GSK oral nicotine spray gets FDA panel support


(Reuters) – An independent expert panel for the Food and Drug Administration on Wednesday recommended the approval of GlaxoSmithKline Plc's nicotine spray mouth which aims to help smokers resign their addiction.

PHOTO FILE: The GlaxoSmithKline (GSK) logo is on top of GSK Asia House in Singapore, March 21, 2018. Picture taken 21 March, 2018. REUTERS / Loriene Perera

The panel 9-6 voted in favor of the therapy, saying that the benefits it had as a help to quit smoking were greater than the risks. The FDA usually follows the recommendations of its experts, but is not directed to do so.

Each spray delivers one milligram of nicotine and is intended to be used within the recommended limits of 4 sprays per hour and a maximum of 64 spray per day when the person is asked to smoke.

The dose of nicotine is gradually reduced and eliminated over a 12-week period, allowing the person to quit smoking.

However, there is the possibility that patients could use the spray long after the recommended period and could even use cigarettes and the product, FDA staff said in a review of the therapy on Monday.

Panel members also raised concerns about the potential for misuse and misuse of the product by non-smokers and teenagers.

Dr. Neil Farber from the University of California, San Diego, who voted against the product, could get people to use GSK's oral therapy to “get the kick immediately” so, like what happened with e-cigarettes.

E-cigarettes, which make up liquid liquid nucleus, are marketed as tools to help smokers quit and are available without prescription.

But their use is subject to crackdown in the US among its popularity among young people and reports of major lung illnesses that may be linked to the products.

While cigarette consumption among adults in the United States has declined significantly over the last 50 years, approximately 14% of adults or 34 million people in 2017 were active smokers and tobacco smokers are estimated to have more than 480,000 smokers. per annum, according to Centers for Disease Control and Prevention.

Most nicotine replacement therapies were approved for sale over the counter and are usually available in the form of gum, lozenges and patches affixed. Nose sprays and oral inhalers are available in the United States, with only prescriptions.

“It seems to me that there is at least a lot of safety data to show that there will not be a big concern,” said Dorothy Hatsukami, a member of the panel at the University of California, adding that therapy is not other countries.

Johnson & Johnson, GSK's development partner, sells the spray in 45 countries, rather than the United States.

Reporting by Saumya Sibi Joseph and Manas Mishra in Bengaluru; Edited by Shounak Dasgupta and Arun Koyyur

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