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Nicorette

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Nicorette

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 .com.nicorettewww

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.[1]

The Nicorette product range encompasses 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 patches are on the WHO Model List of Essential Medicines.[10]

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

Contents

  • History 1
    • Nicotine gum development 1.1
    • Further product development 1.2
  • Mechanism of action 2
  • Therapeutic indications 3
  • Contraindications 4
  • Mechanism of action, formats, dosages and administration 5
    • Chewing gum 5.1
    • Invisi Patch 5.2
    • Microtab 5.3
    • QuickMist spray 5.4
  • Brand communication 6
    • Yacht race sponsorship 6.1
    • Car race sponsorship 6.2
  • See also 7
  • References 8
  • External links 9

History

Nicotine gum development

The Nicorette brand started with a nicotine chewing gum developed in Sweden) by the company Leo AB, 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]

On December 12, 1967,[13][14]:1216 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 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".[11]:145

Fernö began experimenting with nicotine gum in 1969 and quit smoking himself after one year of use.[14]:1218

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".[14]: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[11]:146 and were published in 1973 in the journal Psychopharmacologia together with an article by Fernö.[15][16]

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.[11]:147

Nicorette was registered as a drug in Switzerland in 1978, in Canada in 1979, and in the UK in 1980.[11]: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.[17]

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 licence from AB Leo.[18]

Further product development

Nicorette Nasal spray
Nicorette inhaler

The Nicorette Patch was introduced to the market in 1991[19] and the nasal spray in 1994.[20]

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.[21]

The Nicorette inhaler was launched in 1996[20] and Nicorette Microtab (sublingual tablets) in 1999.[22]

In 2002 the FDA changed the status of Commit lozenges to over the counter in the US.[21]

In 2004 Nicorette launched Peppermint, the first coated nicotine gum.[20] A shell coating containing a sugar substitute (xylitol) and flavouring masks the nicotine taste.[23][24] In 2005 Nicorette introduced Fresh Mint chewing gum.[25]

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

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

At the end of November 2010 Nicorette introduced QuickMist 1 mg mouthspray,[28] which provides more rapid absorption of nicotine than lozenges or gum.[29]

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

Mechanism of action

The nicotine from Nicorette replaces some of the nicotine the smoker previously obtained from tobacco smoke; this relieves some of the craving and withdrawal symptoms, and allows the ex-smoker to concentrate on overcoming the habit 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 and carbon monoxide and other gases.

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.

The full dose of Nicorette should be used for about eight weeks, and then the dose can gradually be reduced before treatment stops.

Therapeutic indications

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 (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.[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

The typical contraindication (reason to not use) for Nicorette products is hypersensitivity to nicotine.[32][34]

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.[37]

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

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".[39] The FDA suggests not using Nicorette products if the patient continues to smoke, or use chewing tobacco, snuff or other nicotine-containing products.[39]

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[39] and lozenges), or an allergy to adhesive tape or skin problems (for patches).[40]

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)[39] or skin redness caused by the patch.[40]

Mechanism of action, formats, dosages and administration

Chewing gum

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

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: 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.[43]

Microtab

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]

QuickMist spray

Nicorette QuickMist spray at the pharmacy (France)

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).[28] 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.

Spray is administered when one has a desire to smoke. MHRA suggests not to use more than 2 sprays at a time, up to 4 sprays per hour and no more than 64 sprays per 24 hours period.[28]

Nicorette Quickmist is considered to be the most advanced format of nicotine replacement therapy[46] 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.[47][48] 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).[46]

Brand communication

Yacht race sponsorship

Nicorette is sponsoring yacht racing since 1993[49] when it partnered with Ludde Ingvall, Finnish-born Swede, who started a non-smoking team in 1991.[49]

