FDA Approves Effexor XR Approved for Panic Disorder Treatment

Main Category: Psychology / Psychiatry
Article Date: 28 Nov 2005 - 2:00 PST

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Wyeth (NYSE:WYE) announced that on November 18, 2005, the US Food and Drug Administration (FDA) approved EFFEXOR XR® (venlafaxine HCl) for the treatment of adults with panic disorder. This marks the first antidepressant approved for panic disorder since 2002.

Panic disorder affects 2.4 million American adults annually. It is characterized by recurrent, unexpected panic attacks; i.e., a discrete period of intense fear or discomfort in the absence of real danger, where four of 13 specific symptoms such as accelerated heart rate, shortness of breath, trembling or fear of dying develop abruptly, reach a peak within 10 minutes, and are followed by at least one month of persistent concern about having another panic attack. In one study, less than 20 percent of sufferers were diagnosed and treated to remission. Because panic disorder is under recognized and not always treated to remission, patients are likely to experience a chronic and cyclical course of symptoms.

"Given the complicated, recurrent nature of panic disorder, it is imperative that physicians have new and effective treatment options, like EFFEXOR XR, to offer patients," says Alexander Bystritsky, M.D., professor of psychiatry at the David Geffen School of Medicine at UCLA and director of the UCLA Anxiety Disorders Program.

The efficacy of EFFEXOR XR as a treatment for panic disorder was established in two double-blind, 12-week, placebo-controlled studies. Adult patients received fixed doses of 75 or 150 mg/day in one study and 75 or 225 mg/day in the other study. In these studies, EFFEXOR XR was significantly more effective than placebo at all three doses.

In a long-term (26-week), double-blind study, adult patients who had responded to EFFEXOR XR (75 to 225 mg/day) during an initial 12-week open-label phase were randomly assigned to continue the same EFFEXOR XR dose (75, 150 or 225 mg) or switch to placebo for a six-month double-blind treatment phase. Patients who continued to receive EFFEXOR XR experienced a significantly longer time to relapse as compared to those patients who were switched to placebo.

Panic disorder may be associated with conditions such as depression or other anxiety disorders. EFFEXOR XR, a serotonin-norepinephrine reuptake inhibitor, is indicated not only for panic disorder but also for the treatment of adults with major depressive disorder, generalized anxiety disorder (GAD) or social anxiety disorder (SAD).

"The approval of this indication at this stage in the life-cycle of EFFEXOR XR underscores Wyeth's commitment to improving the lives of patients with mood disorders," says Joseph Camardo, M.D., Senior Vice President, Global Medical Affairs, Wyeth Pharmaceuticals.

ABOUT EFFEXOR XR

Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of EFFEXOR XR (venlafaxine HCl) or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on 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 the prescriber. EFFEXOR XR is not approved for use in pediatric patients.

EFFEXOR XR is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs). Adult and pediatric patients taking antidepressants can experience worsening of their depression and/or the emergence of suicidality. Patients should be observed closely for clinical worsening and suicidality, especially at the beginning of drug therapy, or at the time of increases or decreases in dose. Anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania, and mania have been reported and may represent precursors to emerging suicidality. Stopping or modifying therapy should be considered especially when symptoms are severe, abrupt in onset, or not part of presenting symptoms. Treatment with venlafaxine is associated with sustained increases in blood pressure (BP) in some patients. Pre-existing hypertension should be controlled. 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. The most common adverse events reported in EFFEXOR XR short-term placebo-controlled depression, generalized anxiety disorder (GAD), and/or social anxiety disorder trials (incidence >=10 % and >= 2x that of placebo) were anorexia, asthenia, constipation, dizziness, dry mouth, ejaculation problems, impotence, insomnia, nausea, nervousness, somnolence, and sweating.

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, 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 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.

www.wyeth.com