Nicotine Nasal Spray an Alternative to the Nicotine Patch and Gum

TOBACCO August 1994

A Food and Drug Administration advisory panel warned that a nasal spray containing nicotine may be as addictive as cough mixtures containing codeine (an opiate) (John Schwartz, "Nasal Spray That Helps Smokers Quit Can Build New Addiction, FDA Panel Says," Washington Post, August 2, 1994, A3).

Because of the potential abuse of the spray due of its addictive nature, the FDA panel voted to categorize the spray as a schedule 5 controlled substance, subject to the same kinds of restrictions that apply to cough mixtures containing codeine. The FDA is not bound by the panel's recommendations, but often follows such recommendations.

Some FDA officials at the hearing expressed concern that some people will become addicted to the spray and abuse it. "We became seriously concerned" about long-term users, E. Douglas Kramer, a medical officer with the FDA's pilot drug evaluation staff, said. "I am worried that we have found a new dosage form for an old drug of abuse."

One panelist expressed amazement that the agency was worried about addiction. "If the goal of this was to get them to stop smoking, this seems to have been a great step in the right direction," Paul V. Luisada, director of the Northern Virginia Institute of Psychiatry, said.

John Grabowski of the Substance Abuse Research Center at the University of Texas Health Science Center testified before the committee and said that FDA officials were so worried about addiction that they had lost sight of the greater problem of tobacco-related illness. Addiction "seems to be a scientific problem, not a medical problem," he said.

The spray's maker, Swedish pharmaceutical company Pharmacia argues that classifying the drug with "dangerous drugs" like opiates is a mistake because it would make it difficult to acquire a safe source of nicotine while cigarettes, a more hazardous delivery system, would remain freely available.

If approved, the spray will join nicotine patches and gum as a treatment medication. Pharmacia reports that hard-core smokers are eight times more likely to quit smoking using the spray than using patches. The company also argues that it is highly unlikely that non-smokers will use the spray because of discomforts associated with its use.