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Re: FDA Finds Gepirone ER 'Not Approvable'

Posted by SLS on June 25, 2004, at 22:20:32

In reply to Re: FDA Finds Gepirone ER 'Not Approvable', posted by linkadge on June 25, 2004, at 10:00:18

> I wonder why. I would think that this drug would be potentially usefull. Kind of like a more potent one a day buspar.

As a monotherapeutic treatment for major depression, gepirone may not be any more effective than buspirone. Originally investigated as an antidepressant, buspirone did not offer sufficient efficacy to be pursued for the indication of depression. However, gepirone might represent a great add-on to standard antidepressants as an augmenting agent to enhance an otherwise inadequate therapeutic response. It might offer tolerability advantages compared to buspirone in that it lacks the effects that buspirone has on dopamine receptors. Partial agonists of 5-HT1a receptors might make valuable tools as augmentors to treat depression and anxiety disorders, but not as monotherapy.

Currently, I don't think there is much motivation on the part of drug manufacturers to pursue the development of agents that are to be used only occasionally to augment existing antidepressants in the same way that Lamictal, Neurontin, and Topamax were developed as add-ons to standard AEDs to be used only in treatment-resistant cases of epilepsy. Ritanserin, a uniquely selective 5-HT2 receptor antagonist, represents another useful drug that could be used in a variety of medical conditions, but that continues to be neglected because it is without a monotherapeutic indication. In my opinion, both gepirone and ritanserin should be added to our pharmacopeia. I doubt we'll see them as long as pharmaceutical research remains driven by the economics dictated by company stockholders.

- Scott




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