Kenvue has published clinical evidence demonstrating that nicotine oral spray effectively alleviates e-cigarette addiction

Helsingborg, Sweden – September 25, 2024 – Kenvue, Inc. (the Company), the world's largest single-business consumer health company by revenue, and creator of the Nicorette®* brand (a leading nicotine replacement therapy (NRT)), today announced the release of clinical trial results demonstrating that nicotine oral spray holds promise as an effective method for smoking cessation. The findings were published in the journal Addiction on September 24. This marks the first clinically validated NRT proven to curb e-cigarette device addiction. Since 2022, Nicorette® QuickMist oral spray has been licensed by the MHRA in the UK as a product to curb nicotine addiction.

The study found that Nicorette® QuickMist delivers a 2mg dose of nicotine within one hour of administration, significantly outperforming a placebo in rapidly reducing the urge to vape. This effect was observed in both regular e-cigarette users and exclusive e-cigarette users 12 hours after quitting.

The study, titled "Effect of Nicotine Oral Spray on the Urge to Vape: A Randomized, Placebo-Controlled Pharmacodynamic Clinical Trial in E-Cigarette-Only Users," was conducted at Hammersmith Medicines Research Ltd. in London, UK, by Tobias Danielsson, BSc; Hedvig Bennet, PhD; Bryan McColgan, MD; Jianfeng Wang, PhD; and other clinical research specialists from Kenvue in Helsingborg, Sweden.

Rajesh Mishra, Chief Medical Officer and MD, PhD at Kenvue***, stated: " "There are significant health and economic costs associated with e-cigarette use. Research indicates that among the 82 million e-cigarette users globally, the majority wish to quit. However, without reliable therapeutic support, this remains a highly challenging endeavor. Compared to other alternative therapies, nicotine oral spray delivers faster effects and demonstrates favorable safety profiles, effectively aiding individuals in tobacco cessation. Our study is the first well-controlled trial exploring e-cigarette cessation methods. Kenvue is pleased to have identified a therapy that alleviates the craving for e-cigarettes—a craving that can easily develop into addiction—which has the potential to help millions overcome their dependence on e-cigarettes."

Kenvue research indicates that approximately 7 out of 10 e-cigarette users wish to quit or reduce their use.

Study Design

This randomized, double-blind, placebo-controlled study enrolled 216 healthy volunteers aged 18 to 65 with a history of e-cigarette use, who smoked at least 10 puffs daily starting within 30 minutes of waking.

After abstaining from vaping overnight, participants received one of two treatments: 1 mg nicotine oral spray or placebo. Before and after treatment, they rated their urge to vape at various time points over a two-hour period.

The oral spray was then administered according to product instructions during an 11-hour cycle.

Study Results

One hour after the first dose, the nicotine oral spray demonstrated a significantly greater reduction in e-cigarette cravings compared to the placebo. On a 0- to 100-millimeter visual analog scale, the placebo group's average urge to vape decreased by 18.9 millimeters, while the spray group's decreased by 30.8 millimeters. A statistically significant difference of 11.9 millimeters (95% CI [6.86, 16.95] ; p < .001).

Notably, the mean treatment difference was already statistically significant at 30 seconds post-first dose, showing a treatment difference of 9.6 mm (95% CI [4.96, 14.27]; p < 0.001).

Within 11 hours, 21 participants (19.6%) in the placebo group and 37 participants (33.9%) in the nicotine oral spray group achieved complete control over the urge to use e-cigarettes. Overall, approximately 80% of participants receiving the study medication.