US FDA Approves McNeil's Nicotrol NS

The US Food and Drug Administration has approved a nicotine nasal spray, developed by Pharmacia & Upjohn but licensed to McNeil Consumer Products, which will be marketed as Nicotrol NS. The product will be available on prescription to help adult smokers give up the habit. Each pump bottle contains 100mg nicotine.

The agency warned that smokers could become dependent on the nicotine in the nasal spray, so they should try the spray for about three months, and never longer than six months. The FDA also expressed concerns that inappropriate use of the spray could lead to an overdose. It is more powerful than gum or patches since it hits the bloodstream faster. A 40mg dose of nicotine taken at one go can be fatal, so smokers are warned not to inhale the product more than five times a day. McNeil said it would begin selling the product later this year, but did not disclose a launch date or price.

Tracking System While the likelihood of addiction is small, P&U must track usage of Nicotrol NS to show the FDA that smokers are not abusing it and that the spray is not being used by adolescents. The company must also investigate the best way for smokers to wean themselves off the spray with the least chance of resuming cigarette use.