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

Posted by McPac on June 19, 2003, at 2:27:41

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):

Clinical efficacy of reboxetine
in major depression

Schatzberg AF

Department of Psychiatry and Behavioral Sciences,
Stanford University School of Medicine,
Calif 94305-5717, USA.
J Clin Psychiatry 2000; 61 Suppl 10:31-8

ABSTRACT

The past decade has witnessed the advent of selective serotonin reuptake inhibitors (SSRIs) as first-line treatments for major depression. Still, there is considerable debate as to whether these agents are as effective or as potent as the first-generation tricyclic antidepressants (TCAs) or the mixed reuptake inhibitor, venlafaxine, all of which exert considerable effect on norepinephrine (NE) reuptake. Recently, reboxetine, a selective NE reuptake inhibitor (selective NRI), has been introduced in Europe. This drug has only a minimal affinity for muscarinic acetylcholine receptors and therefore causes less dry mouth, constipation, or other such effects than do the TCAs. Reboxetine does not block serotonin reuptake or alpha1 receptors and, thus, does not appear to produce significant nausea, diarrhea, or hypotension. Unlike other antidepressants, reboxetine appears to be nonsedating. Data on acute and long-term clinical efficacy and safety from double-blind, placebo-controlled, and active comparator studies with reboxetine are reviewed. These studies indicate that reboxetine is significantly more effective than placebo and as effective as fluoxetine in reducing depressive symptoms. Improvements in social adjustments were reported to be more favorable with reboxetine than with fluoxetine. Further, data from controlled clinical trials have shown that the side effect profile for reboxetine is relatively benign. The clinical implications of studies on reboxetine are discussed with an eye toward understanding the potential role NE reuptake blockers may play in the treatment of patients with major depression.


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poster:McPac thread:235009
URL: http://www.dr-bob.org/babble/20030614/msgs/235009.html