Nicorette

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Nicorette
Product type Nicotine replacement therapy product
Owner GlaxoSmithKline (US), Johnson & Johnson (outside the US)
Country Sweden
Introduced 1978
Markets Worldwide
Previous owners AB Leo, Pharmacia, Pfizer
Website www.nicorette.com

Nicorette is the brand name of a number of products for nicotine replacement therapy (NRT) that contain nicotine. Developed in late 70s in Sweden by AB Leo in the form of a chewing gum Nicorette was the first nicotine replacement product on the market.[1]

Nicorette product range consists of chewing gum,[2][3][4][5] lozenges,[3][4] patches[5] of two kinds (transparent and non-transparent),[3] oral spray (Nicorette QuickMist),[6][7] inhalator,[3][5] sublingual tablets (Nicorette Microtab)[3] and nasal spray.[3][8]

Nicorette products are manufactured by McNeil Consumer Healthcare company, a subsidiary of Johnson & Johnson.[5] GlaxoSmithKline is the licence holder of Nicorette Gum in the United States while Johnson & Johnson markets Nicorette globally.[9]

NRT products including gum and transdermal patch are on the WHO Model List of Essential Medicines.[10]

Brand name "Nicorette" comes from "nicotine" and Swedish: rette, "right way".[11]

History[edit]

Nicotine gum development[edit]

Nicorette brand started from a nicotine chewing gum developed in Helsingborg (Sweden) by Leo AB company (later – part of Pharmacia & Upjohn). It was the first product for nicotine replacement therapy [1] and gained its inventor Ove Fernö titles like “the founding father of modern pharmacotherapy for smoking”.[12]

1967 – On December 12, 1967[13][14]:1216 Ove Fernö, Vice President of Research and Development at AB Leo[14]:1215 received a mail from his friend Dr. Claes Lundgren at the Department of Aviation Medicine at the Physiological Institute of Lund University, suggesting to 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 a product name “Nicorette” (from “nicotine” and Swedish: rette, “right way”).[11]:145

1969 - Ove Fernö began experimenting with the chewing gum and quitted smoking himself after one year of using chewing gum.[14]:1218

1971 – First nicotine chewing gum produced at AB Leo. The innovation was in the use of ion-exchange resin (polacrilex) in the gum, in order to control the rate of release of nicotine during chewing. As explained by the inventor himself, “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”.[14]:1220 Same year Håkan Westling, Professor of Clinical Physiology at Lund University, started first clinical trials at the University Hospital in Lund. Results of his findings were presented at the Second World Conference on Smoking and Health in London.[11]:146

1973 – Westling’s findings published at “Psychopharmacologia” journal along with the article of Ove Fernö.[15][16]

1975 – Nicotine chewing gum presented at the Third World Conference on Smoking and Health in New York where Ove Fernö partnered 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 of nicotine gum through randomized controlled trials funded by the British Medical Research Council and the UK Department of Health and Social Security.[11]:147

1978 – Nicorette registered as a drug in Switzerland.[11]:147

1979 – Nicorette registered as a drug in Canada.[11]:147

1980 – Nicorette registered as a drug in the UK. [11]:147

1981 – Nicorette registered in Sweden. Initially the Swedish Medical Products Agency did not approve Nicorette as a medicine because at that time smoking was considered not an addiction, but a lifestyle choice. Also Swedish National Board of Health and Welfare regarded orally consumed nicotine products not as medicine but as foodstuffs.[17]

1984 – On January 13, 1984 Nicorette chewing gum was approved by the US Food and Drug Administration after a 34-month review. It was brought to the US market by Marion Merrell Dow under the license from AB Leo.[18]

Further product development[edit]

Nicorette Nasal spray
Nicorette inhalator

1991 - Nicorette Patch introduced to the market.[19]

1994 - Nasal spray developed.[20]

1996 – FDA approved the switch of Nicorette gum and NicoDerm CQ transdermal nicotine patch to over-the-counter status.[21]

1996 - Nicorette inhaler launched.[20]

1999 - Nicorette Microtab ("sublingual tablets) launched.[22]

2002 – FDA changed the status of Commit lozenges to the OTC status.[21]

2004 – Nicorette launched Peppermint, the first coated gum.[20] Candy-like shell coating enhanced with a sugar substitute (xylitol) and flavoring allowed to prolong release of flavor and sweeter from chewing gum.[23] This allowed to develop sweater and better tasting nicotine gums with nice tasting fruity and mint tastes that overpower rather unpleasant taste of nicotine.[24]

2005 – Nicorette introduced Fresh Mint chewing gum.[25]

2008 - In December 2008 Nicorette introduced new semi-transparent nicotine patch under the trade name "Invisipatch".[26]

As stated by Medicines and Healthcare Products Regulatory Agency new patches have been developed from previously available Nicorette Transdermal Patches to:

  • reduce the area size of the patch,
  • add higher strength of 25 mg nicotine (previous dosage strengths - 5, 10 and 15 mg),
  • improve nicotine utilization (increased proportion of bioavailable nicotine),
  • introduce a translucent backing layer for a more discreet patch and better consumer compliance.[26]

2009 - Nicorette introduced "Icy White" chewing gum with the teeth whitening effect[27] and Nicorette Mentolmint, a chewing gum with softer menthol taste.[20]

2010 - In the end of November 2010 Nicorette introduced QuickMist 1 mg mouthspray.[28] This new format of nicotine replacement therapy provided more rapid absorption of nicotine compared with lozenge or gum.[29]

2011 - In January 2011 Nicorette UK launched ActiveStop mobile app for iOS that featured target setting, a wish list, distractions, achievement sharing, information and games.[30][31]

Mechanism of action[edit]

The nicotine from Nicorette replaces some of the nicotine the smoker previously got from tobacco smoke; this relieves some of the craving and withdrawal symptoms, and allows the ex-smoker to concentrate on overcoming the habitual action of smoking. Nicotine is the addictive component in cigarette smoke and the reason for smoking, but the harm caused by smoking is mostly due to other components in the smoke such as tar, carbon monoxide and other gases.

