Psycho-Babble Medication Thread 360155

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FDA Finds Gepirone ER 'Not Approvable'

Posted by jrbecker on June 25, 2004, at 8:16:51

oh well...

http://home.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20040624005654&newsLang=en

June 24, 2004 07:53 PM US Eastern Timezone

FDA Finds Gepirone ER 'Not Approvable' as a Treatment for Major Depressive Disorder

ARNHEM, Netherlands--(BUSINESS WIRE)--June 24, 2004--The U.S. Food and Drug Administration has determined that Organon's gepirone ER New Drug Application is "not approvable."


This action is the FDA's response to an amendment to Organon's New Drug Application submitted to the FDA in December 2003. Organon plans to withdraw the application for gepirone as a treatment for major depressive disorder.

"Organon is disappointed in this response from the FDA and we are moving forward with our next steps in the development of products for mental health," said Toon Wilderbeek, Organon International President and Akzo Nobel Board Member.

Note for the editor

Akzo Nobel, based in the Netherlands, serves customers throughout the world with healthcare products, coatings and chemicals. Consolidated sales for 2003 totaled EUR 13 billion. The Company currently employs approximately 64,300 people in more than 80 countries. Financial results for the second quarter will be published on July 19, 2004.

Organon, headquartered in Roseland, NJ, USA creates and markets prescription medicines that improve the health and quality of human life. