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Saturday, September 19, 2009

New Antidepressant to hit the market





Just when you thought it was safe to complain of SSRi withdrawal to your doctor or the medicines regulator along comes yet another form of antidepressant by the name of Valdoxan [agomelatine].

Valdoxan, developed by the pharmaceutical company Servier, hit one of the UK tabloids earlier this week which prompted a few of my readers to write me.

The article from The Daily Mirror ran with the headline: "The new Prozac?" and it was claimed that Valdoxan helped 77.7 per cent of people with severe depression compared with 68.8 per cent on Prozac.

Further research showed that agomelatine is apparently comparable to paroxetine (Seroxat, Paxil) and sertraline (Lustral, Zoloft), two SSRI antidepressants, in the treatment of major depression.[1] Agomelatine showed benefits over sertraline and paroxetine due to the lack of sexual side effects and discontinuation side effects. According to the Daily Mirror's, Emily Cook, the drug costs a staggering £30 per month and it is not associated with some of the common side-effects of antidepressant drugs such as weight gain, sleep difficulties and sexual problems.

No mention of suicidal thoughts then?

Honestly, it just defies all belief. A pharmaceutical company claims it works so we roll out the red carpet for it?

What of the long term effects? Well, like GSK's Seroxat there obviously has been no study into prolonged use of this particular miracle pill but I doubt if that will stop the MHRA, the UK medicine regulator, granting an approval for it.

Poor old Prozac, once the king of kings in the antidepressant world - it took a stranglehold on the market when benzos took a bad rap, it then, itself, took a kick to the gonads when Seroxat was launched by GSK - they played on the fact that people were feeling suicidal on Prozac - Pot, kettle and black springs to mind.

So, here we have yet another pill that proclaims to fix a dose of the blues, yet again it is being rivalled against a popular SSRi in Prozac, just the same way Seroxat was when it was first marketed.

No doubt the pharmaceutical reps have already been briefed about possible questions from doctors, such as, 'Can it be used in children?', Does the side effects include suicidal thoughts?' etc.

Valdoxan is known as a norepinephrine dopamine disinhibitor [NDDI] because of its 5HT2C antagonistic properties of inhibiting 5HT, thereby disinhibiting DA and NE release by enhancing the activity of frontocortical dopaminergic and adrenergic pathways [2,3]

The Q&A's on Servier's webpage proves interesting. They [Servier] claim:

"The antidepressant efficacy of VALDOXAN has been confirmed in four trials versus placebo, three over the short term and one over the long term. The antidepressant efficacy of VALDOXAN is significantly superior to that of placebo, as mentioned in the Valdoxan SPC, whatever the symptom intensity, including the more severely depressed patients."

They also claim, "This long-term antidepressant efficacy of Valdoxan has recently been confirmed over 10 months of treatment."

The most common side effects are announced in typical pharma fashion with, "VALDOXAN is very well tolerated. The most common adverse reactions are nausea and dizziness. Adverse reactions are usually mild or moderate and occur within the first 2 weeks of treatment."

Didn't Dr. Benbow [GSK] say that about Seroxat?

Let's take a listen shall we.



Almost word for word eh?

Pharma must think we are stupid... either that or they think they are untouchable.

The drug has already been licensed and is going through the approval process with the Government's drugs rationing watchdog.

It is expected to become widely available in Britain in the New Year.


God help us!


[1] Moser, Judith (2008-09-02). "Agomelatine Appears Superior to Sertraline for Treatment of Major Depressive Disorder: Presented at ECNP". DGDispatch (Doctor's Guide Publishing Limited). Retrieved 2009-05-14.

[2]
Int J Neuropsychopharmacol. 2007 Oct;10(5):575-8. Epub 2007 Aug 6. PMID: 17681087

[3] M. J. Millan, A. Gobert, F. Lejeune, A. Dekeyne, A. Newman-Tancredi, V. Pasteau, J.-M. Rivet & D. Cussac (September 2003). "The novel melatonin agonist agomelatine (S20098) is an antagonist at 5-hydroxytryptamine2C receptors, blockade of which enhances the activity of frontocortical dopaminergic and adrenergic pathways". The Journal of Pharmacology and Experimental Therapeutics 306 (3): 954–954. doi:
10.1124/jpet.103.051797. PMID 12750432.

Fid

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