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[Toxicology] GlaxoSmithKline Commit 4 mg nicotine polacrilex lozenges give 6.8 mg aspartame each, up to 136 mg daily; none in Nicorette gum: Murray 2005.05.04

toxicol at iubio.bio.indiana.edu toxicol at iubio.bio.indiana.edu
Thu May 5 15:07:37 EST 2005


http://groups.yahoo.com/group/aspartameNM/message/1167
GlaxoSmithKline Commit 4 mg nicotine polacrilex lozenges give 6.8 mg
aspartame each, up to 136 mg daily;  none in Nicorette gum: Murray
2005.05.04

One lozenge gives as much aspartame as a stick of chewing gum, enough to
trigger severe symptoms in aspartame reactors -- the same symptoms listed
for Commit.

http://www.gsk.com/index.htm
"Do more, feel better, live longer."

UK: +44 (0)20 8047 5000  GSK House, Main Switchboard
US: + 1 888 825 5249
GlaxoSmithKline Consumer Healthcare, Pittsburgh, Pennsylvania, USA,
1000 GSK Drive, Moon Township, PA 15108  412-200-4000

GlaxoSmithKline (GSK) is a world leading research-based pharmaceutical
company with a powerful combination of skills and resources that provides a
platform for delivering strong growth in today's rapidly changing healthcare
environment.
GSK's mission is to improve the quality of human life by enabling people to
do more, feel better and live longer.
Headquartered in the UK and with operations based in the US, the new company
is one of the industry leaders, with an estimated seven per cent of the
world's pharmaceutical market.
GSK also has leadership in four major therapeutic areas - anti-infectives,
central nervous system (CNS), respiratory and gastro-intestinal/metabolic.
In addition, it is a leader in the important area of vaccines and has a
growing portfolio of oncology products.
The company also has a Consumer Healthcare portfolio comprising
over-the-counter (OTC) medicines, oral care products and nutritional
healthcare drinks, all of which are among the market leaders.
Based on 2004 Annual Results, GSK had sales of £20.3 billion ($37.2 billion)
and profit before tax of £6.1 billion ($11.1 billion). Total pharmaceutical
turnover was just over £17 billion ($31 billion) and consumer healthcare
turnover was £3.2 billion ($5.8 billion).
GSK has over 100,000 employees worldwide. Of these, over 40,000 are in sales
and marketing, the largest sales force in the industry. Around 35,000
employees work at 82 manufacturing sites in 37 countries and over 15,000 are
in R&D.
GSK R&D is based at 24 sites in 11 countries. The company has a leading
position in genomics/genetics and new drug discovery technologies. The GSK
R&D budget is about £2.8bn/$5bn.

http://yalenewhavenhealth.org/library/healthguide/en-us/drugguide/topic.asp?hwid=d00316a1

The Commit 2 mg and 4 mg oral lozenges each contain 3.4 mg of phenylalanine.
Individuals with phenylketonuria may need to monitor their intake of this
additive. [ 6.8 mg aspartame  Directions are the same for the gum and for
the lozenges. Nicorette gum uses sorbitol or xylitol, not aspartame -- the
daily limit is twenty 2 mg pieces or ten 4 mg pieces, 40 mg active
ingredient daily. ]


http://www.mypatienteducation.com/nicminflavgu.html
Nicorette mint gum: [ about $ 0.30 per piece ]

Inactive Ingredients:
Gum base,
magnesium oxide,
menthol,
peppermint oil,
sodium bicarbonate,
sodium carbonate,
xylitol, [ sweetener, also in citrus flavor --  Original flavor uses
sorbitol  ]
D&C yellow #10


http://www.prxotc.com/detail.aspx?ID=1167

Precision Service OTC Mail Service Pharmacy

>From the marketers of Nicorette® gum.
Includes User's Guide.
72 Lozenges, 4mg each.
[ $ 0.50 each lozenge ]

For those who smoke their first cigarette within 30 minutes of waking up.
If you smoke your first cigarette more than 30 minutes after waking up, use
Commit 2mg Lozenge.

Indications: Reduces withdrawal symptoms, including nicotine craving,
associated with quitting smoking.

