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Re: Agomelatine Approval .. Who's with me ?

Posted by Nadezda on September 24, 2008, at 16:59:02

In reply to Re: Agomelatine Approval .. Who's with me ? Nadezda, posted by Marty on September 24, 2008, at 16:01:06

I agree new ADs should be fast-tracked if they're safe and at least somewhat effective. I guess I'd like to see some showing of effectiveness, because there are often unanticipated SEs and also just going through many drugs trials is a cost for people. But definitely if they're as effective-- I don't see the reason to insist they be more effective, for all the reasons you state. There are way too many people for whom no AD works, or even if it reduces symptoms, doesn't really work as much as one would want-- not to mention drugs that work for a while and lose efficacy.

So, yes, I agree new types of ADs are especially important.

My pdoc told me one time that it's far more difficult to get an AD approved than a drug for cancer or heart disease-- and the SEs have to be almost negligible, because depression and other mood disorders aren't taken seriously. On one level, I see their point-- but they underestimate the devastating impace of suffering from depression.

Also, a lot of drugs for depression are found only because they're used for something else-- and it's seen that a SE is that people with the disorder do better emotionally.

Do you think a petition would really make any difference with the FDA or EMEA?





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