Pooled Studies Showed Desvenlafaxine Succinate SignificantlyImproved Painful Symptoms and Anxious Symptoms Associated withMajor Depressive Disorder in Adults, Compared With PlaceboPooled Findings Presented at 2007 APA Meeting Also Showed No Significant Impact on Weight for Desvenlafaxine Succinate
COLLEGEVILLE, Pa., May 21, 2007 /PRNewswire-FirstCall/ -- Findings from two separate pooled analyses - one examining the effect of desvenlafaxine succinate on anxious symptoms and the other on painful symptoms associated with major depressive disorder (MDD) -- as well as a separate pooled analysis that examined the effect of desvenlafaxine succinate on weight change in patients with MDD were presented today at the 2007 American Psychiatric Association (APA) annual meeting in San Diego, Calif., by Wyeth Pharmaceuticals, a division of Wyeth . The primary objective of studies included in these pooled analyses was to evaluate efficacy and safety of desvenlafaxine succinate in adults with MDD.
"People don't always connect painful physical symptoms and anxious symptoms with depression, but these can be very real symptoms of the illness," says Philip Ninan, M.D., Vice President, Neuroscience, Global Medical Affairs for Wyeth Pharmaceuticals. "In addition, weight gain is a relatively common concern of patients who are treated with antidepressants. We are encouraged by the results of these pooled analyses which show that desvenlafaxine, if approved, may be an important option for the treatment of adult patients with major depressive disorder."
The most common adverse event associated with desvenlafaxine succinate in the pooled analyses was transient nausea.
About the Studies
Poster NR366: Tourian K, et al. Improvement of Anxiety Symptoms in Patients with Major Depressive Disorder Treated with Desvenlafaxine Succinate: A Pooled Analysis
Results of a pooled analysis of seven studies showed that adult patients who took desvenlafaxine succinate experienced a greater improvement in mild and moderate symptoms of anxiety associated with depression compared with those who received placebo.
In these seven randomized, double-blind, placebo-controlled, eight-week studies evaluating the efficacy of desvenlafaxine succinate in major depressive disorder, patients were excluded if any anxiety disorder was the primary diagnosis. Eligible patients were randomly assigned to the desvenlafaxine succinate group (n=1,186) at doses ranging from 100 to 400 mg/day or placebo (n=797) for eight weeks. The efficacy outcomes for anxious symptoms were measured by using the anxiety/psychic item from the Hamilton Rating Scale for Depression (HAM-D17) and the Covi Anxiety Scale total score. Improvement from baseline to the end point (Week 8) was significantly greater for the desvenlafaxine succinate group than for the placebo group in both the HAM-D17 anxiety/psychic item and the Covi anxiety total scores.
Poster NR365: Brisard C, et al. Treating the Painful Physical Symptoms of Depression with Desvenlafaxine Succinate vs. Placebo in Depressed Outpatients
Results of a pooled analysis of six double-blind, placebo-controlled clinical trials evaluating the efficacy of desvenlafaxine succinate in MDD showed that the change from baseline on the Visual Analog Scale - Pain Intensity (VAS-PI) on the overall pain score for the total population was significantly greater in the desvenlafaxine succinate group compared with the placebo group.
Data from six double-blind, placebo-controlled clinical trials of patients taking desvenlafaxine succinate 100 to 400 mg/day (n=1,048) or placebo (n=718) were pooled for this analysis. Patients taking desvenlafaxine succinate experienced significant improvement on various subscales such as the back, chest and arms, legs and joint individual items of the VAS-PI, but the difference did not reach statistical significance from placebo on the stomach pain item of the VAS-PI.
Poster NR364: Patroneva A, et al. Analysis of Weight Change with Short- and Longer-Term Treatment with Desvenlafaxine Succinate for Major Depressive Disorder
Results of a pooled analysis of seven short-term, placebo-controlled, double-blind studies (desvenlafaxine succinate group, n=1,211; placebo group, n=803) and one long-term relapse prevention study (desvenlafaxine succinate group, n=191; placebo group, n=185) examining the effects of desvenlafaxine succinate on weight change in patients with MDD showed that persistent weight gains or losses were not observed in patients administered desvenlafaxine succinate.
Desvenlafaxine is a serotonin-norepinephrine reuptake inhibitor (SNRI) studied as a potential treatment for adult men and women with MDD. Wyeth submitted a New Drug Application (NDA) for MDD on December 22, 2005. The Company also has filed an NDA for vasomotor symptoms (VMS) associated with menopause and expects a U.S. Food and Drug Administration (FDA) action letter in the third quarter of 2007. If approved, desvenlafaxine will be the first and only non-hormonal medicine for the treatment of VMS associated with menopause. Wyeth is a leader in both neuroscience and women's health care.
Wyeth discovered and developed the first SNRI approved by the FDA, which currently is the most widely used antidepressant in the world. Desvenlafaxine represents Wyeth's latest efforts and continued commitment to developing therapies to help improve the lives of patients suffering from mental health disorders.
According to a large depression trial funded by the National Institute of Mental Health, only 28 percent of patients with depression achieved remission with initial antidepressant treatment. This leaves a large percentage of patients still suffering from depression. Clearly, additional medicines are needed for treating MDD.
Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with major depressive disorder and other psychiatric disorders. Anyone considering the use of any antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are on such 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 their prescriber.
About Major Depressive Disorder
Major depressive disorder is a serious medical condition that is different from "feeling blue" and is not something people just "get over." Criteria for major depressive disorder include five or more of the following symptoms that have been present for at least two weeks, and at least one of the symptoms must be either depressed mood or loss of interest or pleasure.
-- Depressed mood -- Loss of interest or pleasure -- Changes in appetite or weight -- Changes in sleeping patterns -- Psychomotor agitation or retardation -- Fatigue or low energy -- Feeling worthless or guilty for no reason -- Difficulty thinking or concentrating -- Thoughts of death or suicide
Further, people with major depressive disorder may experience clinically significant distress or impairment in social, occupational or other important areas of functioning. If a person experiences these symptoms, he or she should speak with a health care professional.
Major depressive disorder is a common mental disorder, affecting about 121 million people worldwide. In the United States, it is estimated that depression affects about 19 million American adults each year. The lifetime risk of major depression has been assessed from 10 percent to 25 percent for women and 5 percent to 12 percent for men. Research has shown that hormonal changes, including estrogen decline, or life stressors experienced by women may contribute to a major depressive episode.
About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, 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 non-prescription 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.
Posted: May 2007