FDA Approves Paxil CR™ For The Treatment Of Social Anxiety Disorder
In October 2003, the US Food and Drug Administration (FDA) approved Paxil CR™
(paroxetine HCl) Controlled-Release Tablets for the treatment of social anxiety
disorder. Paxil CR is the first and only controlled-release SSRI (selective
serotonin reuptake inhibitor) approved for social anxiety disorder, a potentially
debilitating condition that affects more than 10 million Americans. In clinical
trials, Paxil CR was generally well tolerated, with a low patient drop
out rate due to adverse events compared to placebo (3% vs. 2% respectively). Paxil
CR is also indicated for the treatment of depression, panic disorder and
premenstrual dysphoric disorder (PMDD).
"Adverse events and poor compliance are often stumbling blocks
in treating disorders like social anxiety disorder. As a result, many patients
continue to suffer the debilitating symptoms of their condition, which often
severely limits their social, home and work relationships," said Dr. Murray
Stein, Professor of Psychiatry, University of California San Diego. "The low
rate of drop outs due to adverse events seen with the Paxil CR social anxiety
disorder study may offer new hope to patients."
The tolerability and efficacy of Paxil CR™
(paroxetine HCl) Controlled-Release Tablets in the treatment of social anxiety
disorder were established in a 12-week, multi-center, placebo-controlled study
of 370 patients. Patients were randomized to receive either a flexible
dose regimen of Paxil CR (12.5 mg - 37.5 mg per day) or placebo. Patients
given Paxil CR showed statistically significant and clinically meaningful
differences versus placebo in the two primary efficacy variables: mean change
from baseline in the Liebowitz Social Anxiety Scale (LSAS) and percent of responders
defined by a CGI-Global Improvement score of one (very much improved) or two
Social anxiety disorder, also known as social phobia, is the
most common type of anxiety disorder. It affects more Americans than general
anxiety disorder, which is the second most common type of anxiety disorder.
People with social anxiety disorder have an intense fear of being scrutinized
by other people in social or performance situations. When exposed
to "everyday" social situations such as meetings, classes, parties, speaking
in public and talking to strangers or authority figures, people with social
anxiety disorder may literally become "sick with fear" and often develop symptoms
including rapid heartbeat, sweating, shaking and upset stomach. Some people
with social anxiety disorder avoid these situations altogether, severely limiting
their life, work and social relationships.
Social anxiety disorder is considered one of the most under-diagnosed anxiety
disorders with only a small percentage of patients receiving treatment. Often
people recognize that they have a life-impairing condition, but do not realize
they suffer from an actual medical disorder that can be treated. Ricky Williams,
star running back for the Miami Dolphins, was one of those people. After being
diagnosed with social anxiety disorder and getting treatment and therapy, Williams
has now taken his struggle to the public hoping to motivate other sufferers,
who may be scared or embarrassed, to seek help. Too often, sufferers of this
condition are not even aware that it is a medical condition or that medical
treatment is available to them.
For more information on social anxiety disorder, click here.
Created: 12/5/2003  - Donnica Moore, M.D.