The FDA has approved Wyeth’s antidepressant Effexor XR (venlafaxine), the company’s top-selling Rx drug, for the treatment of adults with panic disorder.
Effexor XR is the first drug to be approved to treat panic disorder since 2002, the company said, with about 2.4 million Americans suffering from the condition.
Last year, global sales of Effexor reached approximately $3 billion but sales of the brand have been sagging as of late, with a decrease of 4% in the third quarter of 2005 when compared with the same period last year.
Wyeth attributed the sales decline to an overall slowdown in the antidepressant market, as well as a trend towards the increasing use of generics in the category.
In October, Wyeth settled patent litigation with generic drug maker Teva that sought to manufacture a generic version of the Effexor. Terms of that deal were not disclosed.
Wyeth’s patent on venlafaxine runs out in 2008.
“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,”said Joseph Camardo, senior vice president, global medical affairs at Wyeth.