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GSK’s over-the-counter nicotine oral spray gets FDA panel backing

(Reuters) – An independent expert panel to the U.S. Food and Drug Administration on Wednesday recommended approval of GlaxoSmithKline Plc’s over-the-counter nicotine oral spray that aims to help smokers quit their addiction.

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

The panel voted 9-6 in favor of the therapy, saying its benefits as a smoking cessation aid outweighed risks. The FDA usually follows the recommendations of its experts, but is not mandated to do so.

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

The dose of nicotine is gradually reduced and then discontinued over a 12-week period, allowing the person to break out of the habit of smoking.

However, there is a possibility that patients could end up using the spray long after the recommended period and may even resort to using both cigarettes and the product, FDA staffers said in a review of the therapy on Monday.

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

Dr. Neil Farber of the University of California, San Diego, who voted against the product, said people may turn to using GSK’s oral therapy for “getting that immediate kick”, similar to what has happened with e-cigarettes.

E-cigarettes, which vaporize a nicotine-filled liquid, have been marketed as tools to help smokers quit and are available without prescription.

But their usage has been the subject of a crackdown in the United States amid its rising popularity among youth and reports of severe lung illnesses possibly linked to the products.

Although there has been a considerable decline in cigarette smoking among U.S. adults in the last 50 years, about 14% of all adults or 34 million people in 2017 were active smokers and smoking is estimated to cause more than 480,000 deaths per year, according to the Centers for Disease Control and Prevention.

Most types of nicotine replacement therapy have been approved for sale over the counter and are commonly available in the form of gum, lozenges and stick-on patches. Nasal sprays and oral inhalers are available in the United States, but only with prescription.

“It seems to me that there is sufficient safety data at least to show that it is not going to create a major concern,” said panel member Dorothy Hatsukami of the University of California, adding that the therapy is other countries without prescription.

Johnson & Johnson, GSK’s developmental partner, sells the spray in 45 countries, excluding the United States.

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

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