McNeil's Nicotrol is first nicotine patch switched by FDA; will be in stores by July 18.

NICOTROL NICOTINE PATCH WILL BE ON SHELVES BY JULY 18, following July 3 approval from FDA for OTC marketing, McNeil Consumer announced. The transdermal patch will be available in a 15 mg strength to be used daily for six weeks. Nicotrol was unanimously recommended as safe and effective for over-the-counter use as a smoking cessation aid by FDA's Nonprescription Drugs Advisory Committee and members of the Drug Abuse Advisory Committee on April 19 ("The Tan Sheet" April 22, p. 1).

Suggested retail pricing for the Nicotrol kits has not yet been determined, according to McNeil. However, the company says it is aiming to price the OTC nicotine patch therapy so that it will cost smokers "under $30" a week for the six-week program. Starter kits will include "behavior change" materials such as booklets, an audiotape and a toll-free "help-line" number.

Prescription Nicotrol has been on the market since 1992, but under a different dosing regimen. Instead of the "simplified" six-week course of 15 mg therapy selected for the OTC product, the Rx version consists of "tapered" therapy from 15 mg to 5 mg over a six-week period.

McNeil will be first to market with its nicotine patch, but others are likely to follow quickly. SmithKline Beecham's Nicoderm patch also was unanimously recommended for OTC approval at the April advisory committee meeting and has a safety and efficacy profile extremely close to Nicotrol's. Although slightly different from the Rx version, the proposed dosing for OTC Nicoderm will remain an incrementally decreasing schedule.

Ciba Self-Medication's Habitrol patch was not reviewed at the meeting, but the company is understood to have submitted an NDA supplement in support of OTC marketing of the patch ("The Tan Sheet" April 22, p. 4).

Publicity materials regarding Nicotrol's approval stress that "some people, including pregnant and nursing women [and] individuals with heart disease, high blood pressure or a recent heart attack should check with their doctors" before using the patch and that additional cautions will be included in the OTC labeling. A July 3 FDA "Talk Paper" adds that people "who take certain prescription medications for depression or asthma should speak with their doctors before using the Nicotrol patch." Side effects "are usually mild," McNeil noted, "with the most common being skin rash where the patch is applied."

The pending launch of Nicoderm will bring a second Rx-to-OTC switch smoking cessation product to the OTC market. SmithKline Beecham's Nicorette nicotine replacement chewing gum has been on store shelves since April ("The Tan Sheet" April 22, pp. 5-6). Available in a 108-count starter kit with supplementary materials, Nicorette 2 mg and 4 mg retails between $45 and $55.

McNeil's Nicotrol NS nicotine replacement therapy nasal spray was approved by FDA for prescription use in March and, like the patch, is scheduled to launch in July ("The Tan Sheet" April 1, p. 15). Given the current favorable climate for smoking cessation aids, the nasal spray seems a likely candidate for a future Rx-to-OTC switch application.