Wyeth Pharmaceuticals,
a division of Wyeth (NYSE: WYE), this week presented for the first time
phase 3 data and results from other studies concerning its investigational
drug for major depressive disorder (MDD), desvenlafaxine succinate
(DVS-233), a novel serotonin-norepinephrine reuptake inhibitor (SNRI) at
the 2006 American Psychiatric Association Annual Meeting in Toronto.
Overall, the phase 3 data results showed desvenlafaxine succinate
significantly improved depressive symptoms in adult patients compared to
placebo. In a separate study investigating QTc prolongation involving
healthy adult female subjects, desvenlafaxine succinate 200 mg and 600 mg
doses did not affect the QT interval at the study's primary endpoint at
eight hours post dose. Studying a drug's effect on the QT interval is one
of many methods used to help determine a drug's overall safety profile.
Wyeth Research discovered and developed desvenlafaxine succinate. In
December 2005, Wyeth submitted a New Drug Application (NDA) to the U.S.
Food and Drug Administration (FDA) for desvenlafaxine succinate for the
treatment of MDD.
"The phase 3 data showed that desvenlafaxine succinate can help improve
symptoms in adult patients suffering with depression," says Nicholas A.
DeMartinis, M.D., Assistant Professor and Associate Director of Clinical
Operations of the Neuropsychopharmacology Treatment Research and Training
Center at the University of Connecticut Health Center and principal
investigator of the clinical trial presented in the scientific session.
"Because a substantial number of patients with depression do not respond to
current antidepressant treatments, it is important that new treatments
continue to be developed to provide patients and physicians with additional
treatment options," Dr. DeMartinis adds.
"Wyeth is pleased to be able to report these promising findings that
have the potential to add value to the management and treatment of major
depressive disorder," says Philip Ninan, Vice President, Neuroscience,
Global Medical Affairs. "As a leader in neuroscience, Wyeth is committed to
its continuing development of medications that help address the unmet needs
of people living with mental illness."
Abstract: Efficacy and Safety of Desvenlafaxine Succinate in the
Treatment of Major Depressive Disorder.
The results of the first study presented, a phase 3, multicenter,
randomized, double-blind clinical trial of desvenlafaxine succinate in 461
adult patients with MDD, showed significant reduction in Hamilton
Depression Rating Scale (HAM-D17) scores for the desvenlafaxine succinate
100 mg (p = .0038) and 400 mg (p=0.0023) dose groups versus the placebo
group. For the 200 mg dose group, reduction in the HAM-D17 trended towards
significance (p=0.0764). All desvenlafaxine succinate dose groups showed
significant improvement on the Clinical Global Impression-Improvement
(CGI-I) scale, a secondary efficacy measure, versus placebo (p< 0.05).
Additionally, the 100 mg desvenlafaxine succinate group demonstrated
significant improvement versus placebo in depression-related pain scores
utilizing the Visual Analog Scale- Pain Intensity (VAS-PI) scale (p=0.002).
Abstract: Randomized, Double-Blind, Placebo-Controlled Study of
Desvenlafaxine Succinate in Major Depressive Disorder
The results of a second phase 3, randomized, double-blind, placebo-
controlled study of desvenlafaxine succinate were also presented at the APA
annual meeting. In this second study, 375 adult patients with major
depressive disorder were randomized to receive desvenlafaxine succinate
once- daily doses of 200 mg, 400mg, or placebo. Adjusted mean change from
baseline in HAM-D17 total score, the primary efficacy measure, was
significantly greater for the desvenlafaxine succinate 200 mg (p=0.002) and
400 mg (p=0.008) dose groups versus placebo. In addition, overall VAS-PI
scores for the desvenlafaxine succinate 200 mg group were significantly
better than placebo (p=.002). There was a trend toward significance for the
desvenlafaxine succinate 400 mg group (p=0.053).
In the two phase 3 desvenlafaxine succinate clinical trials presented
at the APA, adverse events, including nausea and increased blood pressure,
were generally consistent with the SNRI class. The incidence of nausea was
greatest during week 1 of treatment and decreased dramatically afterwards
to rates that remained low for the remainder of the study. The most common
treatment emergent adverse events (i.e., those reported by at least 10
percent of desvenlafaxine succinate patients, and twice the rate of
patients on placebo) were abdominal pain, asthenia, anorexia, constipation,
dry mouth, nausea, vomiting, dizziness, insomnia, nervousness, somnolence,
sweating, tremor, vertigo, and abnormal ejaculation. Most of these adverse
events in both studies were mild or moderate in severity.
Abstract: Double-blind, Placebo- and Moxifloxacin-controlled Crossover
Study of the Effects of Desvenlafaxine Succinate on QT Interval in Healthy
Adult Female Subjects
To help determine whether desvenlafaxine succinate had effects on the
QT interval, a randomized, double-blind study of 71 healthy adult women
(ages 18 to 55) was conducted. In the study, desvenlafaxine succinate 200
mg and 600 mg dose groups did not affect the QT interval at the primary
endpoint at eight hours post dose. Because many drugs are known to be
associated with a potential to prolong QT interval, the FDA developed
guidance recommending that all manufacturers conduct a QT interval study to
help determine whether any new agent may potentially prolong the QT/QTc
interval, one of many important measures of cardiovascular safety.
Abstract: Desvenlafaxine: Preclinical Evidence for Serotonin and
Norepinephrine Reuptake Inhibition, Antidepressant, and Antinociceptive
Activity
According to research also presented during the APA, desvenlafaxine
succinate exhibited activity in preclinical models of depression and
anxiety.
Facts About Depression
Following are facts that substantiate the significant unmet patient
need for additional antidepressant treatment options and the enormous
societal impact of depression.
Depression is the most common serious mental disorder worldwide.
-- Depression affects approximately 121 million people worldwide and is
the fourth leading cause of disability and premature death.
-- The World Health Organization projects that by the year 2020,
depressive disorders will become the second-leading cause of disability
worldwide.
-- Depression is one of the most prevalent mental health conditions in the
United States, affecting approximately 14.8 million American adults
each year.
-- Women suffer from depression twice as often as men.
More treatment options are needed.
-- Researchers estimate that approximately 50 to 60 percent of patients
suffering from depression respond to antidepressant therapy, leaving a
large percentage of patients with unresolved depression.
-- Patients who experience one episode of depression have a 50 to 60
percent chance that it will recur.
Depression is both a physical and mental illness.
The most common symptoms include:
-- Feelings of hopelessness and sadness
-- Crying, thoughts of death or suicide
-- Lack of motivation
-- Changes in appetite and weight
-- Feelings of guilt for no apparent reason
-- Changes in sleep patterns
-- Loss of interest in activities or friends
-- Trouble concentrating
-- Headache
-- Pains in the chest, back, joints and muscles
-- Gastrointestinal complaints
Wyeth Is Committed to Neuroscience Research and Development
As a leader in neuroscience, Wyeth's discovery and development of
desvenlafaxine succinate demonstrates its commitment to developing
pharmaceutical products to help address the unmet needs of patients living
with mental illness. In addition to the investigational compound
desvenlafaxine succinate for major depressive disorder, the Company also
has active research programs in mental health areas, including bipolar
disorder, schizophrenia, and Alzheimer's disease.
About Antidepressants
Antidepressants increased the risk of suicidal thinking and behavior
(suicidality) in short-term studies in children and adolescents with MDD
and other psychiatric disorders. Anyone considering the use of any
antidepressant in a child or adolescent must balance the 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.
About 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.
Wyeth
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