FDA Panel Recommends Approval for OTC Nicotine Mouth Spray

The FDA’s Nonprescription Drugs Advisory Committee last month narrowly voted in favor of approval of GlaxoSmithKline’s OTC nicotine mouth spray to aid smoking cessation in people aged 18 years and older. Although the FDA is not obligated to follow the committee’s recommendations, the agency usually does so. The spray is currently marketed in 45 countries.

Each spray delivers 1 mg of nicotine. Users would take up to four sprays per hour and a maximum of 64 sprays per day when they get the urge to smoke.

The committee’s recommendation was based on the results of eight clinical trials, including two multicenter phase 3 studies. The studies compared smoking abstinence in participants who used the spray with those who received a placebo and showed a statistically significant treatment difference between the two groups from week 2 to week 6. The results were not particularly strong (the number needed to treat was 40, meaning 40 smokers would need to be treated with 1 mg of the spray instead of placebo for one more smoker in the treatment group compared with the placebo group to refrain from smoking during those weeks). At the end of 26 weeks, only 3.4% of patients in the treatment group had quit smoking, but 79% kept using the product, suggesting participants continued to use cigarettes along with the spray. ■