To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Antidepressant Effexor XR (Venlafaxine) Given FDA Approval For Generalized Anxiety Disorder URL: http://www.pslgroup.com/dg/1D9D46.htm Doctor's Guide July 17, 2000
MADISON, NJ -- July 17, 2000 -- Wyeth-Ayerst Laboratories, the pharmaceutical division of American Home Products Corporation announced that the U.S. Food and Drug Administration (FDA) has approved a new label change for its antidepressant Effexor® XR (venlafaxine HCl) Extended-Release Capsules for use as a long-term treatment for generalized anxiety disorder (GAD). Effexor XR is the first and only antidepressant now indicated for short- and long-term benefits for people with GAD. "Today's FDA decision marks a significant milestone in the treatment of GAD since, for the first time, physicians and patients have an approved long-term therapy for this disorder," says L. Patrick Gage, PhD, President, Wyeth-Ayerst Research. "Because symptoms of GAD persist for years, often decades, patients require a treatment like Effexor XR that provides long-term symptom relief from their uncontrollable, exaggerated, and persistent worries, anxiety, and tension. Effexor XR provides a treatment option that can effectively reduce symptoms of GAD to help patients get well and return to a normal life." GAD is characterized by persistent (lasting six months or longer), excessive anxiety, worry, and tension about routine life events. With the new approval, Effexor XR is now the first and only antidepressant approved as a long-term therapy for GAD, an anxiety condition that affects nearly 5 percent of people, two thirds of whom are women. GAD is one of the most common anxiety disorders contributing to the nearly US$46 billion spent annually on these conditions. The FDA reviewed data from two randomized, double-blind, placebo-controlled trials of 595 patients in the United States, which showed that Effexor XR (venlafaxine HCl) provided significant improvements in symptoms of generalized anxiety disorder (GAD) for up to six months, compared with placebo. These long-term studies found that patients with GAD who were treated with Effexor XR experienced significant reductions in symptoms of anxiety, based on various psychiatric measures including the Hamilton Anxiety Scale (HAM-A), as well as the more specific HAM-A psychic anxiety factor score. Treatment benefits were maintained, and further improvement shown, for up to six months. Additionally, more patients treated with Effexor XR reported symptom improvement -- based on the Hospital Anxiety and Depression Scale (HAD) anxiety subscale -- as compared with placebo, and more showed a normalization of social impairment. "Effexor XR is the only antidepressant proven effective as first-line therapy for both short- and long-term treatment of GAD," says Dr. Gage. "This new data is important from a treatment perspective because, unlike some anti-anxiety medications, the long-term use of Effexor XR has not been associated with potential dependence." Effexor XR, a once-daily formulation, received FDA marketing clearance for the treatment of depression in 1997. Unlike the selective serotonin reuptake inhibitors (SSRIs) Prozac, Paxil, Zoloft, and Celexa, which selectively inhibit the reuptake of only the neurotransmitter serotonin, Effexor XR (venlafaxine HCl) inhibits the reuptake of both serotonin and norepinephrine. In 1999, Effexor XR received approval for the treatment of generalized anxiety disorder (GAD) based on clinical studies supporting symptom improvement for up to eight weeks. This new label change for long-term use in GAD reinforces the efficacy of Effexor XR for up to six months in patients with this disorder. The most common adverse events reported in Effexor XR placebo-controlled depression trials (incidence >10 percent and >2x that of placebo) were nausea, dizziness, somnolence, abnormal ejaculation, sweating, dry mouth, and nervousness; and in GAD trials were nausea, dry mouth, insomnia, abnormal ejaculation, anorexia, constipation, nervousness, 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. Three percent of Effexor XR patients in depression studies (doses of 75 to 375 mg/day), and 0.4 percent in GAD studies (doses of 75 to 255 mg/day), had sustained BP elevations. The incidence of sustained increases in BP at doses greater than 300 mg/day has not been fully evaluated. Less than 1 percent discontinued treatment because of elevated BP. Experience with immediate release venlafaxine in depression studies showed that sustained hypertension was dose related, increasing from 3 percent to 7 percent at doses of 100 to 300 mg/day, to 13 percent at doses above 300 mg/day. Regular BP monitoring is recommended. Related links: Effexor, Wyeth-Ayerst Laboratories. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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