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Zoloft(R) Is the First and Only Treatment Approved for Long-Term Use in Posttraumatic Stress Disorder (PTSD)

              FDA Approval Based on Study Showing Significantly
                     Lower Relapse Rates in Men and Women

    NEW YORK, Aug. 16 /PRNewswire/ -- Pfizer Inc (NYSE: PFE) today announced
that it has received U.S. Food and Drug Administration (FDA) approval for
long-term use of Zoloft(R) (sertraline HCl) in the treatment of posttraumatic
stress disorder (PTSD).
    The new label for Zoloft indicates it is safe and effective in preventing
relapse of PTSD and in sustaining symptom improvement over 28 weeks in both
men and women.
    The FDA granted the label change following review of the first-ever
placebo-controlled study to examine the efficacy and tolerability of long-term
pharmacotherapy of PTSD.  Zoloft is currently the only medication approved for
PTSD and is the most prescribed brand in the U.S. for the treatment of mood
and anxiety disorders.
    "This new study shows that patients can be maintained on Zoloft over the
long term which is very significant given the high rate of relapse in PTSD
patients and the fact that the average duration of the illness is at least
several years," said Cathryn M. Clary, M.D., senior medical director, Pfizer.
"Prior studies with Zoloft demonstrated the safety and efficacy of the product
in the acute and continuation phases of treatment."
    Posttraumatic stress disorder is a common psychiatric disorder, with
prevalence rates higher than diabetes and asthma.  In the U.S., one out of
13 individuals will experience PTSD at some point in their lives following
exposure to an extreme traumatic event.  The most common traumas associated
with a risk for PTSD include experiencing sexual or physical assault, a
serious accident or injury, and the sudden, unexpected death of a close friend
or relative.  Women are twice as likely as men to suffer from PTSD.
    Zoloft's label change was based on a long-term study that involved PTSD
patients who had previously responded during a 24-week open trial of Zoloft.
The efficacy of Zoloft in maintaining a response in patients with PTSD was
demonstrated for up to 28 weeks following this 24-week period.  The study also
demonstrated that both men and women maintained their treatment gains across
the three core symptom clusters of PTSD: reexperiencing/intrusion,
avoidance/numbing and arousal.  The new label recommends that patients should
be periodically reassessed to determine the need for maintenance treatment.
    Zoloft should not be taken together with monoamine oxidase inhibitors
(MAOI), which are medicines used to treat depression and other conditions.
    Some people taking Zoloft may have side effects.  The most common side
effects of Zoloft include upset stomach, having trouble sleeping, diarrhea,
dry mouth, sexual side effects, feeling unusually sleepy or tired, tremor,
indigestion, increase of sweating, feeling agitated, and decreased appetite.
In clinical studies with Zoloft, few patients were bothered enough by side
effects to stop taking their medicine. As PTSD is a more common disorder in
women than men, the majority of patients in the Zoloft clinical trials were
women.  Zoloft was effective in treating PTSD in the total population treated.
Response rates were similar for men and women, but only women showed a
significant difference versus placebo in the acute trials.  While the clinical
significance of this apparent gender interaction in the acute studies is
unknown, Zoloft was found to be effective for both men and women in the longer
term study in decreasing their risk for relapse.
    Zoloft is indicated for major depression, panic disorder,
obsessive-compulsive disorder (OCD) in both children and adults, and is the
first and only treatment indicated for posttraumatic stress disorder (PTSD).
(Zoloft received FDA approval for treatment of PTSD on December 8, 1999.)
Millions of people in 96 countries around the world have been treated
successfully with Zoloft for over a decade.
    Pfizer Inc discovers, develops, manufactures and markets leading
prescription medicines, for humans and animals, and many of the world's
best-known consumer products.

    Full prescribing information is available upon request.



SOURCE Pfizer Inc




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