Bigger Than Prozac?
There’s a smallish buzz around a new drug called Valdoxan (agomelatine), an anti-depressant recently approved in Europe that’s being touted as more effective than Prozac and other commonly-used anti-depressants and as having virtually no side effects. To whit, from the Mirror:
“New research shows that agomelatine – the first antidepressant in over a decade – is more effective than Prozac in treating depression. And it is not associated with some of the common side-effects of antidepressant drugs such as weight gain, sleep difficulties and sexual problems.
“A study found the £30-a-month drug, also known as Valdoxan, helped 77.7 per cent of people with severe depression compared with 68.8 per cent on Prozac. The data was presented at the European Congress of Neuropsychopharmacology in Istanbul.”
That study remains unpublished and I’m skeptical of it for one reason: I’ve never, ever seen Prozac relieve depression in over two-thirds of patients in an eight-week trial, so it makes me wonder what was going on here. Also, there is apparently no placebo arm to the study.
Even more, a few years ago the French company Servier submitted Valdoxan for approval to European regulators and the drug was rejected as not having sufficient efficacy. The company resubmitted the drug and it was approved for use in Europe this past February (it’s been submitted for approval in the UK). I’ve heard little about the drug since its approval.
One sign that Valdoxan is not the greatest thing since sliced bread is that Servier licensed it in the US to Novartis and the company reportedly has no plans to submit it for FDA approval until at least 2012. If it were a hotter compound, Novartis would be banging down the FDA’s doors for approval.
All of that said, what is interesting is that Valdoxan is a melatonergic antidepressant as it’s an agonist to melatonin receptors in the brain and it apparently works to reset human sleep patterns and circadian rhythms.
It’ll be interesting to see what plays out with this drug over the next few years.
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