PristiqTreatment for Depression
Update: Pristiq (desvenlafaxine) Now FDA Approved for Depression - February 29, 2008
FDA Cancels Advisory Committee Meeting to Review Desvenlafaxine Succinate Data for Major Depressive Disorder
MADISON, N.J., August 22, 2006 -- Wyeth announced today it was notified by the U.S. Food and Drug Administration (FDA) of the Agency's decision to cancel its September 7, 2006 Psychopharmacologic Drugs Advisory Committee meeting. The meeting was originally scheduled 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. After further review of the data, the FDA decided it was no longer necessary to hold the advisory committee meeting before issuing its action letter, which is expected in October 2006.
Wyeth is encouraged by this development and believes that its comprehensive clinical trials program for desvenlafaxine succinate supports the product's approval. The Company submitted its NDA to the FDA for desvenlafaxine succinate, a dual serotonin-norepinephrine reuptake inhibitor, in December 2005.
Facts About Depression
Depression is the most common serious mental disorder worldwide.
- Depression affects approximately 121 million people worldwide and is the fourth leading cause of disability and premature death.
- The World Health Organization projects that by the year 2020, depressive disorders will become the second-leading cause of disability worldwide.
- Depression is one of the most prevalent mental health conditions in the United States, affecting approximately 14.8 million American adults each year.
- Women suffer from depression twice as often as men.
- Researchers estimate that approximately 50 to 60 percent of patients suffering from depression respond to antidepressant therapy, leaving a large percentage of patients with unresolved depression.
- Patients who experience one episode of depression have a 50 to 60 percent chance that it will recur.
- Wyeth Submits Two NDAs for Women's Health Therapies June 26, 2006
- Wyeth Submits NDA for Desvenlafaxine Extended Release December 22, 2005
Posted: August 2006
- FDA Approves Pristiq for the Treatment of Adult Patients with MajorDepressive Disorder - March 3, 2008
- Wyeth Receives Approvable Letter from FDA for Pristiq for the Treatment of Vasomotor Symptoms Associated with Menopause - July 24, 2007
- Wyeth Receives Approvable Letter From FDA for Pristiq (Desvenlafaxine Succinate) for the Treatment of Major Depressive Disorder - January 23, 2007
- Re-formatted Data Submission Results in Extension of FDA Review for Desvenlafaxine Succinate - August 29, 2006
- Wyeth Submits Two New Drug Applications for Women's Health Therapies - June 26, 2006
- Wyeth Submits New Drug Application for Desvenlafaxine Extended Release (DVS-233) for Depression - December 22, 2005