FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Advisory Committee Supports GSK’s OTC Nicotine Spray

Sept. 27, 2019
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An FDA advisory committee narrowly voted in favor of GSK’s over-the-counter novel Nicotine Mouth Spray as a nicotine replacement therapy.

The Nonprescription Drugs Advisory Committee voted 8-7 for the product’s efficacy, 9-6 for its safety, and 9-6 for its overall risk-benefit profile to reduce withdrawal symptoms associated with quitting smoking for consumers ages 18 years or older.

GSK presented the results of two multicenter, phase 3 clinical trials which demonstrated that the spray is effective at achieving statistically significant and clinically meaningful higher abstinence rates during smoking cessation treatment.

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