Actavis announced that the Food and Drug Administration (FDA) has approved Viibryd (vilazodone HCl) tablets in a new 20mg dosage strength.
Viibryd is a selective serotonin reuptake inhibitor and 5-HT1A receptor partial agonist indicated for the treatment of major depressive disorder (MDD). It is already available in a 40mg strength.
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The supplemental new drug application (sNDA) approval was based on data from a 10-week, multi-center, double-blind, placebo-controlled and active-comparator, parallel-group, fixed-dose trial of adults with MDD (n=1,133). The primary efficacy outcome was the mean change in Montgomery-Asberg Depression Rating Scale (MADRS) total score from baseline to Week 10. A significantly greater reduction in mean MADRS total scores from baseline to Week 10 was seen in both vilazodone treatment groups (least square mean difference: vilazodone 20mg/day, 40mg/day: -2.6, -2.8 respectively) vs. placebo.
The new 20mg strength tablets are now available in pharmacies.
For more information call (800) 432-8534 or visit Actavis.com.