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    • GSK receives USFDA...

    GSK receives USFDA panel backing for OTC nicotine oral spray for smoking de-addiction

    Farhat NasimWritten by Farhat Nasim Published On 2019-09-19T09:30:10+05:30  |  Updated On 17 Aug 2021 11:51 AM IST

    Johnson & Johnson (JnJ), GSK Plc's developmental partner, sell the over-the-counter nicotine oral spray in 45 countries, excluding the United States.


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


    The panel voted 9-6 in favour 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 use 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 a 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 a 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 a prescription.


    Johnson & Johnson (JnJ), GSK's developmental partner, sells the spray in 45 countries, excluding the United States.


    Also Read: GSK gets USFDA nod for Nucala, only biologic to treat eosinophilic asthma in age group 6-11 year

    GSKhabit forming drugJnJJohnsonlozengesNasal Spraynicotineoral speaypharmapharma companypharma newsprescription drugUSUSFDAUSFDA approved
    Source : Reuters

    Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd

    Farhat Nasim
    Farhat Nasim

      Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here

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