Directions: To increase your success in quitting:
1. You must be motivated to quit.
2. Use Enough - Use at least 9 lozenges of Commit per day during the first 6
weeks.
3. Use Long Enough - Use Commit for the full 12 weeks.
4. Use With a Support Program as directed in the enclosed User's Guide.
5. To remove the lozenge, tear off single unit.
Peel off backing starting at corner with loose edge.
Push lozenge through foil.

If you are under 18 years of age, ask a doctor before use.
Before using this product, read the enclosed User's Guide for complete
directions and other important information.
Stop smoking completely when you begin using the lozenge.
If you smoke your first cigarette more than 30 minutes after waking up, use
2 mg nicotine lozenge.
If you smoke your first cigarette within 30 minutes of waking up, use 4 mg
nicotine lozenge according to the following 12 week schedule:

Weeks 1 to 6 :     1 lozenge every 1 to 2 hours [ 20 per day limit ]
Weeks 7 to 9:      1 lozenge every 2 to 4 hours
Weeks 10 to 12 : 1 lozenge every 4 to 8 hours

Nicotine lozenge is a medicine and must be used a certain way to get the
best results.
Place the lozenge in your mouth and allow the lozenge to slowly dissolve
(about 20-30 minutes).
Minimize swallowing.
Do not chew or swallow lozenge.
You may feel a warm or tingling sensation.
Occasionally move the lozenge from one side of your mouth to the other until
completely dissolved (about 20-30 minutes).
Do not eat or drink 15 minutes before using or while the lozenge is in your
mouth.
To improve your chances of quitting, use at least 9 lozenges per day for the
first 6 weeks.
Do not use more than one lozenge at a time or continuously use one lozenge
after another, since this may cause you hiccups, heartburn, nausea or other
side effects.
Do not use more than 5 lozenges in 6 hours.
Do not use more than 20 lozenges per day. [ 80 mg active ingredient daily ]
Stop using the nicotine lozenges at the end of 12 weeks.
If you still feel the need to use nicotine lozenges, talk to your doctor.

Other information: Phenylketonurics:  Contains Phenylalanine 3.4 mg per
lozenge.
[ This is a dose of aspartame of 6.8 mg, about as much in a stick of
sugarless gum.
Slow absorption through the mouth increases the amount released into the
body.
Many aspartame reactors report their typical severe symptoms from a single
stick of sugarless gum.
The 20 lozenge daily limit gives 136 mg aspartame, over half the dose in a
12 oz can of diet soda. ]
Store at 20-25° C (68-77° F).
Protect from light.

Ingredients:

Active Ingredients in each lozenge:
Nicotine Polacrilex, 4mg (Stop smoking aid)

Inactive Ingredients:
Aspartame, [ 6.8 mg ]
Calcium Polycarbophil,
Flavor,
Magnesium Stearate,
Mannitol,
Potassium Bicarbonate,
Sodium Alginate,
Sodium Carbonate,
Xanthan Gum

Warnings:
Blister packaged for your protection.
Do not use if individual seals are open or torn.
If you are pregnant or breast-feeding, only use this medicine on the advice
of your health care provider.
Smoking can seriously harm your child.
Try to stop smoking without using any nicotine replacement medicine.
This medicine is believed to be safer than smoking.

However, the risks to your child from this medicine are not fully known.

Do not use if you continue to smoke, chew tobacco, use snuff, or use a
nicotine patch or other nicotine-containing products.
Ask a doctor before use if you have heart disease, recent heart attack, or
irregular heartbeat.
Nicotine can increase your heart rate or  high blood pressure not controlled
with medication.
Nicotine can increase your blood pressure.
Ask a doctor or pharmacist before use if you are using a non-nicotine stop
smoking drug, or taking prescription medicine for depression or asthma.
Your prescription dose may need to be adjusted.

Stop use and ask a doctor if  any of the following occurs:
mouth problems,
persistent indigestion,
severe sore throat,
irregular heartbeat or palpitations.

Consult a physician if you get symptoms of nicotine overdose such as
nausea,
vomiting,
dizziness,
diarrhea,
weakness
and rapid heartbeat.

[ All these are common symptoms reported by aspartame reactors. ]

Keep out of reach of children and pets.
Nicotine lozenges may have enough nicotine to make children and pets sick.
If you need to remove the lozenge from your mouth, wrap it in paper and
throw away in the trash.
In case of overdose, get medical help or contact a Poison Control Center
right away.

American Cancer Society® -- GlaxoSmithKline provides an annual grant to the
American Cancer Society for stop smoking education and cancer-related
research in return for the use of their seal.

