|
|
| Zoloft(R) Receives FDA Approval for Treatment of Social Anxiety Disorder |
First Selective Serotonin Reuptake Inhibitor Approved for Long-Term Treatment
of Social Anxiety Disorder
NEW YORK, Feb. 10 /PRNewswire/ -- Pfizer Inc said today it has received
approval from the U.S. Food and Drug Administration (FDA) for Zoloft(R)
(sertraline hydrochloride) for acute and long-term treatment of social anxiety
disorder.
Zoloft is the first and only selective serotonin reuptake inhibitor (SSRI)
approved in the United States for long-term treatment in patients with this
condition.
Two double-blind, placebo-controlled trials including more than
600 patients demonstrated that Zoloft was significantly more effective than
placebo in reducing the anxiety, fear and avoidance behaviors experienced by
people with social anxiety disorder, also known as social phobia. In one of
these studies 53 percent of patients receiving Zoloft responded to treatment
compared to 29 percent of placebo patients. Patients enrolled in the study
had a mean duration of social anxiety disorder for nearly 21 years.
"Social anxiety disorder is the most common anxiety disorder in the United
States. It affects work functioning, social relationships and also impairs
quality of life," said Cathryn Clary, MD, Senior Medical Director, Pfizer Inc.
"Zoloft's demonstrated efficacy in both acute and long-term treatment provides
an important new option for people suffering from this disorder."
Zoloft was shown to be effective for long-term treatment of social anxiety
disorder. In a continuation of a 20-week study, patients who responded to
Zoloft were re-randomized to treatment with Zoloft or placebo for 24 weeks.
Ninety-six percent of patients who responded to treatment with Zoloft
maintained an effective treatment response for 24 weeks as compared to
64 percent on placebo.
"These study results demonstrate that Zoloft is an effective first-line
therapy for social anxiety disorder," said Dr. Michael R. Liebowitz, Director
of The Anxiety Disorders Clinic at the New York State Psychiatric Institute
and Professor of Clinical Psychiatry at Columbia College of Physicians and
Surgeons. "Even patients with long-term illness and high levels of symptom
severity responded well to treatment with Zoloft."
Social anxiety disorder is an impairing and often chronic disorder. It is
characterized by an intense, persistent fear of social or performance
situations that may result in scrutiny by others. The individual fears that
he or she will act in a way (or show anxiety symptoms) that will be
humiliating or embarrassing.
Individuals with social anxiety disorder also experience a range of
physical symptoms including sweating, blushing, tremors or heart palpitations
when exposed to social or performance situations. Adults with the disorder
recognize that their fear is excessive or unreasonable.
Patients with social anxiety disorder may have few friendships, experience
trouble dating, be less likely to marry, drop out of school prematurely,
reject promotions at work, suffer from low self-esteem and feelings of
inferiority, as well as have difficulty being assertive.
Zoloft is also indicated for depression, posttraumatic stress disorder
(PTSD), panic disorder (with or without agoraphobia), adult and pediatric
obsessive-compulsive disorder (OCD) and premenstrual dysphoric disorder
(PMDD). Zoloft is approved for the long-term treatment of PTSD, OCD and panic
disorder in adults.
Zoloft is the most prescribed brand of its kind in the United States and
is available in 96 countries around the world. Since its approval more than a
decade ago, millions of people have been treated with Zoloft.
Patients who are taking monoamine oxidase inhibitors (MAOI) or pimozide
should not take Zoloft.
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.
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 Zoloft prescribing information is available upon request, or at
http://www.zoloft.com.
SOURCE Pfizer Inc
back to topRelated links:
Company News On-Call: Pfizer's press releases are
available through PR Newswire's Company News On-Call service on
PRN's Web Site. Visit
Company News On-Call:
CONTACT:
Geoff Cook for Pfizer, +1-212-733-5244
Logo: A free corporate logo to accompany this story is available
immediately via Wieck Photo Database to any media with telephoto
receiver or electronic darkroom, PC or Macintosh, that can accept
overhead transmissions. To retrieve a logo, please call
972-392-0888
