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| |  Effexor XR Approved In The U.S. For Anxiety MADISON, NJ -- March 12, 1999 – The United States Food and Drug Administration has approved a new indication for Wyeth-Ayerst Laboratories’ Effexor(R) XR (venlafaxine HCl) Extended-Release Capsules, for the treatment of Generalised Anxiety Disorder (GAD). The drug is already indicated for the treatment of depression. Effexor XR is the first and only antidepressant proven effective in relieving GAD. Generalised Anxiety Disorder is one of the most prevalent anxiety disorders, estimated to affect approximately five percent of people; nearly two thirds of whom are women. People with Generalised Anxiety Disorder experience excessive anxiety and worry about everyday routine life events. These persistent symptoms last for at least six months and are difficult to control. Other common symptoms include feeling restless and on edge, easily tired, trouble concentrating, irritability, muscle tension and sleep disturbance. "From a doctor's perspective, Generalised Anxiety Disorder is a serious condition which can significantly impact a person's daily functioning," said Jonathan Davidson, M.D., director of anxiety traumatic stress program, department of psychiatry, Duke University Medical Center, Durham, N.C. "The new indication for Effexor XR offers patients an important single, daily treatment option for Generalised Anxiety Disorder, which has had limited treatment options to date. “Effexor offers a new once-daily first-line treatment with a favourable tolerability profile for patients with Generalised Anxiety Disorder." The approval was based on the results of two short-term, double-blind, placebo-controlled trials involving 782 patients with Generalised Anxiety Disorder. The trials were the first to successfully demonstrate the efficacy of an antidepressant in treating patients with GAD who did not have major depressive disorder. In the first study, patients were treated with a daily dose of either 75, 150, or 225 milligrams (mg) of Effexor XR or a placebo for eight weeks. The second study included patients treated with either Effexor XR (75 and 150 mg) or a placebo for eight weeks. In both studies, patients treated with Effexor XR demonstrated statistically significant reductions in anxiety symptoms versus the placebo groups, based on standard psychiatric measures: Hamilton Anxiety (HAM-A) total score, the HAM-A Anxiety and Tension Items and the Clinical Global Impressions (CGI) Severity of Illness Items. "These results demonstrate that Effexor XR is an effective medication for Generalised Anxiety Disorder," Dr. Davidson said. "This is important news for patients who are looking for relief of GAD symptoms, as well as for patients who suffer from depression with associated symptoms of anxiety." Anxiety disorders, which include Generalised Anxiety Disorder, affect more than 23 million Americans each year at a cost of more than $46 billion US. In addition, many patients diagnosed with Generalised Anxiety Disorder may also experience depressive symptoms. Generally, patients with psychiatric disorders such as Generalised Anxiety Disorder and depression may have difficulty carrying out daily activities and often seek professional help and receive medication. Effexor XR, a once-daily formulation, received FDA marketing clearance for the treatment of depression in 1997. Unlike the selective serotonin reuptake inhibitors (SSRIs) such as Prozac(R), which selectively inhibit the reuptake of one neurotransmitter, serotonin, in the brain, Effexor XR is a potent inhibitor of the reuptake of both serotonin and norepinephrine. Effexor XR is contraindicated in patients known to be hypersensitive to venlafaxine hydrochloride and in patients taking monoamine oxidase inhibitors (MAOIs). Because of the potential for serious adverse reactions, Effexor XR should not be used in combination with an MAOI or within at least 14 days of discontinuing treatment with an MAOI. Based on the half-life of venlafaxine, at least seven days should be allowed after discontinuing use of Effexor XR before starting a MAOI. Treatment with venlafaxine is associated with sustained increases in blood pressure (BP) in some patients. Three percent of Effexor XR patients in depression studies (with doses of 75 to 375 mg/day) and 0.4 percent in Generalised Anxiety Disorder studies (with doses of 75 to 255 mg/day) had sustained BP elevations. The incidence of sustained increases in blood pressure at doses greater than 300 mg/day has not been fully evaluated. Less than one percent discontinued treatment because of elevated BP. Experience with the immediate-release form of Effexor in depression studies showed that sustained hypertension was dose related, increasing from three percent to seven percent at doses of 100 to 300 mg/day, to 13 percent at doses above 300 mg/day. Regular BP monitoring is recommended. The most common adverse events reported in Effexor XR placebo-controlled depression trials (incidence greater than or equal to 10 percent and greater than or equal to two times that of placebo) were nausea, dizziness, somnolence, abnormal ejaculation, sweating, dry mouth and nervousness; and in Generalised Anxiety Disorder trials were nausea, dry mouth, insomnia, abnormal ejaculation, anorexia, constipation, nervousness and sweating.
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