The Psychopharmacologic Drugs Advisory Committee meeting was scheduled for September 7, 2006 to provide a forum for FDA advisors to discuss and review data included in Wyeth’s new drug application (NDA) for desvenlafaxine succinate extended release for the treatment of major depressive disorder.
However, after further review of the data, the FDA decided that it was no longer necessary to hold the advisory committee meeting before issuing its action letter, which is expected in October 2006.
Wyeth said that it is encouraged by this development and believes that its comprehensive clinical trials program for desvenlafaxine succinate, which is also known as DVS-233, supports the product’s approval.
Wyeth submitted its NDA for desvenlafaxine succinate, a dual serotonin-norepinephrine reuptake inhibitor, in December 2005. The drug candidate is widely seen to have great commercial potential, which appears to be reflected by shareholders’ positive reaction to the news.