Landmark antidepressant analysis demonstrated significant efficacy of Effexor®/Effexor XR
Effexor®/Effexor XR provided higher remission and emotional and physical symptom resolution rates than ssris in over 30 head-to-head studies and more than 7,000 patients
Philadelphia, PA., May 19, 2003 – Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), announced today that a landmark analysis of studies comparing antidepressant treatments demonstrated that significantly more patients achieved remission (virtual elimination) of their depression symptoms, and resolution of both emotional and physical symptoms, when treated with EFFEXOR/EFFEXOR XR (venlafaxine HCl) than with commonly used selective serotonin reuptake inhibitors (SSRIs) or placebo. The analysis was presented in two poster presentations at the American Psychiatric Association's (APA) annual meeting in San Francisco.
The analysis compared EFFEXOR®/EFFEXOR XR to the SSRIs PAXIL® (paroxetine), PROZAC® (fluoxetine), ZOLOFT® (sertraline), LUVOX® (fluvoxamine), and CELEXA (citalopram) and comprised the entire worldwide dataset of Wyeth-sponsored registration and post-marketing, published and unpublished, SSRI-controlled clinical studies of EFFEXOR/EFFEXOR XR to date.
"Given the urgency to treat a patient to remission, these data reinforce EFFEXOR XR as a first-line therapy for depression," says Dr. Eric Hollander, Professor of Psychiatry and Director of Psychopharmacology at Mount Sinai School of Medicine in New York City. "This is important information for physicians as remission is a critical milestone in preventing symptom recurrence and depression relapse."
In one poster it was determined that EFFEXOR/EFFEXOR XR-treated patients had significantly higher remission rates than those treated with the studied SSRIs using standard evaluations including scoring seven or less on the 17-item Hamilton Rating Scale for Depression (HAM-D17) and less than 10 on the Montgomery-Asberg Depression Rating Scale (MADRS).
Specifically, the HAM-D17 evaluation revealed a 41 percent remission rate for EFFEXOR/EFFEXOR XR patients, significantly greater than that of patients receiving an SSRI (35 percent, p<0.001), or a placebo (25 percent, p<0.001), based on data from 32 of 33 trials. Researchers excluded one trial with just 148 patients from all HAM-D remission calculations because it did not use this scale.
The second poster, focusing on the treatment of the physical symptoms of depression in 31 trials, documents that EFFEXOR®/EFFEXOR XR yielded significantly greater resolution of the general somatic symptoms of depression based upon the criteria of the anxiety/somatization factor of the HAM-D21 scale. Such symptoms can include pain such as headache and joint pain; gastrointestinal symptoms; sexual dysfunction; numbness, weakness or vision problems; and chronic pain. The analysis revealed that 38 percent of the EFFEXOR/EFFEXOR XR group achieved resolution of the general somatic symptoms, significantly more than the 32 percent of SSRI-treated patients and the 25 percent of placebo patients, (p<0.001 for both).
Additional remission evaluations used in the analysis included Clinical Global Impressions-Improvement (CGI-I) and Clinical Global Impressions-Severity (CGI-S) scores, as well as compatibility of participants' age, weight, duration of illness and baseline scores using HAM-D 21, MADRS and CGI-S.
Investigators in all of the double-blinded studies randomly assigned patients to receive either EFFEXOR/EFFEXOR XR or an SSRI and administered comparable average doses based on the efficacy of the medications. Nine of the studies also included placebos.
"EFFEXOR® XR is a proven serotonin-norepinephrine reuptake inhibitor (SNRI) supported by a large clinical data set obtained through studies conducted using the most rigorous efficacy measurements," says Victoria Kusiak, M.D., Vice President of Global Medical Affairs and North American Medical Director of Wyeth Pharmaceuticals. "The results of this study, the most comprehensive of its kind of which we are aware, show that EFFEXOR XR can play a significant role in helping patients achieve the goal of becoming virtually symptom-free."
More than 19 million Americans each year suffer from depression, which interferes with the ability to work, study, sleep, eat, and enjoy once pleasurable activities.
About EFFEXOR XR EFFEXOR XR is a structurally novel antidepressant chemically unrelated to any other available antidepressant. EFFEXOR XR is believed to increase levels of both serotonin and norepinephrine, two of the brain chemicals thought to be implicated in depression and anxiety disorders.
The most common adverse events reported in 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® 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, 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.
The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events that involve risks and uncertainties including, without limitation, risks associated with the inherent uncertainty of pharmaceutical research, product development, manufacturing, and commercialization, and economic conditions, including interest and currency exchange rate fluctuations, the impact of competitive or generic products, product liability and other types of lawsuits, the impact of legislative and regulatory compliance and obtaining approvals, and patents, and other risks and uncertainties, including those detailed from time to time in Wyeth's periodic reports, including quarterly reports on Form 10-Q and the Annual Report on Form 10-K, filed with the Securities and Exchange Commission. Actual results may vary materially from the forward-looking statements. The Company assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise
Media Contacts: Douglas Petkus Wyeth Pharmaceuticals (484) 865-5140 Natalie de Vane Wyeth Pharmaceuticals (484) 865-5139
Investor Contact: Justin Victoria Wyeth (973) 660-5340