The Nonprescription Drugs Advisory Committee (NDAC) of the Food and Drug Administration (FDA) has recommended the approval of the New Drug Application (NDA) from GlaxoSmithKline for an over-the-counter (OTC) nicotine mouth spray to aid in smoking cessation (9 to 6 vote).
The nicotine mouth spray (NMS) delivers 1mg nicotine per spray; each dispenser would deliver at least 140 sprays, with a maximum of 4 sprays per hour and 64 sprays per day. The device includes an actuator press fitted to the spray pump and a press-and-push locking mechanism designed to be child-resistant.
The recommendation was based on data from a clinical study program for NMS that included 2 pivotal efficacy phase 3 trials, 4 pharmacokinetic studies, 1 label comprehension study, and 1 human factors study. Data from the 2 multicenter, randomized, double-blind, placebo-controlled, phase 3 studies (Study A6431111 and Study CO-140121222102-SCCT) evaluated the efficacy of NMS vs placebo in smokers based on the continuous abstinence rate from Week 2 to 6 (primary end point) in a “typical” clinical setting and an “OTC setting,” respectively; abstinence was verified by an exhaled CO level of <10ppm.
Results from both studies demonstrated a statistically significant treatment difference from placebo for weeks 2 to 6. However, the treatment difference in the study that was planned to resemble OTC use was only 2%, with a corresponding number needed to treat of 40. “Based on these results, 40 smokers would need to be treated with NMS 1mg instead of placebo in the OTC setting in order to expect 1 additional person to be continuously abstinent for weeks 2 through 6,” the panel noted in meeting documents.
Regarding safety, the most common treatment-emergent adverse events in the phase 3 clinical trials included hiccups, headache, nausea, throat irritation, dyspepsia, and dizziness. One topic of concern was the potential for abuse, as the mouth spray provides a much faster absorption of nicotine than other approved nicotine replacement therapies. While some cases of recreational use leading to adverse events were described in the application, there were not many of them. “It is of interest that in Study 38, 79% of subjects in the active treatment group continued to use the product after the treatment period ended at Week 26, even though only 3.4% had quit smoking, suggesting dual use,” the committee stated.
Although not bound by the committees’ recommendations, the FDA does take them into consideration when making decisions on approval.
For more information visit fda.gov.