Question:
First Medication for the Treatment of Social Anxiety Disorder Approved by the FDA?
Answer:
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.
I'm a perfect example of someone with social phobia. I tried Paxil and
it did nothing for me. It probably helps alot of people though. A large portion of my obsessions are about "what is everyone thinking
of me?" and "everyone hates me", etc.
Right now, because I haven't seen many responses to my posts lately,
I'm near convinced that I'm on the kill-list on everyone's
newsreaders.
I don't know if that's true, I'm going nuts trying to reassure myself,
but the doubting is getting in the way. OCD portion of my social
phobia.
I read everything you write kbeth. Sometimes I don't have anything useful to
contribute so I don't respond. You are not on my killfile, kbeth.
I don't usually suffer from social phobia so I was just keeping my mouth
shut because I didn't have any experience or advice to offer to you about
it.