The full dose of Nicorette should be used for about eight weeks, and then the dose can gradually be reduced before treatment stops. Nicorette Gum is available in two strengths, either nicotine 2 mg or 4 mg. The nicotine is bound to an ion-exchange resin (polacrilex) in the gum, in order to control the rate of release of nicotine during chewing.

Therapeutic indications[edit]

Nicorette products are indicated for the relief of withdrawal symptoms associated with Nicotine withdrawal and to aid in smoking cessation.[32] It is suggested that Nicorette products should be used in "conjunction with a behavioural support programme".[32]

Prior to 2005 nicotine products in Britain were only licensed to "assist smokers who were making an immediate and complete quit attempt"[33] Following advice from a working group set up by the Committee on Safety of Medicines (currently Commission on Human Medicines) MHRA concluded that NRT products should be used also by those why are unable to stop abruptly.[33]

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.[33]

The products are intended for adults and children over 12 years of age as well as pregnant and lactating women[34] (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"[35]).

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.[36]

Contraindications[edit]

Typical contraindication for Nicorette products is hypersensitivity to nicotine.[32][34]

Up until recently cardiovascular disease was considered to be contraindication to nicotine replacement therapy products. However, in 2003 French French Agency for the Safety of Health Products (AFSSAPS) removed all cardiovascular and cerebrovascular disease contraindications. In 2005 similar action has been taken by the UK’s Medicines and Healthcare Products Regulatory Agency. The rationale behind it is that the benefit of nicotine replacement therapy outweighs the risks of nicotine medication, even in smokers with cardiovascular disease.[37]

In 2013 FDA stated that the contraindication concerning joined usage of NRT products while smoking is no longer valid.[38]

FDA approved labeling for Nicorette products contain warning concerning pregnancy and breastfeeding, stating, "This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known".[39]

FDA suggests not to use Nicorette products if the patient continues to smoke, chew tobacco, snuff or other nicotine containing products.[39]

Consulting a doctor is advised by FDA 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 from FDA for various formats include sodium-restricted diet, stomach ulcer of diabetes (for gums[39] and lozenges), an allergy to adhesive tape of skin problems (for patch).[40]

It is suggested to stop using Nicorette products in cases of irregular heartbeat or palpitations, symptoms of nicotine overdose (nausea, vomiting, dizziness, weakness, and rapid heartbeat)[39] or skin redness caused by the patch.[40]

Mechanism of action, formats, dosages and administration[edit]

Chewing gum[edit]

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.[41]

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.[41] Patients should chew gum once they feel the craving. The average adult dosage is 9 to 12 pieces per day.[41] FDA limits maximum daily amount of 2 mg gums to 24 pieces.[39]

It is suggested to use gum following a 12 week schedule, reducing the amount of gums consumed by the end of the therapy.[39]

Invisi Patch[edit]

The patches provide slow absorption of nicotine into blood within the day and work for 16 hours.[42] They are usually applied in the morning and removed at bedtime.

The patch supports smoking cessation within 12 week programme: 25mg patch (25mg nicotine over 16 hours) for eight weeks (Step 1), 15mg patch for two weeks (Step 2), 10mg patch for the last two weeks (Step 3). Light smokers (less than 10 cigarettes per day) were recommended to start at Step 2 (15mg) for eight weeks and reduce the dose to 10mg for the last four weeks.[43]

Microtab[edit]

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).[44] The action is similar to 2 mg nicotine gum.[44]

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 to 24 tablets per day.[42] British Medicines and Healthcare Products Regulatory Agency recommends not to exceed 40 tablets per day limit.[45] Treatment should be stopped when daily consumption is around 1-2 tablets per day.[42]

Brand communication[edit]

Yacht race sponsorship[edit]

Nicorette is sponsoring yacht racing since 1993[46] when it partnered with Ludde Ingvall, Finnish-born Swede, who started a non-smoking team in 1991.[46]

In 1995 Nicorette team was banned from Cape to Rio Race, sponsored by the tobacco company Rothmans. The captain of “Nicorette” protested against the decision by saying that “Rothmans is scared of the boat and the healthy lifestyle it seeks to promote”.[47] Later a spokesperson for the organizing committee of the race admitted that the yacht was barred because they considered the product to be in competition with the sponsor's product.[48] In the same year the yacht won Fastnet Race.

In 1997 the yacht broke Transatlantic mono-hull record, arriving from New York to Lizard Point (Great Britain) in 11 days 13:22.58.[49]

In 2000[50] and 2004 second and third generations of “Nicorette” won Sydney to Hobart Yacht Race.

Car race sponsorship[edit]

Jeff Gordon Nicorette DuPont race car

During the 90s Nicorette (GlaxoSmithKline) has been sponsoring Dennis Vitolo (ex-smoker) in Payton Coyne Racing[51] and The Grand Prix of Miami.[52]

In 2005 the brand entered NASCAR race sponsorship with Casey Mears.[53][54]

Since 2006 Nicorette is sponsoring Hendrick Motorsports with Jeff Gordon's car.[55]

The brand also runs the Nicorette's Quit Crew program to help racers quit smoking.[56]

Apparently the brand is supporting car races because NASCAR fans are heavy smokers.[54]

See also[edit]

References[edit]

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External links[edit]