CHANTIX® (varenicline) Demonstrates Efficacy in Smokers Who Previously Attempted to Quit Smoking with CHANTIX

  CHANTIX® (varenicline) Demonstrates Efficacy in Smokers Who Previously
  Attempted to Quit Smoking with CHANTIX

    New Positive Top-line Results in Adult Smokers Re-treated With CHANTIX

Business Wire

NEW YORK -- January 24, 2013

Pfizer Inc. (NYSE: PFE) announced today that a post-marketing study assessing
the efficacy and safety of varenicline (CHANTIX^®/CHAMPIX^®) in a population
of smokers who had made a previous attempt to quit smoking with CHANTIX, and
either did not succeed in quitting or relapsed after treatment, met its
primary endpoint.

CHANTIX significantly increased continuous abstinence rates compared to
placebo at weeks nine to 12, the last four weeks of treatment (primary
endpoint). The efficacy rates were consistent with findings seen in other
CHANTIX clinical trials in smokers who had not been previously treated with
CHANTIX. The safety and tolerability profile of CHANTIX in this study was also
consistent with previous studies. The most commonly reported
treatment-emergent adverse events were nausea, abnormal dreams and headache,
with incidence rates similar to previous CHANTIX studies.

“Smoking is considered a chronic, relapsing medical condition. The
availability of pharmacological treatments has led to a large and growing
population of smokers who have made previous quit attempts but were ultimately
unsuccessful,” said Steven J. Romano, M.D., senior vice president and
medicines development group head, Primary Care Business Unit, Pfizer Inc.
“These new data show that, for some adult smokers who had previously taken
CHANTIX but either did not quit smoking or relapsed after quitting, another
quit attempt with CHANTIX may be fruitful.”

Study Background

This study was a Phase 4, 12-week, randomized, double-blind,
placebo-controlled, multi-center study, which evaluated the efficacy and
safety of varenicline tartrate 1 mg BID for smoking cessation in adult
subjects, who had made a previous attempt to quit smoking with CHANTIX and
either did not succeed in quitting or relapsed after treatment. Patients
included in this study had taken CHANTIX for a smoking-cessation attempt in
the past (for a total treatment duration of a minimum of two weeks), and at
least three months prior to study entry, and had been smoking for at least
four weeks.

About CHANTIX

CHANTIX was approved by the FDA in May 2006 as an aid to smoking cessation
treatment in adults 18 and older. CHANTIX has been shown to increase the
likelihood of abstinence from smoking for as long as one year compared to
treatment with placebo. Adults who smoke may benefit from quit smoking support
programs and/or counseling during their quit attempt. It’s possible that
patients might slip up and smoke while taking CHANTIX. If patients slip up,
they can stay on CHANTIX and keep trying to quit.

Important CHANTIX (varenicline) Safety Information

Some people have had changes in behavior, hostility, agitation, depressed
mood, suicidal thoughts or actions while using CHANTIX to help them quit
smoking. Some people had these symptoms when they began taking CHANTIX, and
others developed them after several weeks of treatment or after stopping
CHANTIX. If the CHANTIX patient, their family or caregiver notice any of these
symptoms or behaviors, they should stop taking CHANTIX and call their doctor
right away. They should tell their doctor about any history of depression or
other mental health problems, which could get worse while taking CHANTIX.

Patients should not take CHANTIX if they’ve had a serious allergic or skin
reaction to it. If they develop serious allergic or skin reactions, including
swelling of the face, mouth, throat, or a rash, they should stop taking
CHANTIX and see their doctor right away as some of these can be
life-threatening.

Patients should tell their doctor if they have a history of heart or blood
vessel problems or have any new or worse symptoms during treatment with
CHANTIX. Patients should get emergency medical help right away if they have
any symptoms of a heart attack or stroke.

Dosing may be different for patients who have kidney problems. Until the
patient knows how CHANTIX affects them, they should use caution when driving
or operation machinery. Common side effects include nausea, trouble sleeping
and unusual dreams. CHANTIX should not be taken with other quit-smoking
products. Patients should tell their doctor which medicines they are taking as
these medicines may work differently when quitting smoking.

Full prescribing information and Medication Guide are available at
www.pfizer.com.

Pfizer Inc.: Working together for a healthier world™

At Pfizer, we apply science and our global resources to improve health and
well-being at every stage of life. We strive to set the standard for quality,
safety and value in the discovery, development and manufacturing of medicines
for people and animals. Our diversified global health care portfolio includes
human and animal biologic and small molecule medicines and vaccines; as well
as many of the world’s best-known consumer products. Every day, Pfizer
colleagues work across developed and emerging markets to advance wellness,
prevention, treatments and cures that challenge the most feared diseases of
our time. Consistent with our responsibility as the world’s leading
biopharmaceutical company, we also collaborate with health care providers,
governments and local communities to support and expand access to reliable,
affordable health care around the world. Formore than 150 years,Pfizer has
worked to makea difference for all who rely on us.

Varenicline is known as CHANTIX^® in the U.S. and CHAMPIX^® outside the U.S.

Contact:

Pfizer Inc.
Media Contact:
Jennifer Kokell, 212-733-2596
Jennifer.Kokell@pfizer.com
or
Investor Contact:
Suzanne Harnett, 212-733-8009
Suzanne.Harnett@pfizer.com
 
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