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Wyeth’s Effexor approved for panic disorder

The FDA has approved Wyeth's antidepressant Effexor XR for the treatment of adults with panic disorder.

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

In a long-term, 26-week study, adult patients who had responded to Effexor XR during an initial 12-week phase were randomly assigned to continue on the same dose of the drug or switch to placebo for a further six-months of treatment. Patients who continued to receive the drug 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 or social anxiety disorder.

Panic disorder affects 2.4 million American adults annually. It is characterized by recurrent, unexpected panic attacks which take the form of a discrete period of intense fear or discomfort in the absence of real danger. There are 13 specific symptoms of panic disorder including accelerated heart rate, shortness of breath, trembling or fear of dying.

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,” said Dr Alexander Bystritsky, director of the UCLA Anxiety Disorders Program.