Nicotine Mouth Spray Is Preferred Replacement Therapy For Smoking Cessation

Main Category: Smoking / Quit Smoking
Also Included In: Respiratory / Asthma;  Clinical Trials / Drug Trials
Article Date: 18 Feb 2007 - 0:00 PDT

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This pilot study recently published in the journal "Respiration" shows that nicotine mouth spray is a preferred replacement therapy despite a higher rate of local adverse effects compared to oral inhalers and gum.

Various formulations of nicotine replacement therapy are commercially available. It was the aim of this study to test preference, safety and efficacy of a new nicotine mouth spray (1 mg/actuation; NicoNovum). To this effect, 100 healthy smokers wanting to quit (mean age 43.1 ± 11.2 years) were included. They were given the mouth spray, as well as 2-mg nicotine gums and nicotine oral inhalers to try out for 1 week. Subsequently, all participants were randomized into 3 groups mouth spray (n = 50), gum (n = 25) and inhaler (n = 25) �" and treated for 3 months.

Fifty-four of the 100 smokers preferred the spray, compared with 28 and 18 who preferred the gum and inhaler, respectively (p < 0.01 for spray vs. both the gum and inhaler). At 6 months, the sustained abstinence rates were 8 (16%), 5 (20%) and 2 (8%) for the mouth spray, gum and inhaler, respectively (p values = n.s.). Adverse effects were mostly drug-related local symptoms, most frequently reported at the end of the tryout period: out of 106 drug-related adverse effects, 90 were due to the spray, 11 and 5 to the inhaler and gum, respectively. The three most frequent adverse effects were almost exclusively caused by the spray: burning of the tongue/throat reported by 35, nausea by 18, and hiccup by 16 participants.

Despite a higher rate of local adverse effects, participants preferred the mouth spray over the gum and inhaler. The efficacy of the mouth spray seemed comparable with the one obtained by the gum and inhaler. Further studies are therefore necessary to show whether a reduction in the dose per actuation to about 0.5 mg would result in less side effects, which in turn might yield higher long-term drug compliance and possibly higher success rates than the ones achieved with other forms of nicotine replacement therapy.

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