescription-only to over-the-counter status, heralding a marketing battle in the smoking-cessation sector.

Both companies provided data from studies which satisfied the panel that OTC use was associated with acceptable quit rates, and that the products were safe for general sale. They also provided details of their marketing plans, aimed at deterring misuse of the products, eg making sure that users are aware that they should not smoke while using the patches.