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FDA Approves First Nicotine-Free Prescription Drug to Help Quit
Smoking

RESEARCH TRIANGLE PARK, N.C., May 15, 1997 -- At a time of heightened
attention on tobacco and the addictive nature of nicotine, the U.S.
Food and Drug Administration (FDA) has cleared for use the first
nicotine-free prescription medicine to help people quit smoking.
Zyban(TM) (bupropion hydrochloride) Sustained-Release Tablets offer
smokers an entirely new approach to quitting smoking.

Zyban, developed by Glaxo Wellcome Inc., is indicated as an aid to
smoking cessation treatment and will be available by prescription in
six to eight weeks. The medicine will include a personalized patient
support program called the Zyban Advantage Plan(TM). The support
program will be available at no additional cost to the patient.

Zyban is distinctly different from existing therapies to treat
nicotine addiction in that it is a nicotine-free tablet. The current
alternative involves replacing cigarettes with either a nicotine patch
or nicotine gum.

In addition, patients start Zyban before they quit smoking. They are
advised to set a date to stop smoking during the second week of
therapy to allow Zyban to reach adequate blood levels. Nicotine
replacement products require users to quit smoking completely on the
day therapy begins.

Experts in smoking cessation say that smoking is a biochemical
addiction, not just a bad habit. While it is not clear how Zyban
works, it does effect noradrenergic and/or dopaminergic mechanisms in
the brain which have been implicated as pathways of nicotine
addiction.

"Zyban is an innovative new treatment because it is the first
nicotine- free prescription medicine to treat tobacco dependence by
affecting the biology of addiction," says Michael C. Fiore, MD,
director of the Center of Tobacco Research and Intervention at the
University of Wisconsin Medical School. "Combining this medication
with social support and some simple skills to quit smoking gives
individuals new hope in overcoming tobacco addiction."

Dr. Fiore noted, however, that success is highly dependent on the
smoker's level of commitment and ability to manage triggers associated
with smoking.

It is for this reason that the Zyban Advantage Plan was developed. The
Zyban Advantage Plan is offered at no cost to patients taking Zyban
and provides additional support and specific smoking cessation
techniques. The makers of Zyban recommend that the drug therapy and
the Zyban Advantage Plan be used as part of a comprehensive smoking
cessation treatment program as recommended by a healthcare
professional.

Efficacy of Zyban

The effectiveness of Zyban as an aid to smoking cessation was
demonstrated in two placebo-controlled, double-blind studies involving
over 1,500 chronic smokers who smoked at least 15 cigarettes a day. In
one study, Zyban was compared to placebo; in the other study, Zyban
was evaluated versus placebo, a nicotine patch (Ciba-Geigy Corporation’s
Habitrol(R)), and the if Zyban with the nicotine patch. In both
studies, all patients received brief individual smoking cessation
counseling.

In the study involving the patch, patients treated with Zyban had
significantly higher four-week quit rates than those treated with the
patch. Patients treated with the combination of Zyban and the patch
had significantly higher quit rates than those treated with the patch
alone. Quit rates with combination therapy, while higher, were not
statistically higher than quit rates with Zyban alone. The four-week
quit rates from this study were 23% for placebo; 36% for the patch;
49% for Zyban; and 58% for the combination of Zyban and the patch.

Results from the two studies demonstrated that patients treated with
Zyban 300 mg/day had more than a two-fold chance of quitting than
patients treated with placebo. Quit rates in clinical trials are
affected by the population selected and may be lower for the general
population.

For many patients, treatment with Zyban reduced withdrawal symptoms.
Withdrawal symptoms showing the most pronounced reductions were:
irritability, frustration or anger, anxiety, difficulty concentrating,
restlessness, and depressed mood or negative affect. In patients
treated with Zyban, there also was evidence of a reduction in craving
for cigarettes or urge to smoke.

The most common side effects associated with the use of Zyban are dry
mouth and insomnia. These side effects are generally mild and often
disappear after a few weeks.

The use of Zyban also is associated with a dose-dependent risk of
seizure. Therefore, higher than recommended doses should not be
prescribed and Zyban should not be used in people who are already
taking Wellbutrin(R), Wellbutrin(R) SR, or any other medications that
contain bupropion.

Zyban also should not be used in patients with a seizure disorder who
have a history or are currently diagnosed with bulimia or anorexia
nervosa. It also should not be used in people who are taking or have
recently taken a monoamine oxidase inhibitor (MAOI). It is important
that patients tell their healthcare professional about all medicines
-- prescription or over-the-counter -- they are taking or plan to
take.

Glaxo Wellcome Inc., a subsidiary of London-based Glaxo Wellcome plc.,
is a leading research-based pharmaceutical company located in Research
Triangle Park, NC.



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