Nicorette is the brand name of a number of products for
nicotine replacement therapy
Nicotine replacement therapy (NRT) is a medically approved way to treat people with tobacco use disorder by taking nicotine through means other than tobacco. It is used to help with quitting smoking or stopping chewing tobacco. It increases the ...
(NRT) that contain
nicotine polacrilex Nicotine polacrilex is nicotine bound to an ion-exchange resin (polymethacrylic acid, such as Amberlite IRP64, Purolite C115HMR or Doshion P551). It is added to gums and hard lozenges used for nicotine replacement therapy in smoking cessation, part ...
. Developed in the late 1970s in
Sweden
Sweden, formally the Kingdom of Sweden,The United Nations Group of Experts on Geographical Names states that the country's formal name is the Kingdom of SwedenUNGEGN World Geographical Names, Sweden./ref> is a Nordic country located on ...
by in the form of a chewing gum, Nicorette was the first nicotine replacement product on the market.
The product range encompasses chewing gum,
[ (Google Books)][ (Google Books)] lozenges,
patches of two kinds (transparent and non-transparent),
oral spray (Nicorette QuickMist),
inhalator,
sublingual tablets
Sublingual (List of abbreviations used in medical prescriptions, abbreviated SL), from the Latin for "under the tongue", refers to the pharmacological route of administration by which substances diffuse into the blood through Tissue (biology), t ...
(Nicorette Microtab)
and nasal spray.
The products are manufactured by
McNeil Consumer Healthcare
McNeil Consumer Healthcare is an American medicals products company belonging to the Johnson & Johnson Health care, healthcare products group. It primarily sells fast-moving consumer goods such as Over-the-counter drug, over-the-counter drugs.
...
company, a subsidiary of
Johnson & Johnson
Johnson & Johnson (J&J) is an American multinational corporation founded in 1886 that develops medical devices, pharmaceuticals, and consumer packaged goods. Its common stock is a component of the Dow Jones Industrial Average and the company i ...
, in Helsingborg, Sweden and are sold globally by Johnson & Johnson, even in the Middle East, except for in the United States where Nicorette is distributed by
Haleon
Haleon plc is a British multinational consumer healthcare company with headquarters in Weybridge, England. It is the largest consumer healthcare business in the world, with brands including Sensodyne toothpaste, Panadol
Paracetamol, also kno ...
.
Nicotine replacement products including gum and
transdermal patch
A transdermal patch is a medicated adhesive patch that is placed on the skin to deliver a specific dose of medication through the skin and into the bloodstream. An advantage of a transdermal drug delivery route over other types of medicat ...
es are on the
World Health Organization's List of Essential Medicines
The WHO Model List of Essential Medicines (aka Essential Medicines List or EML), published by the World Health Organization (WHO), contains the medications considered to be most effective and safe to meet the most important needs in a health ...
.
The brand name "Nicorette" comes from "nicotine" and sv, rette, "right way".
Medical uses
Nicorette products are indicated for the relief of
withdrawal symptoms
Drug withdrawal, drug withdrawal syndrome, or substance withdrawal syndrome, is the group of symptoms that occur upon the abrupt discontinuation or decrease in the intake of pharmaceutical or recreational drugs.
In order for the symptoms of with ...
associated with
nicotine withdrawal
Nicotine withdrawal is a group of symptoms that occur in the first few weeks after stopping or decreasing use of nicotine. Symptoms include intense cravings for nicotine, anger or irritability, anxiety, depression, impatience, trouble sleeping, ...
and to aid in
smoking cessation
Smoking cessation, usually called quitting smoking or stopping smoking, is the process of discontinuing tobacco smoking. Tobacco smoke contains nicotine, which is addictive and can cause dependence. As a result, nicotine withdrawal often make ...
.
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
The Committee on Safety of Medicines (CSM) was an independent advisory committee that advised the UK Licensing Authority on the quality, efficacy, and safety of medicines.
Following the thalidomide tragedy of 1957 to 1961, in 1963 the government ...
(since 2005, the
Commission on Human Medicines The Commission on Human Medicines (CHM) is a committee of the UK's Medicines and Healthcare products Regulatory Agency. It was formed in October 2005, and assumed the responsibilities of the Medicines Commission and the Committee on Safety of Medi ...
) 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
Irritability (also called as crankiness) is the excitatory ability that living organisms have to respond to changes in their environment. The term is used for both the physiological reaction to stimuli and for the pathological, abnormal or excessi ...
, 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, 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.
Contraindications
The typical contraindication (reason to not use) for Nicorette products is hypersensitivity to nicotine.
