Health, Inc., announced today that the U.S. Food and Drug Administration
(FDA) has given approval of Thrive(TM) (Nicotine Polacrilex Gum USP) 2mg
and Thrive(TM) (Nicotine Polacrilex Gum USP) 4mg to help smokers quit
smoking in 12 weeks. The unexpectedly bold, mint-flavored nicotine
replacement gum will be available as an over-the-counter (OTC) product
nationwide beginning in late 2007 to help smokers double their chances of
kicking the habit.
“The health benefits of living smoke-free are substantial and nearly
immediate,” said Ray Niaura, Ph.D., professor of psychiatry, Brown Medical
School. “However, quitting smoking is not easy. People who combine the
correct combination of counseling, pharmacotherapy such as Thrive gum, and
support from friends and family are more likely to succeed.”
According to the Centers for Disease Control (CDC), more than 44
million Americans over the age of 18, or one in five adults, are smokers.
Additionally, 33 million, or 70 percent, of them report they are interested
in completely quitting but are not yet smoke-free. The American Legacy
Foundation, a non-profit organization committed to smoking cessation and
prevention, encourages those trying to quit to use a combination of
Nicotine Replacement Therapy (NRT), such as Thrive gum, counseling
(professional, online or telephonic) and social support from friends and
family as part of a comprehensive quit plan.
When used as directed, Thrive gum delivers low, controlled levels of
nicotine to the bloodstream to help reduce cravings and other withdrawal
symptoms associated with the cessation of smoking. Thrive gum 2mg is
designed for those who smoke fewer than 25 cigarettes each day, and Thrive
gum 4mg is designed for those who smoke 25 or more cigarettes each day.
“Thrive will help smokers to conquer smoking in just 12 weeks, while
continuing to lead the fulfilling lifestyle they’ve always enjoyed,” said
Brian McNamara, Senior Vice President and General Manager, Novartis
Consumer Health OTC. “As a global health care leader with a tradition of
delivering innovative, self-medication treatments, Novartis applauds the
efforts of those who are taking steps toward leading a smoke-free life.”
According to the CDC, smoking-related diseases claim the lives of an
estimated 438,000 Americans each year, costing the U.S. more than $167
billion in health care and lost productivity expenses annually. The
approval of Thrive gum comes on the heels of the U.S. Surgeon General’s
report on the effects of second-hand smoke stating that smoke-free
environments are the only approach that protect non-smokers from the
dangers of secondhand smoke.
Through a 12-week program with the Thrive user’s guide and available
audio CD, those interested in quitting smoking can gradually reduce
nicotine levels in their body to help conquer their smoking habit in 12
weeks. Additionally, Thrive has established a toll-free counseling line to
aid smokers in their attempt to quit smoking.
Thrive gum is a medicine and must be used as directed to achieve the
best results. Chew the gum slowly until it tingles. Then park it between
your cheek and gum. When the tingle is gone, begin chewing again until the
tingle returns. Repeat this process until most of the tingle is gone (about
30 minutes). For best results do not eat or drink anything for 15 minutes
before or while chewing the gum.
Important Safety Information
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 Thrive gum if you continue to smoke, chew tobacco, use
snuff, or use a nicotine patch or other nicotine containing products.
Ask your doctor before use if you have a sodium restricted diet, heart
disease, a recent heart attack or irregular heartbeat, high blood pressure
not controlled with medication, stomach ulcer or diabetes.
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.
Stop use and ask a doctor if mouth, teeth or jaw problems occur, or if
irregular heartbeat or palpitation occur or if you get symptoms of nicotine
overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid
Keep Thrive out of reach of children and pets. Pieces of nicotine gum
may have enough nicotine to make children and pets sick. Wrap used pieces
of gum in paper and throw away in the trash. In case of overdose, get
medical help or contact a Poison Control Center right away.
Novartis currently markets Habitrol(R) in the U.S. and Nicotinell(R) in
Europe and adds Thrive to its nicotine replacement therapy portfolio.
This release contains certain “forward-looking statements”, relating to
the Novartis Group’s business, which can be identified by the use of
forward-looking terminology such as “will,” “more likely to,” “believed to
be,” or similar expressions, or by express or implied discussions regarding
potential future revenue from Thrive. Such forward-looking statements
involve known and unknown risks, uncertainties and other factors that may
cause actual results with Thrive to be materially different from any future
results, performance or achievements expressed or implied by such
statements. There can be no guarantee that Thrive will reach any particular
levels of revenue. Management’s expectations regarding Thrive could be
affected by, among other things, unexpected regulatory actions or delays or
government regulation generally; competition in general; government,
industry, and general public pricing pressures; uncertainties relating to
clinical trials, including new clinical data and additional analysis of
existing clinical data; the company’s ability to obtain or maintain patent
or other proprietary intellectual property protection; as well as other
risks and factors referred to in Novartis AG’s current Form 20-F on file
with the US Securities and Exchange Commission. Should one or more of these
risks or uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those anticipated,
believed, estimated or expected. Novartis is providing the information in
this press release as of this date and does not undertake any obligation to
update any forward-looking statements contained in this press release as a
result of new information, future events or otherwise.
Novartis AG (NYSE: NVS) is a world leader in offering medicines to
protect health, cure disease and improve well-being. Our goal is to
discover, develop and successfully market innovative products to treat
patients, ease suffering and enhance the quality of life. We are
strengthening our medicine-based portfolio, which is focused on strategic
growth platforms in innovation-driven pharmaceuticals, high-quality and
low-cost generics, human vaccines and leading self-medication OTC brands.
Novartis is the only company with leadership positions in these areas. In
2006, the Group’s businesses achieved net sales of USD 37.0 billion and net
income of USD 7.2 billion. Approximately USD 5.4 billion was invested in
R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ
approximately 100,000 associates and operate in over 140 countries around
the world. For more information, please visit novartis.
Novartis Consumer Health, Inc.