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Biopharmaceuticals

 News Release - May 23, 2006

New Study Reports Venlafaxine Extended Release May Help Adult Patients Prevent New Episodes of Depression for Up to Two Years

MADISON, N.J., May 23 (HSMN NewsFeed) -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE ), announced today new clinical trial data that showed venlafaxine extended release helped patients prevent new episodes of depression for up to two years. Results from the Prevention of Recurrent Episodes of Depression with VENlafaxine XR for Two Years (PREVENT) study were presented at the annual meeting of the American Psychiatric Association in Toronto, Canada.

The World Health Organization categorizes depression among the most disabling clinical diagnoses in the world and estimates that it affects nearly 340 million people worldwide, including approximately 19 million U.S. adults. Much of the burden of this disease is linked to its recurrent nature -- up to 85 percent of patients are likely to experience multiple episodes of depression.

"For the majority of people with depression, recurrence after remission occurs often," says Martin Keller, Professor and Chairman, Department of Psychiatry and Human Behavior, Brown University. "But these data showed that venlafaxine extended release can help prevent new episodes of depression -- providing an option to the millions of adult patients with depression who have experienced a disappointing setback or who are still seeking symptom relief."

The results of the two consecutive 12-month phases demonstrated that patients taking venlafaxine extended release were significantly more likely to remain recurrence-free than patients taking placebo. In the first maintenance phase, the probability of recurrence was 23.1 percent among patients given venlafaxine extended release (n=164) compared to 42.0 percent among patients given placebo (n=172) (P=0.005). The difference was even more pronounced in the second maintenance phase, with an 8.0 percent likelihood of recurrence among those given venlafaxine extended release (n=43) versus 44.8 percent among those given placebo (n=40) (P<0.001).

Patients in the study were 18 years or older and had a history of two or more episodes of major depression during the past five years, including their current episode. Additionally, these patients experienced at least three episodes of depression during their lifetime. Of this group, 80 percent had received antidepressant therapy during the course of their illness.

"Until about five years ago, antidepressant response was the standard for treatment; today, remission is the goal," says Philip Ninan, Vice President, Neuroscience, Wyeth Pharmaceuticals. "These data may encourage physicians to raise their expectations of treatment to include long-term prevention of new episodes of depression."

It is recommended that physicians who elect to use venlafaxine extended release for extended periods should re-evaluate the long-term usefulness of the drug for the individual patient.

About the Study

This multicenter, double-blind, placebo-controlled study followed outpatients with major depression through acute, continuation and two phases of maintenance therapy (12 months each) with venlafaxine extended release compared to fluoxetine and placebo. Due to study design, the fluoxetine group was included only as a reference during the maintenance phases.

During the acute treatment phase of this study, investigators randomly assigned 1,096 adult patients to receive treatment with venlafaxine extended release (75 to 300 mg/day) or fluoxetine (20 to 60 mg/day) for 10 weeks. Those who achieved a satisfactory therapeutic response were entered into a six-month continuation phase where they remained on the same drug. Those who responded during the continuation phase then entered into the maintenance phase, which consisted of two consecutive 12-month periods. At the start of each maintenance period, venlafaxine extended release responders were randomly assigned to receive treatment with venlafaxine extended release or placebo, while those who responded to fluoxetine continued to receive fluoxetine during each phase of the study. Recurrence was defined as a HAM-D17 total score greater than or equal to 12 and less than a 50-percent reduction from baseline HAM-D17 for two consecutive visits. The fluoxetine arm of the study was not re-randomized in maintenance years one and two; therefore, no comparison can be made between venlafaxine extended release and fluoxetine.

Adverse events reported in this study were comparable to placebo. During the second year of maintenance, discontinuation rates were 28 percent in the venlafaxine extended release group and 63 percent in the placebo group.

These data contribute to the extensive body of evidence of more than 12 years of clinical experience for venlafaxine extended release. As a neuroscience leader, Wyeth is committed to developing innovative solutions to address the unmet needs of patients living with mental illness. The Company's investment in long-term studies such as PREVENT is one important example of this commitment. Wyeth also has several investigational neuroscience compounds in development, addressing illnesses such as major depressive disorder, bipolar disorder, schizophrenia, Alzheimer's disease, and Neuropathic Pain.

VENLAFAXINE EXTENDED RELEASE IMPORTANT TREATMENT CONSIDERATIONS

Suicidality in Children and Adolescents

Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of venlafaxine extended release or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Venlafaxine extended release is not approved for use in pediatric patients.

* Venlafaxine extended release is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs).

* Adult and pediatric patients taking antidepressants can experience worsening of their depression and/or the emergence of suicidality. Patients should be observed closely for clinical worsening and suicidality, especially at the beginning of drug therapy, or at the time of increases or decreases in dose. Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and mania have been reported and may represent precursors to emerging suicidality. Stopping or modifying therapy should be considered especially when symptoms are severe, abrupt in onset, or not part of presenting symptoms.

* Treatment with venlafaxine is associated with sustained increases in blood pressure (BP) in some patients. Postmarketing cases of elevated BP requiring immediate treatment have been reported. Pre-existing hypertension should be controlled. Regular BP monitoring is recommended.

* Mydriasis has been reported in association with venlafaxine; therefore, patients with raised intraocular pressure or those at risk of acute narrow-angle glaucoma (angle-closure glaucoma) should be monitored.

* 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.

* The most common adverse events reported in venlafaxine extended release short-term placebo-controlled depression, generalized anxiety disorder (GAD), social anxiety disorder (SAD), and/or panic disorder (PD) trials (incidence >/= 10% and >/= 2x that of placebo) were anorexia, asthenia, constipation, dizziness, dry mouth, ejaculation problems, impotence, insomnia, nausea, nervousness, somnolence, and sweating.

Wyeth Pharmaceuticals

Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, cardiovascular disease, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products. 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.

The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include risks associated with the inherent uncertainty of the timing and success of product research, development and commercialization (including with respect to our pipeline products), drug pricing and payment for our products by government and third party-payors, manufacturing, data generated on the safety and efficacy of our products, economic conditions including interest and currency exchange rate fluctuations, changes in generally accepted accounting principles, the impact of competitive or generic products, trade buying patterns, global business operations, product liability and other types of litigation, the impact of legislation and regulatory compliance, intellectual property rights, strategic relationships with third parties, environmental liabilities, and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "Item 1A, Risk Factors." We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.


Source: Wyeth

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