In 1995 Nicorette team was banned from

  • Nicorette International
  • Nicorette Quit Support
  • Nicorette UK

External links

  1. ^ a b Karl Fagerstöm, Anders Axelsson, Lennart Sorelius. "In memoriam of Ove Fernö - the inventor or NRT and The Past, Present, and Future of NRT". Society for Research on Nicotine and Tobacco Newsletter, September/October 2008, vol. 14, № 3. Archived from the original (PDF) on 2014-12-25. Retrieved 2014-12-25. During the late 1960s and 70s he was responsible for the development of the first NR product – a chewing gum 
  2. ^ "Nicotine replacement therapy". Nurse Prescribers' Formulary for Community Practitioners. Pharmaceutical Press. 2013. p. 16.   (Google Books)
  3. ^ a b c d e f "4.10.2 Nicotine dependence: Nicotine". BNF for Children (BNFC) 2014-2015. Pharmaceutical Press. 2014. p. 244.   (Google Books)
  4. ^ a b Edney, Anna (2014-06-12). "E-Cigarettes May Get Advantage for Not Containing Tobacco".  
  5. ^ a b c d Higgins, Andrew (2013-11-09). "Aided by Army of ‘Vapers,’ E-Cigarette Industry Woos and Wins Europe". Brussels:  
  6. ^ Norton, Amy (2012-02-27). "Nicotine quick-fix mouth spray helps some quitters". New York:  
  7. ^ Magee, Anna (2011-10-20). "What TWO glasses of wine a day can do to your face in ten years".  
  8. ^ Rutter, Paul (2013). "Nicorette". Community Pharmacy: Symptoms, Diagnosis and Treatment. Elsevier Health Sciences. p. 320.  
  9. ^ Kitamura, Makiko (2014-02-19). "Glaxo Memo Shows Drug Industry Lobbying on E-Cigarettes".  
  10. ^ "WHO Model List of Essential Medicines 18th list (April 2013) (Final Amendments – October 2013)".  
  11. ^ a b c d e Larsson, Bengt; Letell, Martin; Thörn, Håkan (2012). "9.5 The rise of medicinal nicotine in Sweden". Transformations of the Swedish Welfare State: From Social Engineering to Governance? (1st ed.). Palgrave Macmillan.  
  12. ^ West, Robert (2008). "Pillars of Smoke". In Edwards, Griffith. Addiction: Evolution of a Specialist Field (1st ed.). John Wiley & Sons. p. 231.  (Google Books)
  13. ^ Raw, Martin (2012). "Who invented NRT". How To Stop Smoking And Stay Stopped (1st ed.). Random House. p. 79.  
  14. ^ a b c d "JOURNAL INTERVIEW—35: Conversation with Ove Ferno". Addiction, 89. 1994. pp. 1215–1226. Archived from the original on 2015-01-05. Retrieved 2015-01-05. 
  15. ^ Brantmark B, Ohlin P, Westling H. (1973-07-19). "Nicotine-containing chewing gum as an anti-smoking aid.". Psychopharmacologia 31 (3): 191–200.  
  16. ^ Fernö O. (1973-07-19). "A substitute for tobacco smoking.". Psychopharmacologia 31 (3): 201–204.  
  17. ^ Kalkhoff, Will; Thye, Shane R.; Lawler, Edward J. (2012). "The Birth of Medicinal Nicotine". Critical Perspectives on Addiction (1st ed.). Emerald Group Publishing. p. 79.  
  18. ^ "Merrell Dow Nicorette Anti-Smoking Rx Chewing Gum Trade Shipments". The Pink Sheet. 1984-01-23. Archived from the original on 2015-01-05. Retrieved 2015-01-05. 
  19. ^ "COMPANY NEWS; Nicotine Patch Marketing Deals".  
  20. ^ a b c d "Nicorette".  
  21. ^ a b "Now Available Without a Prescription".  
  22. ^ "P&U launches sublingual NRT".  
  23. ^ Prashant, K. Pagare; Chandrakant, S. Satpute; Varsha, M. Jadhav; Vilasrao, Kadam (2012-06-23). "Medicated Chewing Gum: A Novel Drug Delivery System". Journal of Applied Pharmaceutical Science 02 (06): 40–54.  
  24. ^ Gad, Shayne Cox, ed. (2008). Pharmaceutical Manufacturing Handbook: Production and Processes. John Wiley & Sons. p. 259.  
  25. ^ Hendrix, Jerry; Hayes, Darrell (2009). "Exhibit 8-4a". Public Relations Cases (8 ed.). Cengage Learning. p. 300.  
  26. ^ a b "Nicorette Invisi 10mg, 15mg, 25mg patches - PL 15513/0159-61".  
  27. ^ "Gum ad screened during The Simpsons ‘inappropriate’".  
  28. ^ a b c "Nicorette Quickmist 1mg/spray Mouthspray - PL 15513/0357".  
  29. ^ Chaplin, Steve (July 2011). "Nicorette QuickMist: rapidly absorbed NRT mouthspray" 22 (13-14). Prescriber.  
  30. ^ Ratcliffe, Jack (2011-01-05). "Nicorette's ActiveStop anti-cigarette iPhone app". Latestgadgets.co.uk. Archived from the original on 2014-12-31. Retrieved 2014-12-31. 
  31. ^ "New iPhone app launched to help smokers quit".  
  32. ^ a b c "Nicorette Invisi 10 mg patch, Nicorette Invisi 15 mg patch, Nicorette Invisi 25 mg patch, PL 15513/0159-61".  
