PristiqTreatment for Depression
Update: Pristiq (desvenlafaxine) Now FDA Approved for Depression - February 29, 2008
Wyeth Submits New Drug Application for Desvenlafaxine Extended Release (DVS-233) for Depression
MADISON, N.J., December 22, 2005 -- Wyeth Pharmaceuticals, a division of Wyeth , announced today that it has submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for desvenlafaxine extended release (DVS-233) for the treatment of major depressive disorder (MDD). Desvenlafaxine extended release represents Wyeth's ongoing commitment to research and development of new antidepressant therapies. The new compound was discovered and developed by Wyeth Research.
The clinical development program for major depressive disorder supporting the NDA investigated desvenlafaxine extended release, a serotonin/norepinephrine reuptake inhibitor (SNRI), in patients with a broad range of symptoms associated with depression, including both emotional and somatic symptoms.
"We know from clinical studies as well as clinical practice that there remain significant unmet needs in treating depressed patients," says Gary L. Stiles, M.D., Executive Vice President, Chief Medical Officer, Wyeth. "If approved, desvenlafaxine extended release will offer physicians a new clinically proven option for treating depression."
Facts About Depression
Following are facts that substantiate the significant unmet patient need for efficacy in antidepressants and the enormous societal impact of 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 the most prevalent mental health condition in the United States, affecting approximately 19 million American adults each year.
- Studies indicate that depressive episodes occur twice as frequently in women as in men.
- Depressed mood most of the day, nearly every day (subjectively reported or observed by others)
- Markedly diminished interest or pleasure in all, or almost all, activities most of the day, nearly every day (subjectively reported or observed by others)
- Significant weight loss when not dieting or weight gain, or decrease or increase in appetite nearly every day
- Insomnia or hypersomnia nearly every day
- Psychomotor agitation or retardation nearly every day (as observable by others, not merely subjective feelings)
- Fatigue or loss of energy nearly every day
- Feelings of worthlessness or excessive or inappropriate guilt (which may be delusional) nearly every day
- Diminished ability to think or concentrate, or indecisiveness, nearly every day (subjectively reported or observed by others)
- Recurrent thoughts of death (not just fear of dying), recurrent suicidal ideation without a specific plan, or a suicide attempt or a specific plan for committing suicide
- 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 percent chance that it will recur within five years.
Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with MDD and other psychiatric disorders. Anyone considering the use of any antidepressant in a child or adolescent must balance the 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.
Posted: December 2005
- FDA Approves Pristiq for the Treatment of Adult Patients with Major Depressive 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
- FDA Cancels Advisory Committee Meeting to Review Desvenlafaxine Succinate Data for Major Depressive Disorder - August 22, 2006
- Wyeth Submits Two New Drug Applications for Women's Health Therapies - June 26, 2006