FDA Approves PRISTIQ(TM) for the Treatment of Adult Patients with Major Depressiv...(Q as a treatment for depression was esta...)

Date:2/29/2008

Q as a treatment for depression was established in four 8-week, randomized, double-blind, placebo-controlled, fixed-dose studies in adult outpatients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for MDD. At the recommended dose of 50 mg, the discontinuation rate due to an adverse experience for PRISTIQ (4.1 percent) was similar to the rate for placebo (3.8 percent).

Side effects of many antidepressant therapies can cause some patients to stop taking their medication. The most commonly observed adverse reactions in patients taking PRISTIQ for MDD in short-term, fixed-dose studies (incidence greater than or equal to 5 percent and at least twice the rate of placebo in the 50 or 100 mg dose groups) were nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence (sleepiness), decreased appetite, anxiety, and specific male sexual function disorders.

About PRISTIQ

PRISTIQ delivers the major active metabolite of EFFEXOR XR(R) (venlafaxine HCl) in its active state without going through the CYP2D6 metabolic pathway. This could be beneficial when PRISTIQ is coadministered with other commonly prescribed medications metabolized through that pathway. EFFEXOR XR, discovered and developed by Wyeth, was the first SNRI approved by the FDA for MDD and is currently the most widely prescribed antidepressant in the world.

PRISTIQ, also discovered and developed by Wyeth, demonstrates the Company's significant and continued commitment to developing new therapies in the field of neuroscience.

About Major Depressive Disorder

Major depressive disorder (MDD) is a common mental disorder, affecting about 121 million people worldwide. In the United States, MDD affects approximately 15 million adults, or 6.7 percent of the U.S. population age 18 and older in a given year. In fact, depression is among the leading causes of disability and the fourth leading contributor to the global burden of disease. Further,
'/>"/>

SOURCE Wyeth Pharmaceuticals Copyright©2008 PR Newswire. All rights reserved

6 GOOD

Page: 1 2 3 4 5 6 7 8 9
Related biology technology :

1. FDA Approves INTELENCE(TM) (etravirine) for HIV Combination Therapy
2. FDA Approves Additional Dosage Strengths of Shires ADHD Treatment VYVANSE(TM) (lisdexamfetamine dimesylate) Which May Help Physicians Tailor Treatment for Individual Patients
3. FDA Approves New Mechanism of Action Labeling for Ranexa(R)
4. FDA Approves Diovan(R) for Treatment of High Blood Pressure in Children
5. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) as the First Medication for Add-On Treatment of Major Depressive Disorder (MDD)
6. FDA Approves New SPRYCEL(R) (Dasatinib) Product Labeling for Patients with Chronic-Phase CML
7. FDA Approves Genzymes Renvela(TM) for Dialysis Patients
8. FDA Approves IXEMPRA(TM) (ixabepilone), a Semi-Synthetic Analog of Epothilone B, for the Treatment of Advanced Breast Cancer
9. FDA Approves DORIBAX(TM) for the Treatment of Complicated Intra-Abdominal and Complicated Urinary Tract Infections
10. FDA Approves Administration of LEXIVA(R) with Lower Dose of Boosting Medication Ritonavir
11. FDA Approves New 300mg Loading Dose Tablet for PLAVIX(R) (clopidogrel bisulfate)