Initially, the makers of Brintellix suggested the drug was a "novel multimodal anti-depressant" with new treatment possibilities.
The basis of the recent FDA approval was that Brintellix proved moderately better than placebo.
Clinical trials by the drugmaker Lundbeck compared the drug to placebo. The drug has not been compared to other FDA-approved antidepressants.
Brintellix gained FDA approval in October of 2013.
In a company press release, the drug's primary mechanism of action is inhibition of serotonin reuptake, which puts Brintellix (vortioxetine) in the same basic drug class as Prozac (fluoxetine).
However, Brintellix has additional and unique chemical qualities. One unique quality is that the antidepressant enhances memory in rats. However, it isn't yet known if the drug improves memory in humans.
The company notes the drug is "the first and only compound with this combination of pharmacodynamic activity."
"Since medications affect everyone differently, it is important to have a variety of treatment options available for patients who suffer from depression." said Mitchell Mathis, M.D., acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research.
The side effects of Brintellix are similar to Prozac and other antidepressants in the same class. The most common side effects were nausea, constipation and vomiting. Similar to other antidepressants, severe side effects include:
- For children, adolescents and young adults ages 18 to 24 during initial treatment, there is increased the risk of suicidal thoughts and behavior
- For adults older than 24 years of age, there does not appear to be an increased risk of suicidal thoughts and behavior
- For adults ages 65 and older, there appears to be a reduced risk of suicidal thoughts and behavior
For more information see, http://us.brintellix.com.