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Re: Reboxetine (not approved in U.S.? FDA blows!)

Posted by Snoozy on June 19, 2003, at 10:58:28

In reply to Reboxetine (not approved in U.S.? FDA blows!), posted by McPac on June 19, 2003, at 2:27:41

Ugghh - tell me about it! I have had this article from Time magazine (Time - can you get a more mainstream publication than that?) from September 1997 on depression and neurotransmitters.

"Already psychiatrists are buzzing with news of reboxetine, which totally ignores serotonin and goes after norepinephrine, the neurotransmitter Prozac left behind. Approved in England just this past summer, it works quickly, has relatively mild side effects (constipation, dry mouth, low blood pressure) and might eventually be the therapy of choice for people with especially severe depression."

I had the impression that it would be on the market soon after I read this article, and I've been waiting. Looks like I'll be waiting a looong time. It's different from what's already on the market, not just a variation on the same-old, same-old. I had hope it might help me as I have not had good results with SSRI's. (The area pdoc that does nothing but drug research studies was doing a test of reboxetine in 1998-99, but I couldn't get in). Maybe it wouldn't do anything for me, but I'd like the chance to find out.

I would really love to know what the story is - is it opposition from other drug companies or what? It doesn't seem like the FDA has been overly cautious of late and it sounds like a pretty safe drug. Makes one wonder. I don't get this 'let's spend millions of dollars to get FDA approval to market Paxil or Zoloft for this condition'. My understanding of that is that they're simply going through hoops so they can put out ads on tv and in print and say 'this drug is a treatment for social anxiety disorder' or what have you. I heard something about Paxil trying to get approval to market it for hot flashes. Is it me or does something seem wrong with this situation?

Of course, it probably won't be long before all of the big drug companies merge into one entity. Then they can advertise with the one media conglomerate we'll have :)


> Been reading a lot about Reboxetine. Sounds VERY good. I suppose THAT is the reason that the pharmaceutical company-controlled FDA declined it's U.S. approval (I read that NO reason was given why).....puleeeeeze! translation, it wasn't approved because many ssri patients would have switched! These pharm. co's will protect their turf and do whatever they can to keep better drugs being approved. Everything I read, in many abstracts, point to Reboxetine being at least as good and even better for severe depression and having much less side effects than ssri's like Prozac. Block the better drug from approval and keep this crummy ssri monopoly going, what a joke. (1 abstract below; read MANY that were similar):
>


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poster:Snoozy thread:235009
URL: http://www.dr-bob.org/babble/20030619/msgs/235069.html