Commit (T), Committed Quitters®, and associated logo designs and overall
trade dress designs are trademarks owned and/or licensed to GlaxoSmithKline
or its affiliated companies.  ©2002 GlaxoSmithKline
************************************************************

http://www.healthfullifestyle.com/theproducts.cfm?owner=208&subcat=98&cat=6

Nicorette Gum 200 (2 mg) pieces (LESS than 25 cigarettes a day)
[ $ 0.50 per piece ]

The 2mg Nicorette gum is for smokers who smoke less than 25 cigarettes per
day.
Nicorette nicotine gum helps you to stop smoking and reduces cigarette
withdrawal symptoms, including nicotine craving, associated with quitting
smoking.
You can stop smoking completely by using the 12 week Nicorette gum schedule.

For 6 weeks: Chew 1 piece of gum every 1-2 hours.
For 3 weeks: Chew 1 piece of gum every 2-4 hours.
For 3 weeks: Chew 1 piece of gum every 4-8 hours.

Total Program time: 12 weeks
Minimum pieces needed each week: 56 pieces (assuming 8 hours of sleep a
night).
Much cheaper than smoking.
If you follow this program, at the end of 12 weeks you will have stopped
smoking.
Directions: Follow the Stop smoking plan, but when a need for a cigarette
arises, chew another piece.

Nicorette Gum 200 pieces (2mg) $110.00 ($99.00 each, if 2 or more purchased
instead of 1)
************************************************************

From: "jamllmc" <jamllmc at yahoo.com>
To: <aspartame at yahoogroups.com>
Subject: [Aspartame Support] Accidental exposure by reactor
Date: Wednesday, May 04, 2005 6:46 PM

In general, I have a very clean diet.  My real vice was smoking.  I
quit smoking this week, and guess what is in Commit nicotine
polacrilex lozenges?  I used thirteen lozenges before I realized they
were making me sick.  Nicotine withdrawal is bad, but not THAT bad.

My question is how long I can expect to be "symptomatic" (ie wretched)
and if there is anything I can do to speed up the process.

Please do not think I'm being frivolous. It was a small amount, but I
had a big reaction.

I did research to the best of my (impaired)ability

Thank you for your response.

PLEASE TRY AND RECRUIT MEMBERS - SEND THEM TO
http://groups.yahoo.com/group/aspartame/

PRINT OUT THIS FLIER AND HAND IT OUT TO PEOPLE:
http://www.ojinaga.com/aspartame/

CHECK OUT OUR WEBSITE!! http://presidiotex.com/aspartame

FREE ASPARTAME BUMPER STICKER http://ojinaga.com/bumperstickers/freesticker/

to subscribe to this list, send a blank e-mail to:
aspartame-subscribe at yahoogroups.com

Our chat room is at http://pub43.bravenet.com/chat/show.php/3648148879

To visit your group on the web, go to:
http://groups.yahoo.com/group/aspartame/  822 members
18,281 posts in public archive
************************************************************

http://groups.yahoo.com/group/aspartameNM/message/1165
short review: research on aspartame (methanol, formaldehyde, formic acid):
Murray 2005.05.04

Rich Murray, MA  Room For All  rmforall at comcast.net  505-501-2298
1943 Otowi Road    Santa Fe, New Mexico 87505   USA
http://groups.yahoo.com/group/aspartameNM/messages
group with 183 members, 1,167 posts in a public, searchable archive

http://groups.yahoo.com/group/aspartameNM/message/1071
research on aspartame (methanol, formaldehyde, formic acid) toxicity: Murray
2004.04.29 rmforall

http://groups.yahoo.com/group/aspartameNM/message/1143
methanol (formaldehyde, formic acid) disposition: Bouchard M et al, full
plain text, 2001: substantial sources are degradation of fruit pectins,
liquors, aspartame, smoke: Murray 2005.04.02 rmforall

Aspartame (NutraSweet, Equal, Canderel, E951), after eight years of
controversy, was suddenly and capriciously approved by a new FDA
commissioner,  Arthur Hull Hayes, Jr,  just appointed by President Reagan, a
pharmacologist who had been in office less than three months and had little
background in food additives, in July 1981, overturning the vote of his own
Scientific Board of Inquiry.

