|Product type||Nicotine replacement therapy product|
|Owner||GlaxoSmithKline (US), Johnson & Johnson (outside the US)|
|Previous owners||AB Leo, Pharmacia, Pfizer|
Nicorette is the brand name of a number of products for nicotine replacement therapy (NRT) that contain nicotine. Developed in the late 1970s in Sweden by AB Leo in the form of a chewing gum, Nicorette was the first nicotine replacement product on the market.
The Nicorette product range encompasses chewing gum, lozenges, patches of two kinds (transparent and non-transparent), oral spray (Nicorette QuickMist), inhalator, sublingual tablets (Nicorette Microtab) and nasal spray.
Nicorette products are manufactured by McNeil Consumer Healthcare company, a subsidiary of Johnson & Johnson. GlaxoSmithKline is the licence holder of Nicorette gum in the United States while Johnson & Johnson markets Nicorette globally.
The brand name "Nicorette" comes from "nicotine" and Swedish: rette, "right way".
Nicorette products are indicated for the relief of withdrawal symptoms associated with nicotine withdrawal and to aid in smoking cessation. It is suggested that Nicorette products should be used in "conjunction with a behavioural support programme".
Prior to 2005 nicotine products in Britain were only licensed to "assist smokers who were making an immediate and complete quit attempt". Following advice from a working group set up by the Committee on Safety of Medicines (since 2005 the Commission on Human Medicines) the MHRA concluded that NRT products should be used also by those who are unable to stop abruptly.
Currently Nicorette products in the UK are indicated to:
- relieve craving (the urge to smoke),
- relieve withdrawal symptoms (irritability, impatience; difficulty in concentrating),
- improve the likelihood of a successful abrupt quit attempt,
- reduce the amount smoked in those not immediately motivated to quit.
The products are intended for adults and children over 12 years of age as well as pregnant and lactating women (it has been concluded that "the use of NRT in pregnancy does not give undue concern and any harm caused by nicotine replacement must be compared with that caused by continued smoking – which is extremely harmful to both the woman and her child".)
Nicorette products (like all other NRT products) are most beneficial for heavy smokers (more than 15 cigarettes per day). There are not enough studies to show that NRT helps those who smoke fewer than 10 cigarettes per day.
Up until recently cardiovascular disease was considered to be a contraindication to nicotine replacement therapy products. However, in 2003 the French Agency for the Safety of Health Products (AFSSAPS) removed all cardiovascular and cerebrovascular disease contraindications. In 2005 the UK Medicines and Healthcare Products Regulatory Agency followed suit. The rationale is that the benefit of nicotine replacement therapy outweighs the risks of nicotine medication, even in smokers with cardiovascular disease.
In 2013 the US FDA stated that the contraindication concerning usage of NRT products while smoking is no longer valid.
The FDA approved labeling for Nicorette products with a warning concerning pregnancy and breastfeeding: "This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known". The FDA suggests not using Nicorette products if the patient continues to smoke, or use chewing tobacco, snuff or other nicotine-containing products.
The FDA advises consulting a doctor before using the product if the patient previously had:
- heart disease, recent heart attack, or irregular heartbeat,
- high blood pressure,
- taken a prescription medicine for depression or asthma.
Specific contraindications listed by the FDA for various formats include sodium-restricted diet, stomach ulcer of diabetes (for gums and lozenges), or an allergy to adhesive tape or skin problems (for patches).
The FDA suggests stopping use of Nicorette products in cases of irregular heartbeat or palpitations, symptoms of nicotine overdose (nausea, vomiting, dizziness, weakness, and rapid heartbeat) or skin redness caused by the patch.
Mechanism of action, formats, dosages and administration
Nicorette chewing gum releases nicotine while chewing. Nicotine then is absorbed across the oral mucosa into the systemic circulation. Patients are advised to chew the gum slowly and intermittently to avoid the risk of releasing too much nicotine. It is also suggested not to eat or drink while chewing since foods and beverages can reduce nicotine absorption.
Nicorette chewing gum is available in two strengths: 2 mg/piece and 4 mg/piece. Dosing would depend on the degree of nicotine dependence: light smokers should use 2 mg gum, heavy smokers (more than 25 cigarettes a day) should use 4 mg gum. Patients should chew gum once they feel the craving. The average adult dosage is 9 to 12 pieces per day. FDA limits maximum daily amount of 2 mg gums to 24 pieces.
The patch supports smoking cessation within 12 week programme: 25 mg patch (25 mg nicotine over 16 hours) for eight weeks (Step 1), 15 mg patch for two weeks (Step 2), 10 mg patch for the last two weeks (Step 3). Light smokers (less than 10 cigarettes per day) were recommended to start at Step 2 (15 mg) for eight weeks and reduce the dose to 10 mg for the last four weeks.
Microtab supplies nicotine to the body orally. It is different from the chewing gum because instead of chewing the patient should allow the tablet to dissolve slowly under the tongue (the tablet dissolves in about 20-30 minutes). The action is similar to 2 mg nicotine gum.
Microtabs are used either for smoking cessation or smoking reduction. For smoking cessation the standard dose is one tablet (2 mg) per hour for patients who smoke less than 20 cigarettes per day. When the craving is strong two tablets can be taken instead of one. Most patients require between 8 and 24 tablets per day. British Medicines and Healthcare Products Regulatory Agency recommends not to exceed 40 tablets per day limit. Treatment should be stopped when daily consumption is around 1-2 tablets per day.
