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Vilazodone Approved

The FDA announced that PGxHealth’s Vilazodone (Viibryd) has been approved for the treatment of major depression. Vilazodone is yet another serotonin reuptake inhibitor with a few other pharmacological twists.

No matter what you think of the SSRIs, they have been battle-tested for a long time. When you combine the regulatory environment with drug companies looking for a quick score, you have to look somewhat skeptically at the safety and efficacy of any new antidepressant. But, hopefully, this drug works well for those who have struggled to get relief from the antidepressants currently on the market.

According to the drug’s manufacturer, PGxHealth, the approval was based primarily on two eight-week clinical trials comparing vilazodone with placebo. The drug was also tested in a 52-week uncontrolled study with efficacy results similar to those seen in the randomized trials.

Vilazodone’s label will include a boxed warning and about risks of suicidal thinking and behavior in patients younger than 25 years old.