Kenvue publishes clinical evidence showing nicotine mouth spray is effective for relief of vaping cravings

Helsingborg, Sweden – September 25, 2024 – Kenvue Inc. (the Company or Kenvue), the world’s largest pure-play consumer health company by revenue, and maker of Nicorette^®*, leading Nicotine Replacement Therapy (NRT), today announced the publication of clinical trial results** demonstrating that nicotine mouth spray can be a promising strategy for vaping cessation. The findings were published in the Addiction Journal on September 24. This is the first clinically proven NRT to be used for vaping cravings and Nicorette^® QuickMist has been licensed by the MHRA as a nicotine vaping cessation product in the UK since 2022.

The study found that Nicorette^® QuickMist mouth spray delivering a two-milligram dose of nicotine, within the first hour after administration, was significantly more effective than placebo in providing fast relief of urges to use E-cigarettes, also known as vaporizers or vapes. This was observed in regular and exclusive vapers who had abstained for 12 hours.

The study, titled “Effect of Nicotine Mouth Spray on Urges to Vape: A Randomized, Placebo-Controlled, Pharmacodynamic Clinical Trial in Exclusive E-Cigarette Users,” was conducted at Hammersmith Medicines Research Ltd (HMR), London, UK by Tobias Danielsson, BSc, Hedvig Bennet, PhD, Bryan McColgan, MD, Jianfeng Wang, PhD, and other clinical research experts at Kenvue in Helsingborg, Sweden.

“There are health-related and financial costs associated with vaping, and while studies suggest that most of the world’s 82 million¹ E-cigarette users want to quit², that can be challenging without a reliable therapeutic aid,” said Rajesh Mishra MD, PhD, Chief Medical Officer at Kenvue***. “Faster acting than other replacement therapies³, nicotine mouth spray has been shown to have a good safety profile and effectively help people stop smoking tobacco cigarettes, but ours was the first well-controlled trial to explore the strategy in vaping. Kenvue is thrilled to have identified a therapy for the relief the vaping cravings that are known to drive addiction, with the potential to help millions in tackling their reliance on E-cigarettes.”

Kenvue research shows that nearly seven in 10 vapers wish to quit or reduce.⁴

Study Design

The randomized, double-blinded, placebo-controlled study enrolled 216 healthy volunteers ages 18 to 65 who had a history of smoking E-cigarettes at least 10 times a day, starting within 30 minutes of waking up.

After abstaining from vaping overnight, the participants received two administrations of either one milligram nicotine mouth spray or placebo. They rated their urge to vape just before treatment and then afterwards at various time points over two hours.

They were then given mouth spray to use, in line with product instructions, over an 11-hour period.

Study results

In the hour after the first dose, nicotine mouth spray was associated with significantly greater reductions in the urge to vape compared with placebo. Based on a visual analogue scale ranging from 0 mm to 100 mm, the estimated average reduction in the mean urge to vape was 18.9 mm in the placebo group versus 30.8 mm in the mouth spray group, for a statistically significant difference of 11.9 mm between the two cohorts (95% CI [6.86, 16.95]; p < .001).

Notably, at just 30 seconds after the first dose, there was already a statistically significant mean treatment difference of 9.6 mm favoring the study treatment (95% CI [4.96, 14.27]; p < .001).

Over 11 hours, 21 (19.6%) participants in the placebo group versus 37 (33.9%) in the nicotine mouth spray group achieved complete control of their urges to vape. Overall, about 80% of participants receiving study drug achieved at least a 50% reduction in their urge to vape at some point during treatment.

The research team noted the clinical significance of these findings, given that relief of cravings is a critical part of managing and overcoming addiction. Kenvue researchers continue to build on these findings and are currently conducting a vaping cessation Phase III clinical trial.

Safety Findings

Treatment-related adverse events were mild or moderate, affecting 78 participants (17 of 107 in the placebo group and 61 of 109 in the nicotine group). Similar to results from previous studies in smokers of tobacco cigarettes, nicotine mouth spray was most commonly associated with throat irritation (22.9% of participants), hiccups (18.3%), headache (11 %), nausea (8.3%) and dyspepsia and oral discomfort (5% each).

To learn more about this study or to schedule interviews with its authors, please contact Kenvue media relations.

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About Kenvue

Globally, Kenvue is the world’s largest pure-play consumer health company by revenue. Built on more than a century of heritage, our iconic brands including Nicorette®††, Aveeno®, Johnson’s® Baby, Listerine®, Neutrogena®, Calpol®, OGX® and Imodium®, are science-backed. At Kenvue, we believe in the extraordinary power of everyday care and our teams work every day to put that power in consumers’ hands and earn a place in their hearts and homes. Learn more at www.kenvue.com/uk.

††Nicorette® is not sold or marketed by Kenvue in the U.S

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding Nicorette^® as a strategy for vaping cessation. Forward-looking statements may be identified by the use of words such as “plans,” “expects,” “will,” “anticipates,” “estimates” and other words of similar meaning. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Kenvue Inc. (“Kenvue”) and its affiliates.

A list and descriptions of risks, uncertainties and other factors can be found in Kenvue’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2023 and subsequent Quarterly Reports on Form 10-Q and other filings, available at www.kenvue.com or on request from Kenvue. Kenvue and its affiliates undertake no obligation to update any forward-looking statements, whether as a result of new information, future events or developments or otherwise.