Nicorette QuickMist spray is a liquid solution spray in a polyethylene terephthalate (PET) bottle placed in a dispenser with a mechanical spray pump. One bottle contains 13.2 ml of solution (at least 150 sprays). The solution consists of 1 mg of nicotine, propylene glycol, anhydrous enthanol, trometamol, poloxamer 407, glycerol, sodium hydrogen carbonate, levomenthol, mint flavour, cooling flavour, sucralose, acesulfame potassium, hydrochloric acid and purified water.
Nicorette Quickmist is considered to be the most advanced format of nicotine replacement therapy due to the speed of action. As explained by Gay Sutherland, research Psychologist at the Tobacco Research Unit, Kings College "after taking a puff on a cigarette, smokers get nicotine hit to the brain within around 20 seconds. Most nicotine replacement therapies can take between 30 minutes and three hours to deliver their effect" while Nicorette Quickmist has a proven ability to deliver nicotine to the brain within 60 seconds. There is also clinical data proving that using Nicorette Quickmist double the chances of successfully quitting compared to willpower alone (a relatevie success rate of 2.48 compared to placebo regarding abstinence at 1 year).
The Nicorette brand started with a nicotine chewing gum developed in Helsingborg (Sweden) by the company Leo AB, later part of Pharmacia & Upjohn. It was the first product for nicotine replacement therapy and gained its inventor, Ove Fernö, titles like "the founding father of modern pharmacotherapy for smoking".
On December 12, 1967,:1216 Fernö, Vice President of Research and Development at AB Leo,:1215 received a mail from his friend Dr. Claes Lundgren at the Department of Aviation Medicine at the Physiological Institute of Lund University, suggesting he develop an orally consumed substitute for tobacco. He and his colleague Stefan Lichtneckert noted how submariners and aviation crews switched from cigarettes to chewing tobacco and snus when smoking was not possible. They also suggested the product name "Nicorette".:145
The first nicotine chewing gum was produced at AB Leo in 1971. The innovation was in the use of ion-exchange resin (polacrilex) in order to control the rate of release of nicotine during chewing. Fernö explained, "Putting nicotine into chewing gum is not an invention. Fixing the nicotine to an ion exchange resin and putting that in a chewing gum to enable the chewer to control the rate of release—that is an invention".:1220 The same year Håkan Westling, Professor of Clinical Physiology at Lund University, started the first clinical trials of the gum as an aid to smoking cessation at the university hospital. Westling's findings were presented at the Second World Conference on Smoking and Health in London:146 and were published in 1973 in the journal Psychopharmacologia together with an article by Fernö.
Nicotine chewing gum was presented at the Third World Conference on Smoking and Health in New York in 1975 by Fernö in partnership with the British researcher Michael Russell from the Institute of Psychiatry, who pioneered the measurement of blood nicotine levels. Russell and his colleagues at the Addiction Research Unit at the Institute of Psychiatry became involved in further research into nicotine gum through randomised controlled trials funded by the British Medical Research Council and the UK Department of Health and Social Security.:147
Nicorette was registered as a drug in Switzerland in 1978, in Canada in 1979, and in the UK in 1980.:147 It was registered in Sweden in 1981. Initially the Swedish Medical Products Agency declined to approve Nicorette as a medicine because it considered smoking not an addiction, but a lifestyle choice; and the Swedish National Board of Health and Welfare regarded orally consumed nicotine products not as medicine but as foodstuffs.
The Nicorette Patch was introduced to the market in 1991 and the nasal spray in 1994.
In 1996 the FDA approved the switch of Nicorette gum and the NicoDerm CQ transdermal nicotine patch to over-the-counter status in the US.
The Nicorette inhaler was launched in 1996 and Nicorette Microtab (sublingual tablets) in 1999.
In 2004 Nicorette launched Peppermint, the first coated nicotine gum. A shell coating containing a sugar substitute (xylitol) and flavouring masks the nicotine taste. In 2005 Nicorette introduced Fresh Mint chewing gum.
In December 2008 Nicorette introduced a new semi-transparent nicotine patch under the trade name "Invisipatch". As stated by the UK Medicines and Healthcare Products Regulatory Agency, in addition to this more discreet patch to encourage better customer compliance, new Nicorette transdermal patches have been developed to: reduce patch size; add a higher dosage strength of 25 mg of nicotine to the previously available 5, 10 and 15 mg; and increase the proportion of bioavailable nicotine).
In 2009 Nicorette introduced "Icy White" chewing gum with teeth whitening and Nicorette Mentolmint, a chewing gum with softer menthol taste.
At the end of November 2010 Nicorette introduced QuickMist 1 mg mouthspray, which provides more rapid absorption of nicotine than lozenges or gum.
Yacht race sponsorship
In 1995 the Nicorette team was banned from the Cape to Rio Race, sponsored by the tobacco company Rothmans. The captain of “Nicorette” protested against the decision, saying that “Rothmans is scared of the boat and the healthy lifestyle it seeks to promote”. A spokesperson for the organizing committee of the race later admitted that the yacht was barred because they considered the product to be in competition with the sponsor's product. In the same year the yacht won the Fastnet Race.
Second and third generations of “Nicorette” won the Sydney to Hobart Yacht Race in 2000 and 2004.
Car race sponsorship
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During the late 1960s and 70s he was responsible for the development of the first NR product – a chewing gum
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