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GSK's over-the-counter nicotine oral spray wins US FDA panel backing

A U.S. Food and Drug Administration panel recommended the approval of GlaxoSmithKline PLC's over-the-counter nicotine oral spray as a smoking cessation aid, Reuters reported.

The FDA's Nonprescription Drugs Advisory Committee in a Sept. 18 meeting voted 9-6 in favor of the therapy, noting the oral spray's benefits outweigh its risks.

U.K.-based GlaxoSmithKline developed the nicotine oral spray to help reduce withdrawal symptoms, including nicotine craving, in adults aged 18 years and above trying to quit smoking. The product has a recommended limit of four sprays per hour, with a maximum of 64 sprays a day.

After 10 to 12 weeks, the patient is advised to reduce the daily number of sprays.

However, the panel raised the possibility of patients continuing to use the spray even after the recommended 12-week period or the use of both cigarettes and oral spray. The committee also noted the potential for abuse and misuse of the product by non-smokers and teenagers.

The committee makes recommendations to the FDA, but its recommendations are not binding and the regulator may still decide against approving the spray.

GlaxoSmithKline's developmental partner Johnson & Johnson is currently marketing the spray in 45 countries, excluding the U.S.