Aradigm finds pure nicotine effective in smoking cessation therapy

Aradigm’s randomized, open-label, single-site Phase I trial evaluated arterial plasma pharmacokinetics and subjective acute cigarette craving when one of three nicotine doses (0.2mg, 0.4mg and 0.7mg) was administered to 18 adult male smokers. Nearly all subjects reported an acute reduction in craving or an absence of craving immediately following dosing.

Neal Benowitz, professor of medicine at Psychiatry and Biopharmaceutical Sciences and chief of clinical pharmacology at the University of California, San Francisco, said: “Smoking researchers have believed for some time that a ‘pure nicotine’ pulmonary inhaler that would produce rapid absorption of nicotine into the blood stream, similar to that obtained from tobacco cigarette smoking, could be an important tool in the effort to reduce tobacco-induced disease.

“Such an inhaler used instead of a cigarette would eliminate exposure to the combustion products that are primarily responsible for disease, and might be an effective smoking cessation treatment. Aradigm’s inhaler in this trial appears to yield the desired nicotine pharmacokinetic profile; and the impact on the acute craving for cigarettes is also encouraging.”