Aspartame is made of phenylalanine (50% by weight) and aspartic acid (39%),
both ordinary amino acids, bound loosely together by methanol (wood alcohol,
11%).   The readily released methanol from aspartame is within hours turned
by the liver into formaldehyde and then formic acid, both potent, cumulative
toxins.

A team in a Searle Co. lab, led by J.A. Oppermann proved that 30% of the
methanol in aspartame fed to rats remained, indubitably as toxic products of
formaldehyde and formic acid in all tissues (1973, 1976).

http://groups.yahoo.com/group/aspartameNM/message/925
aspartame puts formaldehyde adducts into tissues, Part 1/2
full text, Trocho & Alemany 1998.06.26: Murray 2002.12.22 rmforall

This was confirmed by an expert team at the University of Barcelona (Trocho,
Alemany et al, 1998):
"...the binding of methanol-derived carbon to tissue proteins was
widespread, affecting all systems, fully reaching even sensitive targets
such as the brain and retina...These are indeed extremely high levels for
adducts of formaldehyde, a substance responsible for chronic deleterious
effects (33), that has also been considered carcinogenic (33,47)."

Fully 11% of aspartame is methanol--  1,120 mg aspartame  in 2 L diet soda,
almost six 12-oz cans,  gives 123 mg methanol (wood alcohol).   If 30% of
the methanol is turned into formaldehyde, the amount of formaldehyde is 18
times the EPA limit for daily formaldehyde in drinking water, 2 mg in 2 L
water.

http://groups.yahoo.com/group/aspartameNM/message/1016
President Bush & formaldehyde (aspartame) toxicity: Ramazzini Foundation
carcinogenicity results Dec 2002: Soffritti: Murray 2003.08.03 rmforall

p. 88 "The sweetening agent aspartame hydrolyzes in the gastrointestinal
tract to become free methyl alcohol, which is metabolized in the liver to
formaldehyde, formic acid, and CO2. (11)"
Medinsky MA & Dorman DC. 1994; Assessing risks of low-level methanol
exposure. CIIT Act. 14: 1-7.
Ann N Y Acad Sci. 2002 Dec; 982: 87-105.
Results of long-term experimental studies on the carcinogenicity of
formaldehyde and acetaldehyde in rats.   M. Soffritti et al.  Cancer
Research Center, European Ramazzini Foundation for Oncology and
Environmental Sciences, Bologna, Italy. crcfr at tin.it

http://groups.yahoo.com/group/aspartameNM/message/1077
eight depressed people react strongly to aspartame, Prof. Ralph G. Walton,
MD, 1993 double-blind study, full text: Murray 2004.04.26 rmforall
Despite the very small number of subjects, the results were dramatic and
statistically significant.  The eight depressed patients reported with
aspartame, compared to placebo, much higher levels of nervousness, trouble
remembering, nausea, depression, temper, and malaise.

Many scientific studies and case histories report:  * headaches  * many body
and joint pains (or burning, tingling, tremors, twitching, spasms, cramps,
stiffness, numbness, difficulty swallowing)  *  fever, fatigue, swollen
glands  * "mind fog", "feel unreal", poor memory, confusion, anxiety,
irritability, depression, mania, insomnia, dizziness, slurred speech, sexual
problems,  poor vision, hearing (deafness, tinnitus), or taste  * red face,
itching, rashes, allergic dermatitis, hair loss, burning eyes or throat, dry
eyes or mouth, mouth sores, burning tongue  * obesity, bloating, edema,
anorexia, poor appetite or excessive hunger or thirst    * breathing
problems, shortness of breath * nausea, diarrhea or constipation  * coldness
* sweating  * racing heart, low or high blood pressure, erratic blood sugar
levels  * hypothryroidism or hyperthyroidism  * seizures  * birth defects
*  brain cancers  * addiction  * aggrivates diabetes, autism, allergies,
lupus, ADHD, fibromyalgia, chronic fatigue syndrome, multiple chemical
sensitivity, multiple sclerosis, pseudotumor cerebri and interstitial
cystitis (bladder pain).

