MADISON, N.J., Dec. 23 /PRNewswire-FirstCall/ -- Each year, two percent to
four percent of Americans experience the debilitating emotional and physical
symptoms of generalized anxiety disorder (GAD). Given the chronic nature of
this condition, it is critical that patients with GAD are treated with an
effective long-term therapy. The goal of therapy should be to virtually
eliminate their symptoms and prevent relapse. EFFEXOR(R) XR (venlafaxine HCl),
a serotonin-norepinephrine reuptake inhibitor (SNRI) and the first
antidepressant approved for the treatment of GAD, remains the only
antidepressant indicated for the short- and long-term treatment of patients
with this disorder.
"The excessive uncontrollable worry associated with generalized anxiety
disorder can greatly disrupt an individual's daily life, which is why it is
critical to virtually eliminate the symptoms of this chronic, debilitating
condition," says Norman Sussman, M. D., professor of psychiatry, New York
University School of Medicine. "EFFEXOR XR is effective in helping patients
with GAD achieve and sustain virtual elimination of symptoms, while also
reducing the likelihood they will suffer from a relapse."
According to three pooled analyses of 1,841 GAD patients in five
double-blinded studies, EFFEXOR XR was effective in treating GAD patients'
emotional and physical symptoms and was equally effective regardless of the
initial severity of physical symptoms. Moreover, 767 GAD patients treated
with EFFEXOR XR, and followed up for six months, demonstrated continued
improvement across the spectrum of symptoms beyond their first eight weeks of
therapy.
"EFFEXOR XR has a proven efficacy and safety profile through a wealth of
published data and its use in over 8.4 million patients with GAD, depression,
and social anxiety disorder (SAD) since its approval in 1997," said Victoria
Kusiak, M.D., Vice President of Global Medical Affairs and North American
Medical Director, Wyeth Pharmaceuticals. "Because GAD often coexists with
depression, patients who have both conditions should work with their physician
to find a medication, such as EFFEXOR XR, that's proven to be effective in
improving and virtually eliminating the symptoms of both GAD and depression."
SNRIs, such as EFFEXOR XR, affect the level of two chemicals in the brain,
serotonin and norepinephrine, thought to play a key role in depression, GAD,
and SAD. Correcting the imbalance of these two chemicals may help relieve the
symptoms of these conditions.
Supporting Studies
For GAD patients with mostly emotional symptoms, EFFEXOR XR delivered
significantly greater rates of remission (defined as a Hamilton Rating Scale
for Anxiety [HAM-A] total score =7) versus placebo for emotional symptoms
(p<0.001) and physical symptoms (p<0.05) after eight weeks of treatment, as
well as for both types of symptoms after 24 weeks of treatment (p<0.001), as
measured using the HAM-A, according to a pooled analysis of 1,841 patients in
five double-blind studies. Furthermore, for GAD patients with mostly physical
symptoms, EFFEXOR XR delivered significantly greater rates of remission versus
placebo of emotional symptoms (p<0.05) and physical symptoms (p<0.001) at week
eight, as well as for both emotional and physical symptoms at week 24
(p<0.05).
GAD is one of the most common anxiety disorders, thought to be due to a
chemical imbalance in the brain marked by a constant and exaggerated sense of
worry that has lasted for at least six months. GAD often coexists with
depression, a condition that affects approximately 19 million Americans
annually. With the right treatment, it is possible for people with GAD and/or
depression to improve or virtually eliminate their symptoms, get back to being
themselves and re-engage in their favorite activities.
About EFFEXOR XR
EFFEXOR XR is a structurally novel antidepressant chemically unrelated to
any other available antidepressant. The most common adverse events reported
in EFFEXOR(r) (venlafaxine HCl) short-term placebo-controlled depression
trials and EFFEXOR XR short-term placebo-controlled depression, generalized
anxiety disorder (GAD), and/or social anxiety disorder (SAD) trials (incidence
(10% and (2x that of placebo) were anorexia, asthenia, constipation,
dizziness, dry mouth, ejaculation problems, impotence, insomnia, nausea,
nervousness, somnolence, and sweating.
EFFEXOR/EFFEXOR 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. Abrupt discontinuation or dose reduction has been associated
with discontinuation symptoms. Patients should be counseled on possible
discontinuation symptoms and monitored while discontinuing the drug; the dose
should be tapered gradually; see the Dosage and Administration section of the
Prescribing Information.
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.
About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), has leading
products in the areas of women's health care, cardiovascular disease, central
nervous system, inflammation, hemophilia, oncology, and vaccines. Wyeth is
one of the world's largest research-driven pharmaceutical and health care
products companies. It is a leader in the discovery, development,
manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology
products, and nonprescription medicines that improve the quality of life for
people worldwide. The Company's major divisions include Wyeth
Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
EFFEXOR(R) and EFFEXOR(R) XR are registered trademarks of Wyeth
Pharmaceuticals Inc.
SOURCE Wyeth Pharmaceuticals
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Related links:
http://www.wyeth.com
CONTACT:
Douglas Petkus, +1-484-865-5140, or Jenifer
Antonacci, +1-484-865-5220, or Investors - Justin Victoria,
+1-973-660-5340, all for Wyeth Pharmaceuticals
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