FDA Considers Nicotine Nasal Spray

The US Food and Drug Administration's Drug Abuse Advisory Committee has recommended that Pharmacia's nicotine nasal spray for smoking cessation requires distribution records to prevent abuse of the product. The committee also recommended that a limit should be imposed on the number of repeat prescriptions patients could obtain without reassessment by their physician.

The panel voted that the drug should be treated as a Schedule V drug, subject to the same kind of restrictions as apply to codeine-containing cough medicines. This is the least restrictive of the US Drug Enforcement Agency classifications, and in addition to distribution records and limited refills, requires a secure storage area for the drug, but the panel recommended against requiring secure storage or triplicate prescriptions.

Pharmacia's device contains one 100mg bottle of nicotine in water and each dose delivers about 1mg of nicotine, roughly a cigarettes's worth, within ten minutes. This is several times faster than either nicotine gum or nicotine patches, which the company also makes.