Up until recently
cardiovascular disease
Cardiovascular disease (CVD) is a class of diseases that involve the heart or blood vessels. CVD includes coronary artery diseases (CAD) such as angina and myocardial infarction (commonly known as a heart attack). Other CVDs include stroke, h ...
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
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
(FDA) stated that the contraindication concerning usage of NRT products while smoking is no longer valid.
The FDA approved
labeling
Labelling or using a label is describing someone or something in a word or short phrase. For example, the label "criminal" may be used to describe someone who has broken a law. Labelling theory is a theory in sociology which ascribes labelling ...
for Nicorette products with a warning concerning
pregnancy
Pregnancy is the time during which one or more offspring develops ( gestates) inside a woman's uterus (womb). A multiple pregnancy involves more than one offspring, such as with twins.
Pregnancy usually occurs by sexual intercourse, but ca ...
and
breastfeeding
Breastfeeding, or nursing, is the process by which human breast milk is fed to a child. Breast milk may be from the breast, or may be expressed by hand or pumped and fed to the infant. The World Health Organization (WHO) recommends that br ...
: "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
Nausea is a diffuse sensation of unease and discomfort, sometimes perceived as an urge to vomit. While not painful, it can be a debilitating symptom if prolonged and has been described as placing discomfort on the chest, abdomen, or back of the ...
,
vomiting
Vomiting (also known as emesis and throwing up) is the involuntary, forceful expulsion of the contents of one's stomach through the mouth and sometimes the Human nose, nose.
Vomiting can be the result of ailments like Food-poisoning, foo ...
, dizziness, weakness, and rapid heartbeat)
or skin redness caused by the patch.
Formats
Gum
Nicorette chewing gum releases nicotine while chewing. Nicotine then is absorbed across the
oral mucosa
The oral mucosa is the mucous membrane lining the inside of the mouth. It comprises stratified squamous epithelium, termed "oral epithelium", and an underlying connective tissue termed ''lamina propria''. The oral cavity has sometimes been descri ...
into the
systemic circulation
The blood circulatory system is a system of organs that includes the heart, blood vessels, and blood which is circulated throughout the entire body of a human or other vertebrate. It includes the cardiovascular system, or vascular system, tha ...
. 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.
[(Google Books)]
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.
It is suggested to use gum following a 12-week schedule, reducing the amount of gums consumed by the end of the therapy.
Patch
The patches provide slow absorption of nicotine into blood within the day and work for 16 hours.
[(Google Books)] 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.
Microtab
Microtab supplies nicotine to the body by mouth. 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
minute
The minute is a unit of time usually equal to (the first sexagesimal fraction) of an hour, or 60 seconds. In the UTC time standard, a minute on rare occasions has 61 seconds, a consequence of leap seconds (there is a provision to insert a nega ...
s).
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
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably ...
recommends not to exceed 40 tablets per day limit. Treatment should be stopped when daily consumption is around 1-2 tablets per day.
Spray
![Nicorette QuickMist Spray](https://upload.wikimedia.org/wikipedia/commons/9/9d/Nicorette_QuickMist_Spray.jpg)
A spray of nicotine is available.
Tentative evidence supports that it is better than a placebo.
[ 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.]
History
Nicotine gum
The Nicorette brand started with a nicotine chewing gum developed in Helsingborg
Helsingborg (, , , ) is a city and the seat of Helsingborg Municipality, Scania (Skåne), Sweden. It is the second-largest city in Scania (after Malmö) and ninth-largest in Sweden, with a population of 113,816 (2020). Helsingborg is the cent ...
(Sweden
Sweden, formally the Kingdom of Sweden,The United Nations Group of Experts on Geographical Names states that the country's formal name is the Kingdom of SwedenUNGEGN World Geographical Names, Sweden./ref> is a Nordic country located on ...
) by the company Leo AB, later part of Pharmacia & Upjohn
Pharmacia & Upjohn was a global pharmaceutical company formed by the merger of Sweden-based Pharmacia AB and the American company The Upjohn Company, Upjohn in 1995. Today the remainder of the company is owned by Pfizer. In 1997, Pharmacia & Upjo ...
. It was the first product for nicotine replacement therapy
Nicotine replacement therapy (NRT) is a medically approved way to treat people with tobacco use disorder by taking nicotine through means other than tobacco. It is used to help with quitting smoking or stopping chewing tobacco. It increases the ...
and gained its inventor, Ove Fernö, titles like "the founding father of modern pharmacotherapy for smoking".