  33. ^ a b c "MHRA Public Assessment Report: The use of nicotine replacement therapy to reduce harm in smokers, February 2010".  
  34. ^ a b "Nicorette Peppermint 2 and 4 mg gum, Nicorette Ice Mint 2 and 4 mg gum, Nicorette Spearmint 2 and 4 mg gum, PL 15513/0136-7, PL 15513/0143-4, PL 15513/0152-3".  
  35. ^ "Report of the Committee on Safety of Medicines Working Group on Nicotine Replacement Therapy, November 2005" (PDF).  
  36. ^ David C. Dugdale, III. "Nicotine replacement therapy". MedlinePlus. U.S. National Library of Medicine. Archived from the original on 2015-01-09. Retrieved 2015-01-09. 
  37. ^ "Nicotine is not a significant risk factor for cardiovascular events. The benefit of nicotine replacement therapy outweighs the risks of nicotine medication, even in smokers with cardiovascular disease". The Society for Research on Nicotine and Tobacco (SRNT). 2014-12-16. Archived from the original on 2015-01-09. Retrieved 2015-01-09. 
  38. ^ "Nicotine Replacement Therapy Labels May Change".  
  39. ^ a b c d e f "Nicorette, Nicotine Polacrilex, Labeling Revision 10/30/2014".  
  40. ^ a b "Nicoderm, Labeling Revision 10/30/2014".  
  41. ^ a b c Burchum, Jacqueline; Rosenthal, Laura (2014). "Chapter 39: Drug Abuse III: Nicotine and Smoking". Lehne's Pharmacology for Nursing Care. Elsevier Health Sciences. p. 427.  (Google Books)
  42. ^ a b c Rutter, Paul (2013). "Nicorette". Community Pharmacy: Symptoms, Diagnosis and Treatment (3 ed.). Elsevier Health Sciences. p. 320.  (Google Books)
  43. ^ "New high-strength nicotine patch".  
  44. ^ a b Willis, Nicola (2012). "Which Treatment?". Stop! No Smoking Programme. Random House. p. 69.  
  45. ^ "Public Assessment Report: Nicorette Microtab Lemon 2mg sublingual tablets. Nicotine bitartrate dihydrate, PL 15513/0156".  
  46. ^ a b Tønnesen, Philip; Lauri, Hans; Perfekt, Roland; Mann, Karl; Batra, Anil (February 9, 2012). "Efficacy of a nicotine mouth spray in smoking cessation: a randomised, double-blind tria" (PDF). European Respiratory Journal (European Respiratory Society) 40 (3): 548–54.  
  47. ^ "Spray your way to a smoke-free New Year". Easier.com. 2012-01-05. Archived from the original on 2015-07-01. Retrieved 2015-07-01. 
  48. ^ Gallagher, Tony (2011-05-04). "Lifecoach: I'm putting on weight but can't face the gym".  
  49. ^ a b c Coomber, John (2004-12-23). "New super maxi a smoke-free zone: Ludde Ingvall reckons his new super maxi Nicorette goes so fast you can almost see the hull smoking". http://www.racingandsports.com.au. Racing and Sports. Archived from the original on 2015-01-23. Retrieved 2015-01-23. 
  50. ^ Coakley, Jay J.; Dunning, Eric (2000). "Sport and Health". Handbook of Sports Studies (1st ed.). SAGE. p. 411.  (Google Books)
  51. ^ Hammond, Ross (2000-01-07). "Tobacco Advertising & Promotion: The Need for a Coordinated Global Response". New Delhi:  
  52. ^ "PLUS: YACHT RACING; Frenchman Breaks Trans-Atlantic Mark".  
  53. ^ Tait, Paul (2000-12-29). "Rough rider Nicorette takes Sydney-Hobart".  
  54. ^ Schlotter, Bill (1997-09-26). "MOTOR SPORTS : DRIVING OFF TOBACCO ROAD.(SPORTS)".  
  55. ^ "MARKETING: Breaking Away From the Packs".  
  56. ^ "NASCAR leaves smoking days farther behind".  
  57. ^ a b Horovitz, Bruce (2005-01-26). "Nicorette, NASCAR sign sponsorship deal".  
  58. ^ "Nicorette to Join No. 24 Team in 2006". Hendrickmotorsports.com. 2005-10-14. Archived from the original on 2015-01-01. Retrieved 2015-01-01. 
  59. ^ Coble, Don (2007-04-10). "Nicorette gum helps NASCAR shift gear on smoking sponsors".  

References

See also

Apparently the brand is supporting car races because NASCAR fans are heavy smokers.[57]

The brand also runs the Nicorette's Quit Crew program to help racers quit smoking.[59]

Since 2006 Nicorette is sponsoring Hendrick Motorsports with Jeff Gordon's car.[58]

In 2005 the brand entered NASCAR race sponsorship with Casey Mears.[56][57]

During the 90s Nicorette (GlaxoSmithKline) has been sponsoring Dennis Vitolo (ex-smoker) in Payton Coyne Racing[54] and The Grand Prix of Miami.[55]

Jeff Gordon Nicorette DuPont race car

Car race sponsorship

In 2000[53] and 2004 second and third generations of “Nicorette” won Sydney to Hobart Yacht 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.[52]

. Fastnet Race In the same year the yacht won [51]

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