http://groups.yahoo.com/group/aspartameNM/message/927
Donald Rumsfeld, 1977 head of Searle Corp., got aspartame FDA approval:
Turner: Murray 2002.12.23 rmforall

http://groups.yahoo.com/group/aspartameNM/message/1045
http://www.holisticmed.com/aspartame/scf2002-response.htm
Mark Gold exhaustively critiques European Commission Scientific Committee on
Food re aspartame ( 2002.12.04 ): 59 pages, 230 references

http://groups.yahoo.com/group/aspartameNM/message/1131
genotoxicity of aspartame in human lymphocytes 2004.07.29 full plain text,
Rencuzogullari E et al, Cukurova University, Adana, Turkey 2004 Aug: Murray
2004.11.06 rmforall

http://groups.yahoo.com/group/aspartameNM/message/1088
Murray, full plain text & critique: chronic aspartame in rats affects
memory, brain cholinergic receptors, and brain chemistry, Christian B,
McConnaughey M et al, 2004 May: 2004.06.05 rmforall

http://groups.yahoo.com/group/aspartameNM/message/1067
eyelid contact dermatitis by formaldehyde from aspartame, AM Hill & DV
Belsito, Nov 2003: Murray 2004.03.30 rmforall

http://groups.yahoo.com/group/aspartameNM/message/1155
continuing aspartame debate in British Medical Journal, John Biffra, Bob
Dowling, Nick Finer, Ian J Gordon: Murray 2005.02.09 rmforall

http://groups.yahoo.com/group/aspartameNM/message/1065
politicians and celebrities hooked on diet sodas (aspartame): Murray
2004.03.24 rmforall

http://google.com  gives 468,000 websites for "aspartame" , with the top 7
of 10 listings being anti-aspartame, while
http://www.ncbi.nlm.nih.gov/PubMed   lists 785 aspartame items.
************************************************************

http://groups.yahoo.com/group/aspartameNM/message/846
RTM: aspartame in Merck Maxalt-MLT worsens migraine,
AstraZeneca Zomig, Eli Lilly Zyprexa,
J&J Merck Pepcid AC (Famotidine 10mg) Chewable Tab,
Pfizer Cool Mint Listerine Pocketpaks 2002.07.16 rmforall
Migraine MLT-Down: an unusual presentation of migraine
in patients with aspartame-triggered headaches.
Newman LC, Lipton RB  Headache 2001 Oct; 41(9): 899-901.
[Merck 10-mg Maxalt-MLT, for migraine, has 3.75 mg aspartame,
while 12 oz diet soda has 200 mg.]
Headache Institute, St. Lukes-Roosevelt Hospital Center, New York, NY
Department of Neurology   newmanache at aol.com
Albert Einstein College of Medicine, Bronx, NY
Innovative Medical Research   RLipton at IMRInc.com

http://groups.yahoo.com/group/aspartameNM/message/855
RTM: Blumenthall & Vance:
aspartame chewing gum headaches Nov 1997 2002.07.28 rmforall
Harvey J. Blumenthal, MD, Dwight A Vance, RPh
Chewing Gum Headaches.
Headache 1997 Nov-Dec; 37(10): 665-6.
Department of Neurology, University of Oklahoma College of Medicine,
Tulsa, USA.   neurotulsa at aol.com
Aspartame, a popular dietetic sweetener, may provoke headache in some
susceptible individuals. Herein, we describe three cases of young women
with migraine who reported their headaches could be provoked by chewing
gum sweetened with aspartame. [6-8 mg aspartame per stick chewing gum]
************************************************************

http://www.visn21.med.va.gov/resources/docs/pharmacy/druginfo/duc/nicotine_lozenge.pdf

REFERENCES:
1. Choi JH, Dresler CM, Norton MR, Strbas KR. Pharmacokinetics of the
nicotine polacrilex lozenge. Nic Tob Res 2003; 5(5): 635-644.

2. Shiffman S, Dresler CM, Hajek P, et al. Efficacy of the nicotine lozenge
for smoking cessation. Arch Intern Med 2002; 162: 1267-1276.

3. Silagy C, Lancaster T, Stead L, Mant D, Fowler G. Nicotine replacement
therapy for smoking cessation (Cochrane review). IN: the Cochrane Library,
Issue 3, 2004.  Chilester, UK: John Wiley & Sons, Ltd.

4. Wallstrom M, sand L, Nilsson F, Hirsch J. The long-term effect of
nicotine on the oral mucosa. Addiction 1999; 94(3): 417-423.

