| Effexor (R) Xr Approved for the Treatment of Social Anxiety Disorder | |
The FDA approved EFFEXOR XR as treatment for SAD based on studies that
demonstrate the drug's significant effectiveness as a short-term treatment for
patients with SAD.
"Social anxiety disorder is a debilitating illness that can greatly disrupt an
individual's daily life, yet the disorder is widely undertreated," says Michael
R. Liebowitz, M.D., professor of clinical psychiatry at Columbia University,
director of the Anxiety Disorders Clinic at the New York State Psychiatric
Institute, and lead investigator of one of the two pivotal EFFEXOR(r) XR SAD
studies. "Now that EFFEXOR XR is available for SAD, we have a different kind of
treatment option to help alleviate the disabling symptoms of this illness."
Social anxiety disorder (SAD), also known as social phobia, is the third most
common psychiatric disorder in the United States. SAD is a mood disorder marked
by overwhelming and disabling fear of scrutiny, embarrassment, or humiliation in
social situations, which are often avoided or else endured with dread. In
particular, SAD patients have a 40 to 50 percent lifetime prevalence of
coexisting major depressive disorder.
"There are already abundant data supporting significant efficacy of EFFEXOR XR
in treating patients with depression and/or general anxiety disorder," said
Victoria Kusiak, M.D., Vice President of Global Medical Affairs and North
American Medical Director of Wyeth Pharmaceuticals. "Now with the approval of
the social anxiety disorder indication, its efficacy has been demonstrated
across an even broader range of symptoms."
Supporting Studies
In two 12-week studies, EFFEXOR XR significantly reduced patients' SAD symptoms
compared to placebo as early as four or six weeks, with continued improvements
through week 12. Scores were measured using the Liebowitz Social Anxiety Scale (LSAS).
In the first study, treated patients had significant reductions in average LSAS
scores at week six (P <0.05), and even greater reductions occurred by week 12 (P
<0.001).
In the second study, the significant reduction in average LSAS scores with
EFFEXOR(r) XR occurred at the fourth week (P <0.01), and by week 12, the treated
patients averaged even greater reductions compared to the placebo group (P
<0.001).
None of the investigators or patients in either study (279 patients in the first
and 272 patients in the second) knew whether the patients received EFFEXOR XR or
a placebo until the trials ended. The once-daily doses of EFFEXOR XR ranged from
75 to 225 milligrams. Prior to the clinical trials, all participants received
placebo for three to 10 days and after the trials, investigators tapered the
patients' dosages for 14 days.
Treatment-related adverse events reported by patients included nausea, insomnia,
anorexia, dry mouth, and sweating.
About EFFEXOR XR
EFFEXOR XR is a structurally novel antidepressant chemically unrelated to any
other available antidepressant. EFFEXOR XR is believed to increase levels of
both serotonin and norepinephrine, two of the brain chemicals thought to be
implicated in depression and anxiety disorders. Serotonin and norepinephrine are
thought to regulate mood and may affect motivation and sense of well-being.
EFFEXOR XR was discovered and developed by Wyeth Pharmaceuticals, the
pharmaceutical division of Wyeth. The product is also marketed by Wyeth
Pharmaceuticals. The immediate-release formulation was approved by the FDA in
1993; the extended-release (XR) formulation was approved in 1997. These
medications are available only by prescription.
The most common adverse events reported in EFFEXOR XR short-term
placebo-controlled depression trials (incidence greater than or equal to 10% and
greater than or equal to twice that of placebo) were nausea, dizziness,
somnolence, delayed ejaculation, sweating, dry mouth, and nervousness; and in
short-term generalized anxiety disorder (GAD) trials were nausea, dry mouth,
abnormal ejaculation, constipation, and sweating.
EFFEXOR(r) XR is contraindicated in patients taking monoamine oxidase inhibitors
(MAOIs). Treatment with venlafaxine is associated with sustained increases in
blood pressure (BP) in some patients. Regular BP monitoring is recommended.
Patients should not be abruptly discontinued from antidepressant medication,
including EFFEXOR XR; see the Dosage and Administration section of the
Prescribing Information.
---Wyeth Pharmaceuticals
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