PHILADELPHIA:
(PRNewswire) SmithKline Beecham (NYSE: SBH) today announced that
the U.S. Food and Drug Administration (FDA) approved Paxil(R)
(paroxetine HCl) for the treatment of social anxiety disorder,
making it the first and only medication approved for this disorder
in the United States.
Affecting over 10 million Americans, social anxiety disorder,
also known as social phobia, is the most common type of anxiety
disorder and the third most common psychiatric disorder after
depression and alcoholism. Social anxiety disorder is also considered
one of the most neglected anxiety disorders, with only five percent
of patients receiving some form of treatment.
People
with social anxiety disorder have an intense fear of being scrutinized
by other people in social or performance situations and of negative
evaluation. They literally become "sick with fear" and are afraid
of acting in a way that will be embarrassing or humiliating, causing
them to avoid such situations in the future or endure these "everyday"
situations with dread. These situations may include speaking in
public, initiating or maintaining a conversation with strangers
or people in authority, participating in meetings or classes,
attending parties or dating.
"The
FDA approval of Paxil for the treatment of social anxiety disorder
provides a much-needed addition to the physician's armamentarium
against mental illness," said Rodrigo Munoz, M.D., president of
the American Psychiatric Association and clinical professor of
psychiatry, University of California at San Diego. "The FDA's
action has given psychiatrists and other physicians an approved
option from which to develop effective treatment plans for this
debilitating disorder -- usually combining medication and some
form of psychotherapy." Paxil Effective in Treating Social Anxiety
Disorder Paxil was significantly more effective than placebo in
treating social anxiety disorder, based on results from three
12-week multicenter, placebo- controlled trials of adults. In
all studies, Paxil significantly reduced social anxiety, increased
participation in social activities, and improved the overall clinical
condition of patients with social anxiety disorder as measured
by the Clinical Global Impression (CGI) score (a commonly used
measure of disease burden) and the Liebowitz Social Anxiety Scale
(LSAS). In one study, 69 percent of patients treated with Paxil
(20 to 50 mg daily) responded to treatment (compared to only 29
percent of patients given placebo) at week 12. All three studies
confirmed that Paxil is safe and well- tolerated.
"Many
patients treated with Paxil had a very clinically meaningful response
to the medication -- experiencing reduction in their anxiety and
disability and improvement in their overall functioning," said
Murray Stein, M.D., professor of psychiatry at the University
of California at San Diego and lead investigator of two pivotal
trials.
In
social anxiety disorder patients, the most commonly observed adverse
events associated with the use of Paxil (incidence of 5 percent
or greater and incidence for Paxil at least twice that for placebo)
were sweating, nausea, dry mouth, constipation, decreased appetite,
somnolence, tremor, libido decreased, yawn, abnormal ejaculation,
female genital disorders and impotence.
Concomitant
use of Paxil in patients taking monoamine oxidase inhibitors (MAOIs)
is contraindicated. Comorbidity and Social Anxiety Disorder Many
people with social anxiety disorder also suffer from other mood
and anxiety disorders such as depression, panic disorder and obsessive
compulsive disorder. In one study of social anxiety disorder patients
who developed comorbid alcoholism, panic disorder or depression,
social anxiety disorder preceded the onset of alcoholism, panic
disorder and depression in 75 percent, 61 percent and 90 percent
of patients, respectively.
"Since
Paxil is approved to treat a variety of mood and anxiety disorders
such as depression and panic disorder, this medication may help
physicians stem the downward spiral of symptoms and conditions
that so often occur in connection with social anxiety disorder,"
said Jack Gorman, M.D., professor of psychiatry at the College
of Physicians and Surgeons at Columbia University. Not Just Shyness
Social anxiety disorder is not just shyness. Shyness may involve
uncomfortable feelings in social situations, but social anxiety
disorder is a clinical diagnosis that is much more pervasive,
distressing and interferes with normal functioning.
For
example, "normal" anxiety reaches a peak during the initial minutes
of interaction with an authority figure and generally diminishes
shortly thereafter, allowing people to successfully accomplish
their goal. However, the sustained level of intense anxiety experienced
by people with social anxiety disorder can severely impair their
ability to interact with their boss and may prevent them from
getting a promotion or assuming new responsibility because they
avoid the interaction altogether.
"I've
seen people treated for social anxiety disorder be able for the
first time to comfortably negotiate business meetings or attend
social events, where previously their anxiety overwhelmed them,"
said Dr. Gorman. "It is our hope that patients will now know that
they are not alone, that their disease has a name, and it is treatable
if they talk to their doctor."
Paxil
is a selective serotonin reuptake inhibitor (SSRI) that has been
used to treat a range of mood and anxiety disorders in more than
60 million patients worldwide. Of all the SSRIs, Paxil has the
most FDA-approved indications, namely depression, panic disorder,
obsessive compulsive disorder and now social anxiety disorder.
SmithKline
Beecham (NYSE: SBH) -- one of the world's leading healthcare companies
-- discovers, develops, manufactures, and markets pharmaceuticals,
vaccines, over-the-counter medicines, and health-related consumer
products, and provides healthcare services including clinical
laboratory testing and disease management. For company information,
visit SmithKline Beecham on the World Wide Web at http://www.sb.com.
For more information about Paxil, visit http://www.paxil.com.
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