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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 5 of 5. This is the beginning of the thread.
Posted by 3 Beer Effect on June 4, 2002, at 0:03:03
I thought a whole bunch of new generation anxiolytics were in the pipeline/ going to be approved by the FDA? Where are they?
1. Partial Benzodiazpine Agonists?
When are the partial benzodiazpine agonists such as alpidem, abecarnil, bretazenil, or others going to be released, or if not what happened to them?2. New Serotonin 5HT-1A Agonists?
Where are the new Serotonin 5HT1-A agonists that are supposed to replace the largely dissapointing med Buspar?- such as Gepirone ER, Tandospirone, Flesinoxan?(Found this written year 2000 (2 yrs ago)- "Gepirone ER, a chemical cousin of Buspar is continuing in clinical development in the United States & Tandospirone in Japan."
"Ipsaspirone, Sunepitron, Transdermal Buspar & others have been dropped from clinical development, although there may be some continuting interest in Flesinoxan or others."3. Dual Serotonin & Dopamine Reuputake Inhibitors such as Minaprine & Bazinaprine?
Also written in year 2000 "Dual reuptake blocker of both serotonin & dopamine are in clinical testing. Although the SSRI Zoloft has some dopamine reuputake inhibition as well as more potent serotonin reuputake inhibition, Minaprine & Bazinaprine have more potent dopamine actions & are thus dual serotonin/dopamine agonists."3 Beers...........
Source of quotes, "Stahl, Stephen M., Essential Psychopharmacology of Depression and Bipolar Disorder (2000)".
Posted by JohnX2 on June 4, 2002, at 0:09:39
In reply to What happened to the new generation anxiolytics?, posted by 3 Beer Effect on June 4, 2002, at 0:03:03
Posted by JohnX2 on June 4, 2002, at 0:17:10
In reply to What happened to the new generation anxiolytics?, posted by 3 Beer Effect on June 4, 2002, at 0:03:03
Posted by Sparkboy on June 5, 2002, at 0:56:23
In reply to What happened to the new generation anxiolytics?, posted by 3 Beer Effect on June 4, 2002, at 0:03:03
> 2. New Serotonin 5HT-1A Agonists?
> Where are the new Serotonin 5HT1-A agonists that are supposed to replace the largely dissapointing med Buspar?- such as Gepirone ER, Tandospirone, Flesinoxan?
>
> (Found this written year 2000 (2 yrs ago)- "Gepirone ER, a chemical cousin of Buspar is continuing in clinical development in the United States & Tandospirone in Japan."
> "Ipsaspirone, Sunepitron, Transdermal Buspar & others have been dropped from clinical development, although there may be some continuting interest in Flesinoxan or others."
>>I thought a whole bunch of new generation anxiolytics were in the pipeline/ going to be approved by the
> FDA?Hello, 3 Beer. I started to say this question answers itself; look no further than the 3 letter government acronym. But that'd sound full of bitterness and misdirected hostility. Instead, I'll show you what Google spit out for me yesterday. Gepirone is especially promising for atypical depression, my own interest. I wonder if it's available in Europe.
Take it easy.
--JohnPS: gepirone has been bouncing around in research since ~1985. You'd think if it were dangerous, they'd know that by now.
Thursday April 11, 9:33 am Eastern TimePress Release
SOURCE: Akzo Nobel
Organon to consult with FDA on Ariza -gepirone ER-
ARNHEM/OSS, The Netherlands--(BUSINESS WIRE)--April 11, 2002--Akzo Nobel (NASDAQ:AKZOY - news), the multinational healthcare, coatings and chemicals company, today announced Akzo Nobel's business unit Organon has received a letter from the U.S. Food and Drug Administration (FDA) regarding the company's New Drug Application (NDA) for marketing authorization of gepirone ER tablets (also known as Ariza).
The letter mentions issues that will have to be addressed before the product can be approved. Organon has already contacted the FDA about providing additional information or clarification as necessary.
Organon has confidence in the NDA it submitted in May 2001, and trusts in its ability to satisfactorily address the issues presented in the letter. However, approval of the product is dependent upon the outcome of consultation with the FDA. It is not possible to provide more information with regard to marketing authorization until after receipt of further response from the FDA. It is expected, however, that contrary to previous announcements the product will not be introduced in 2002.
Ariza is a new drug for the treatment of patients with major depressive disorders.
Posted by jrbecker on August 21, 2002, at 15:24:11
In reply to What happened to the new generation anxiolytics?, posted by 3 Beer Effect on June 4, 2002, at 0:03:03
is going ahead. New drug application submitted in 4/01. Is online to hopefully reach market around mid-2003.
This is the end of the thread.
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