5. Nicotine & Nicotine polacrilex, AFHS Drug Information 2004.

6. Nicotine, Micromedex DRUGDEX and PDR.

7. Clinical Practice Guideline: Treating Tobacco Use and Dependence, U.S.
Department of Health and Human Services, pages 77-78
http://www.surgeongeneral.gov/tobacco/treating_tobacco_use.pdf

8. http://www.oqp.med.va.gov/cpg/TUC/TUC_Base.htm
************************************************************

Tob Control 2001; 10(Suppl 1): i33-i40 ( Winter )
Test of "Light" cigarette counter-advertising using a standard test of
advertising effectiveness
Saul Shiffman a, Steven L Burton b, Janine L Pillitteri c, Joe G Gitchell d,
Michael E Di Marino d, Christine T Sweeney d, Paul A Wardle b, Gary L
Koehler b

a Pinney Associates and University of Pittsburgh, Pittsburgh, Pennsylvania,
USA,
b GlaxoSmithKline Consumer Healthcare, Pittsburgh, Pennsylvania, USA,
1000 GSK Drive, Moon Township, PA 15108  412-200-4000
c Pinney Associates, Seattle, Washington, USA,
d Pinney Associates, Bethesda, Maryland, USA

Correspondence to: Saul Shiffman, PhD, Pinney Associates, 201 North Craig
Street, Suite 320, Pittsburgh, PA 15213, USA shiffman at pinneyassociates.com
 (412) 687-5677


Nicotine Tob Res. 2005 Feb; 7(1): 119-27.
Nicotine patch and lozenge are effective for women.
Shiffman S, Sweeney CT, Dresler CM.
Pinney Associates and University of Pittsburgh, Pittsburgh, PA 15213, USA.
carolyn.m.dresler at sb.com    csweeney at pinneyassociates.com

It has been hypothesized that women may be less likely to obtain therapeutic
benefit from nicotine replacement therapy (NRT).
The present study tested this hypothesis, using two different types of NRT
medications.
A secondary analysis of two randomized clinical trials was performed:
One compared active 21-mg nicotine patch with placebo among 193 men and 309
women, and
the other compared active 2-mg or 4-mg nicotine lozenge with placebo among
788 men and 1,030 women.
Using logistic regression analysis of 6-month continuous abstinence and
survival analysis, we assessed the efficacy of patch and lozenge among women
and tested for a gender x treatment interaction.
Active NRT was more effective than placebo among women, for both patch and
lozenge.
In the lozenge trial, women were less successful than men.
The gender x treatment interaction was not significant in either study,
whether assessed by logistic regression or survival analysis.
In the lozenge trial, gender moderated the effects of smoking rate and
dependence (but not treatment) on outcome:
These variables affected success rates only among women. Treatment with
nicotine patch or lozenge is effective for women, and the analysis did not
reveal significant gender differences in efficacy.
Gender differences in outcome may be moderated by nicotine dependence.
PMID: 15804684

Head, Tobacco Unit, International Agency for Research on Cancer, Lyon,
France.   Carolyn_dresler at ksg03.harvard.edu

Nicotine Tob Res. 2003 Oct; 5(5): 635-44.
Pharmacokinetics of a nicotine polacrilex lozenge.
Choi JH, Dresler CM, Norton MR, Strahs KR.
GlaxoSmithKline Consumer Healthcare, Parsippany NJ 07054-3884, USA.
jae.h.choi at gsk.com     carolyn.m.dresler at sb.com

To evaluate the pharmacokinetic characteristics of the 2-mg and 4-mg
nicotine polacrilex lozenges, the following four separate studies were
conducted in healthy adult smokers:
(a) A single-dose, four-way crossover (replicate design) study to compare
the 4-mg lozenge and the 4-mg nicotine polacrilex gum,
(b) a single-dose, two-way crossover study to compare the 2-mg lozenge and
the 2-mg gum,
(c) a multiple-dose, four-way crossover study to compare the lozenges
administered every 90 min and the gums administered every 60 min at 2- and
4-mg dose levels, and
(d) a single-dose, three-way crossover study to compare the pharmacokinetic
profiles of the 4-mg lozenge when administered in three different ways:
(i) Used as directed,
ii) chewed and immediately swallowed, and
(iii) chewed, retained in the mouth for 5 min, and then swallowed.
The single-dose studies consistently demonstrated 8%-10% higher maximal
plasma concentrations and 25%-27% higher AUC values (area under the
concentration-time curve) from the lozenges compared with the gums at the 2-
and 4-mg dose levels, probably owing to the residual nicotine retained in
the gum.
The multiple-dose study applying different dosing intervals (i.e., every 90
min for the lozenges and every 60 min for the gums) resulted in
approximately 30% lower AUC(0-t) values for the lozenges compared with those
for the gums.
Administration of the lozenge contrary to the label-specified instructions
for use did not lead to a faster or higher absorption of nicotine.
These pharmacokinetic characteristics should allow the lozenge to become an
effective and safe therapeutic alternative for smoking cessation.
Publication Types: Clinical Trial  Randomized Controlled Trial
PMID: 14577980



