Fact sheet
Nicotine
Peppermint
medicated chewing gum
The gum
Quitt® nicotine gum is a new chewing gum developed for nicotine replacement therapy (NRT) by Fertin Pharma, the world’s leading B2B manufacturer of
NRT chewing gum. The gum is available in mint and
lemon flavors, 2mg and 4mg strengths, in a wide variety of pack count formats. Quitt® comes in a coated, extruded form, the formula is based on Nicotine Polacrilex, and it is bioequivalent to Nicorette.
Tobacco consumption
Cited as a major public health threat by the WHO,
smoking is the cause of several serious health conditions such as: cardiovascular disease, cancer and
respiratory diseases. Put into perspective, tobacco
accounts for one in every ten deaths worldwide and
one fatality every six seconds1.
Nicotine replacement therapy
NRT is a treatment that uses small steady doses of
nicotine to help stop nicotine cravings and symptoms that occur while a person is attempting to
quit smoking. Thus it is a treatment that allows the
smoker to abstain from tobacco use and thereby
avoid the dangerous carcinogens and toxic gases
from smoke. NRT helps overcome the addiction
of nicotine at a gradual rate, which makes quitting
easier.
In addition NRT is recommended by doctors and
supported by the WHO in fighting the global tobacco epidemic.
Nicotine chewing gum
Currently, several dosage forms are available for
NRT apart from gum such as; lozenges, patches,
inhalers and sprays. So why choose gum?
From a consumer perspective, chewing gum is a
discrete dosage form that tastes good, is widely accepted and consumed routinely in its confectionery
form. From a technical perspective, local delivery in
the mouth enables fast uptake of nicotine by buccal absorption. From a market perspective, chewing gum is the most preferred delivery system within
the NRT category with approximately half of the category share2, growing annually at a rate of 3.1%7
(3-year CAGR).
Nicotine substitution
In some instances smokers require alternative
sources of nicotine other than cigarettes (e.g., due
to non-smoking environments or if smoking is not
tolerated). In these situations the smoker does not
intend to quit, but merely needs a substitute to aid
in suppressing nicotine cravings. Nicotine-containing products like chewing gum can be used occasionally to hinder such cravings.
Safety
The safety of Nicotine polacrilex chewing gum has
been assessed thoroughly and results show that it is
safe if used as instructed and unrelated to any cardiovascular illnesses or other serious side effects5.
Potentials
Currently, NRT is well-established in many parts of
the world including the United States, Scandinavia
and the United Kingdom, but a sizeable untapped
global market still remains.
As local authorities continue to grasp the economic and societal burden caused by tobacco-related illness and disease, their commitment to antismoking initiatives increases.
Studies have concluded that NRT increases the
chances of stopping smoking by 50-70%3,4,5.
References
1. World Health Organisation (http://www.who.int/tobacco/mpower/tobacco_facts/en/) 2. IMS Health NRT data (which year) 3. Cohcrane review: Can nicotine replacement therapy (NRT) help people quit smoking? First published: November 14,
2012; This version published: 2012; Review content assessed as up-to-date: September 19, 2012. 4. C. Silagy et al (1994): Meta-analysis on efficacy of nicotine replacement therapies in smoking cessation. The Lancet, Volume 343, Issue 8890,
Pages 139 - 142, 15 January 1994 5. Murray, R.P. (1996): Safety of nicotine polacrilex gum used by 3,094 participants in the Lung Health Study. Lung Health Study Research Group. Chest. 1996 Feb;109(2):438-45. 6. Nicorette (http://nicorette.
co.uk/help-and-support/smoking-facts) 7. IMS Health NRT data.
Product information
Quick facts
» Bioequivalent to Nicorette
» Available in mint and lemon flavors
» Two strengths (2mg and 4mg)
» Extruded chewing gum technology
» Coated
» Marketing Authorization Holder is
Fertin Pharma
API content
1 piece of Quitt® 2mg/4mg chewing gum contains
13.2mg/26.5mg nicotine resinate corresponding to
2mg/4mg nicotine.
Therapeutic indications
Developed for the treatment of tobacco dependence by relieving nicotine withdrawal symptoms,
Quitt® 2mg/4mg chewing gum functions as an aid
to smoking cessation. Although complete cessation
of tobacco use is preferred, this medicinal product
may be used in: (1) cases where a smoker temporarily abstains from smoking (2) a strategy for reducing
nicotine consumption (smoking reduction) as a step
towards complete cessation.
Quitt® 2mg chewing gum is intended for smokers
who were smoking up to a maximum of 20 cigarettes
per day before treatment. Quitt® 4mg chewing gum
is intended for heavily addicted smokers (who were
smoking more than 20 cigarettes per day before
treatment). The rate of success can be increased by
additional advice and supportive measures. Quitt®
2mg/4mg chewing gum is also suitable for diabetics.
Recommended dose for cessation
1 piece of Quitt® 2mg/4mg chewing gum every hour,
maximum 16 pieces per day. 8-12 pieces per day
are regarded as standard. After 4-6 weeks the dose
should be gradually reduced by increasing the interval length between each dose or switching from
Quitt® 4mg to Quitt® 2mg.
The first attempt at discontinuing use of Quitt®
2mg/4mg chewing gum should be made when the
average daily use in the previous week has been 1-2
pieces. The chewing gum should, however, always
be within reach for a certain period of time after
discontinuing treatment in order to counteract any
craving recurrences. Treatment with Quitt® 2mg/4mg
chewing gum for more than 6 months is generally
not recommended.
Recommended dose for substitution
A piece of Quitt® 2mg/4mg chewing gum can be
chewed whenever the desire to smoke occurs. The
number of pieces per day is generally 8-12 and must
not under any circumstance exceed 30/15 pieces of
gum daily.
It is particularly important to chew Quitt® 2mg/4mg
chewing gum slowly. In this way the nicotine is absorbed mainly through the oral mucosa into the
body. This results in a nicotine concentration in the
blood which switches off the craving for nicotine for
a prolonged period. Chewing the gum rapidly and/or
intensively should be avoided, so that the nicotine is
not released too rapidly from the chewing gum base,
making it unavailable for absorption.
Packaging details
Available pack counts: 12, 20, 24, 30, 36, 48, 50, 80,
96 and 108. The chewing gum is packed in 10 or
12 count blisters. The blister pack is made of PVC/
PVdC thermoformed blister cards, sealed with aluminum foil. Availability of pack sizes is subject to local regulations.
Other product information
Shelf life: 24 months
Storage conditions: Keep below 25°C
If the smoker subsequently wishes to stop smoking
completely, the smoker should stop smoking as he/
she feels able, and no later than 6 months after initiation of treatment. However, if unsuccessful after 9
months upon initiation of treatment, the doctor must
be consulted.
Method of administration
1 piece of Quitt® 2mg/4mg chewing gum is chewed
for approximately 30 minutes with breaks, in order
to release all the available nicotine from the chewing
gum base.
Fertin Pharma A/S
Dandyvej 19
DK-7100 Vejle
www.fertin.com
[email protected]
Phone: +45 7215 1300