On December 12, 1967, Fernö, Vice President of Research and Development at AB Leo, received a mail from his friend Dr. Claes Lundgren at the Department of Aviation Medicine at the Physiological Institute of Lund University
, motto = Ad utrumque
, mottoeng = Prepared for both
, established =
, type = Public research university
, budget = SEK 9 billion [cigarette
A cigarette is a narrow cylinder containing a combustible material, typically tobacco, that is rolled into thin paper for smoking. The cigarette is ignited at one end, causing it to smolder; the resulting smoke is orally inhaled via the opp ...]
s to chewing tobacco
Chewing tobacco is a type of smokeless tobacco product that is placed between the cheek and lower gum to draw out its flavor. Some users chew it, others do not. It consists of coarsely chopped aged tobacco that is flavored and often sweetened; ...
and snus
Snus ( , ) is a tobacco product, originating from a variant of dry snuff in early 18th-century Sweden. It is placed between the upper lip and gum for extended periods, as a form of sublabial administration. Snus is not fermented. Although used s ...
when smoking was not possible. They also suggested the product name "Nicorette". Fernö began experimenting with nicotine gum in 1969, and quit smoking himself after one year of use.
The first nicotine chewing gum was produced at AB Leo in 1971. The innovation was in the use of ion-exchange resin
An ion-exchange resin or ion-exchange polymer is a resin or polymer that acts as a medium for ion exchange. It is an insoluble matrix (or support structure) normally in the form of small (0.25–1.43 mm radius) microbeads, usually white or ye ...
( 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". 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. His findings were presented at the Second World Conference on Smoking and Health in London 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
The Institute of Psychiatry, Psychology and Neuroscience (IoPPN) is a research institution dedicated to discovering what causes mental illness and diseases of the brain. In addition, its aim is to help identify new treatments for them and ways ...
, 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
The Department of Health and Social Security (commonly known as the DHSS) was a ministry of the British government in existence for twenty years from 1968 until 1988, and was headed by the Secretary of State for Health and Social Services.
His ...
.
Nicorette was registered as a drug in Switzerland in 1978, in Canada in 1979, and in the UK in 1980. It was registered in Sweden in 1981. Initially the Swedish Medical Products Agency
The Medical Products Agency (MPA; sv, Läkemedelsverket) is the government agency in Sweden responsible for regulation and surveillance of the development, manufacturing and sale of medicinal drugs, medical devices and cosmetics.
Its task is al ...
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.
On January 13, 1984, Nicorette chewing gum was approved by the US Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
after a 34-month review. It was brought to the US market by Marion Merrell Dow
Marion Merrell Dow and its predecessor Marion Laboratories was a U.S. pharmaceutical company based in Kansas City, Missouri from 1950 until 1996.
The company specialized in bringing to market drugs that had been discovered but unmarketed by other ...
under licence from AB Leo.
In 2016, it was the third biggest selling branded over-the-counter medication sold in Great Britain, with sales of £66.0 million.
Further product
The Nicorette Patch
Patch or Patches may refer to:
Arts, entertainment and media
* Patch Johnson, a fictional character from ''Days of Our Lives''
* Patch (''My Little Pony''), a toy
* "Patches" (Dickey Lee song), 1962
* "Patches" (Chairmen of the Board song) ...
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
Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, as opposed to prescription drugs, which may be supplied only to consumers possessing a valid prescr ...
status in the US.
The Nicorette inhaler was launched in 1996 and Nicorette Microtab (sublingual tablets
Sublingual (List of abbreviations used in medical prescriptions, abbreviated SL), from the Latin for "under the tongue", refers to the pharmacological route of administration by which substances diffuse into the blood through Tissue (biology), t ...
) in 1999.
In 2002, the FDA changed the status of Commit lozenges to over the counter in the US.
In 2004, Nicorette launched Peppermint, the first coated nicotine gum. A shell coating containing a sugar substitute (xylitol
Xylitol is a chemical compound with the formula , or HO(CH2)(CHOH)3(CH2)OH; specifically, one particular stereoisomer with that structural formula. It is a colorless or white crystalline solid that is freely soluble in water. It can be classifie ...
) 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
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably ...
, 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
Menthol is an organic compound, more specifically a monoterpenoid, made synthetically or obtained from the oils of corn mint, peppermint, or other mints. It is a waxy, clear or white crystalline substance, which is solid at room temperature and ...
taste.
At the end of November 2010, Nicorette introduced QuickMist 1 mg mouthspray, which provides more rapid absorption of nicotine than lozenges or gum.
