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Data Presented for the First Time on 50 mg/Day Dose for PRISTIQ for the Treatment of Major Depressive Disorder
COLLEGEVILLE, PA, USA | December 12, 2007 | Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announces that data from two Phase 3 clinical studies of PRISTIQ™ (desvenlafaxine), an investigational serotonin-norepinephrine reuptake inhibitor (SNRI), showed that adult patients who received a 50 mg/day dose of PRISTIQ for the treatment of major depressive disorder (MDD) experienced a statistically significant reduction in the symptoms of major depression compared to placebo. The two studies, which evaluated efficacy and safety of PRISTIQ for the treatment of MDD at fixed doses of 50 mg/day and 100 mg/day, will be presented today at a major medical meeting. This will be the first time an analysis of the 50 mg/day dose for PRISTIQ for the treatment of MDD is presented.
In both studies, discontinuation rates due to adverse events (AEs) for PRISTIQ 50 mg/day were similar to placebo. In the two studies, the rates of discontinuation due to AEs for placebo and PRISTIQ 100 mg/day were three percent and seven percent, respectively.
“These findings show that PRISTIQ has the potential to reduce symptoms of MDD at doses as low as 50 mg once daily,” says Philip Ninan, M.D., Vice President, Neuroscience, Global Medical Affairs. “The response rates of patients in the 50 mg/day dose groups are similar to the rates seen at higher doses. We are also encouraged by the tolerability profile shown in the two studies presented at this meeting. Notably, subjects in the 50 mg/day dose groups were not titrated from a lower dose when initiating therapy.”
Wyeth submitted in August 2007 the results of the two studies to the U.S. Food and Drug Administration (FDA) as part of its complete response to the FDA approvable letter it received in January 2007 for PRISTIQ for the treatment of MDD. FDA action on the application is expected during the first quarter of 2008. The clinical data for PRISTIQ presented at the meeting represent only a portion of the data from the ongoing clinical development of PRISTIQ and are not necessarily representative of the totality of data and other information that may affect further development, regulatory review and/or commercialization of PRISTIQ.
More About the Studies
Poster 145: Liebowitz M., et al. Evaluation of the Efficacy and Safety of Fixed Doses of Desvenlafaxine Succinate at 50 mg and 100 mg in Outpatients with Major Depressive Disorder in 2 Placebo-Controlled Trials
Data presented are from two identically designed multicenter, randomized, double-blind, placebo-controlled, eight-week studies, one conducted outside of the United States involving 483 adult patients, and one in the U.S. with 447 adult patients. Primary efficacy in both trials was determined based on change from baseline score on the 17-item Hamilton Depression Rating Scale (HAM-D17). Patients in both desvenlafaxine groups started treatment at 50 mg/day. For the 100 mg/day group, the dose was increased to 100 mg/day on the eighth day of the study.
Efficacy Analysis
The results of both trials showed that at the 50 mg/day dose, desvenlafaxine was associated with a significant reduction in the symptoms of MDD as measured by HAM-D17 scores over eight weeks compared with placebo (ex-US: p=0.002, 50 mg = -13.2, placebo = -10.7; U.S.: p=0.018, 50 mg = -11.5, placebo = -9.5). While the 100 mg/day dose showed a statistically significant improvement in the international study versus placebo (p<0.001, 100 mg = -13.7), this dose did not statistically separate from placebo in the U.S. study (p=0.065, 100 mg = -11.0).
Safety Analysis
In the U.S. study, rates of discontinuation due to AEs for the placebo, desvenlafaxine 50 mg/day and desvenlafaxine 100 mg/day groups were 3 percent, 3 percent and 7 percent, respectively. In the international study, these rates for the placebo, desvenlafaxine 50 mg/day and desvenlafaxine 100 mg/day groups were 3 percent, 5 percent and 7 percent, respectively.
Adverse events in both of these studies that were reported by at least five percent of the subjects and twice the rate of placebo included asthenia, anorexia, anxiety, dizziness and insomnia. Events also reported by at least five percent of the subjects and twice the rate of placebo in the international study were nausea, somnolence and abnormal ejaculation; and in the U.S. study they were constipation, dry mouth, myalgia, impotence and sweating. In the U.S. study, nausea was not among the adverse events reported by at least five percent of the subjects and twice the rate of placebo.
A PDF version of the poster presentation of this data will be available on Wyeth’s website, www.Wyeth.com, shortly after it is presented today, beginning at 5:30 p.m., Eastern U.S.Time.
“Major depressive disorder is a chronic and disabling disease that can cause significant distress and impair an individual’s daily functioning,” says Michael Liebowitz, M.D., lead author of the poster and a professor of clinical psychiatry. “Unfortunately, research and clinical practice suggest that a large percentage of patients with major depression do not respond to initial antidepressant therapy, leaving these patients still struggling with symptoms of depression. Clearly, there is a need for additional treatment options.”
Desvenlafaxine was discovered and developed by Wyeth Research. As a leader in neuroscience, the Company is committed to discovering and developing a broad range of treatments for mental illness.
About Antidepressants
Antidepressants, including selective serotonin reuptake inhibitors (SSRIs) and SNRIs, increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and 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, 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.
SOURCE: WYETH
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