Arch Intern Med. 2002 Jun 10; 162(11): 1267-76.
Comment in:
Arch Intern Med. 2002 Dec 9-23;162(22):2632-3; author reply 2633.
Efficacy of a nicotine lozenge for smoking cessation.
Shiffman S, Dresler CM, Hajek P, Gilburt SJ, Targett DA, Strahs KR.
Pinney Associates, 201 N Craig St, Suite 320, Pittsburgh, PA 15213, USA.
shiffman at pinneyassociates.com

BACKGROUND: Since nicotine gum was introduced in the 1980s, nicotine
replacement therapy has become the most widely used pharmacological smoking
cessation treatment.
Some smokers prefer acute oral forms, but many smokers reject chewing gum.
We tested the safety and efficacy of a new nicotine polacrilex lozenge for
smoking cessation.
METHODS: Double-blind, placebo-controlled, randomized clinical trial with
parallel arms testing 2- and 4-mg nicotine lozenges.
Smokers (n = 1818) were assigned to a lozenge dose on the basis of nicotine
dependence, assessed by time to the first cigarette of the day.
Low-dependence smokers were randomized to receive the 2-mg nicotine (n =
459) or placebo (n = 458) lozenge;
high-dependence smokers, the 4-mg nicotine (n = 450) or placebo (n = 451)
lozenge.
We assessed abstinence at 6, 12, 24, and 52 weeks and analyzed craving and
withdrawal symptoms.
RESULTS: Treatment with the nicotine lozenge resulted in significantly
greater 28-day abstinence at 6 weeks, for the 2-mg (46.0% vs. 29.7%; odds
ratio [OR], 2.10; 95% confidence interval [CI], 1.59-2.79; P<.001) and the
4-mg (48.7% vs. 20.8%; OR, 3.69; 95% CI, 2.74-4.96; P<.001) lozenges,
compared with placebo.
Significant treatment effects were maintained for a full year.
Smokers who used more lozenges achieved significantly better treatment
effects. Use of the active lozenge also resulted in reduced craving and
withdrawal.
Most adverse events were moderate and resembled those seen with nicotine
gum.
CONCLUSION: The nicotine lozenge is a safe and effective new treatment for
smoking cessation in low- and high-dependence smokers.
Publication Types:   Clinical Trial  Multicenter Study
Randomized Controlled Trial  PMID: 12038945

John R Hughes
University of Vermont, Department of Psychiatry, Burlington, VT 05401, USA.
john.hughes at uvm.edu

M J Carpenter
Department of Psychology, University of Vermont, USA. carpente at musc.edu

Higgins ST, Heil SH, Solomon LJ, Bernstein IM, Lussier JP, Abel RL, Lynch
ME, Badger GJ.
Department of Psychiatry, University of Vermont, Burlington, VT 05401, USA.
stephen.higgins at uvm.edu

Solomon LJ, Flynn BS.
Department of Psychology, University of Vermont, Burlington 05405, USA.
Lsolomon at zoo.uvm.edu

Secker-Walker RH, Flynn BS, Solomon LJ, Skelly JM, Dorwaldt AL, Ashikaga T.
University of Vermont, Burlington, USA. rseckerw at zoo.uvm.edu


Tob Control. 2005 Feb; 14(1): 37-42.
Cost effectiveness of a community based research project to help women quit
smoking.
Secker-Walker RH, Holland RR, Lloyd CM, Pelkey D, Flynn BS.
The Office of Health Promotion Research, University of Vermont, Burlington,
Vermont, USA. roger.secker-walker at uvm.edu
BFlynn at moose.uvm.edu     John.Worden at uvm.edu

alt.support.stop-smoking
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