In January 2011, Nicorette UK launched the ActiveStop mobile app
A mobile application or app is a computer program or software application designed to run on a mobile device such as a phone, tablet, or watch. Mobile applications often stand in contrast to desktop applications which are designed to run on d ...
for iOS
iOS (formerly iPhone OS) is a mobile operating system created and developed by Apple Inc. exclusively for its hardware. It is the operating system that powers many of the company's mobile devices, including the iPhone; the term also includes ...
featuring target setting, a wish list, distractions, achievement sharing, information and games.
Brand communication
Yacht race sponsorship
Nicorette has been sponsoring yacht racing
Yacht racing is a Sailing (sport), sailing sport involving sailing yachts and larger sailboats, as distinguished from dinghy racing, which involves open boats. It is composed of multiple yachts, in direct competition, racing around a course marke ...
since 1993 when it partnered with Ludde Ingvall
Ludvig "Ludde" Ingvall (born 8 January 1956) is a Finnish-Australian sailor competing in offshore races.
Career
In his youth, Ingvall sailed in the Flying Junior, 420 (dinghy), 420 and 505 (dinghy), 505 classes. He participated in the 1985–86 W ...
, a Finnish-born Swede who started a non-smoking team in 1991.
In 1995, the Nicorette team was banned from the Cape to Rio Race, sponsored by the tobacco company Rothmans Rothmans may refer to:
* Rothmans, Benson & Hedges, a Canadian tobacco company
* Rothmans International, a former British tobacco manufacturer, founded by Louis Rothman
See also
* Rothman, a surname
* Rothmans 12 hours, a series of sports car ra ...
. 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
The Fastnet Race is a biennial offshore yacht race organised by the Royal Ocean Racing Club of the United Kingdom with the assistance of the Royal Yacht Squadron in Cowes and the City of Cherbourg in France.
The race is named after the Fastnet ...
.
In 1997, the yacht broke the Transatlantic mono-hull record, covering the route from New York City
New York, often called New York City or NYC, is the List of United States cities by population, most populous city in the United States. With a 2020 population of 8,804,190 distributed over , New York City is also the L ...
to Lizard Point (Great Britain
Great Britain is an island in the North Atlantic Ocean off the northwest coast of continental Europe. With an area of , it is the largest of the British Isles, the largest European island and the ninth-largest island in the world. It is ...
) in 11 days 13:22.58. Second and third generations of the yacht won the Sydney to Hobart Yacht Race
The Rolex Sydney Hobart Yacht Race is an annual event hosted by the Cruising Yacht Club of Australia, starting in Sydney, New South Wales, on Boxing Day and finishing in Hobart, Tasmania. The race distance is approximately . The race is run i ...
in 2000 and 2004.
Car race sponsorship
During the 90s Nicorette (GlaxoSmithKline
GSK plc, formerly GlaxoSmithKline plc, is a British multinational pharmaceutical and biotechnology company with global headquarters in London, England. Established in 2000 by a merger of Glaxo Wellcome and SmithKline Beecham. GSK is the ten ...
) sponsored Dennis Vitolo
Dennis Vitolo (born December 18, 1956) is an American former race driver who competed in the CART series. He raced in the 1988 and 1991-1999 seasons with 36 career starts, including the 1994 Indianapolis 500. He was involved in a crash in that r ...
(ex-smoker) in Payton Coyne Racing and The Grand Prix of Miami. In 2005, the brand entered NASCAR
The National Association for Stock Car Auto Racing, LLC (NASCAR) is an American auto racing sanctioning and operating company that is best known for stock car racing. The privately owned company was founded by Bill France Sr. in 1948, and hi ...
race sponsorship with Casey Mears
Casey James Mears (born March 12, 1978) is an American professional off-road and stock car racing driver. He has raced in IndyCar, NASCAR's three national series including 15 seasons in the Cup Series, SCORE International, and the Stadium Super T ...
. Since 2006, Nicorette is sponsoring Hendrick Motorsports
Hendrick Motorsports (HMS) is an American professional auto racing organization that competes in the NASCAR Cup Series. The team was founded in 1984 as All Star Racing by Rick Hendrick. Hendrick Motorsports has won a NASCAR-record 291 Cup Seri ...
with Jeff Gordon
Jeffery Michael Gordon (born August 4, 1971) is an American former professional stock car racing driver, who is the Vice Chairman for Hendrick Motorsports. He raced full-time from 1993 to 2015, driving the No. 24 Chevrolet for Hendrick M ...
's car. The brand also runs the Nicorette's Quit Crew program to help racers quit smoking.
It was reported that the brand supports car races because NASCAR fans are heavy smokers.
References
External links
*
*
{{Portal bar , Medicine
Smoking cessation
Haleon
Johnson & Johnson brands