After a dearth of new antidepressant entries to the U.S. drug market, the FDA approved Brintellix (vortioxetine) for the treatment of depression in September, 2013. This approval comes on the heels of the FDA’s approval of Fetzima® in July, 2013 – which I’ve written about in a previous blog.
So what is Brintellix, how does it work and does it provide any clear-cut advantages over currently available agents?
Well, like SSRIs, it’s a serotonin reuptake inhibitor. It’s also an “agonist” – better known as an activator of a specific serotonin receptor subtype – the 5HT1A serotonin receptor. You may be aware that the drugs Buspar, Viibryd and Abilify are also agonists of this receptor. This sounds like promising stuff, but it’s worth noting that none of these agents distinguished themselves remarkably for the treatment of depression in spite of their so-called “novel” status. And even more important, receptor-binding capabilities are overrated and denote advantages that are mostly theoretical in nature. Translation: You can’t count on a drug’s chemistry to provide the intended effect.
Brintellix’s approval is based on the usual and customary placebo studies which revealed that the effective dosage range of Brintellix is from 5 to 20mg daily.
I see no clear-cut advantages of Brintellix over its competitors. As for side effects, nausea was the most commonly reported adverse event, while weight gain was negligible – a plus worth mentioning.
I doubt that Brintellix will be any more than other antidepressants in a long line of “me too” agents trying to stake a claim in the very saturated antidepressant market. And of course, its price tag will be top drawer.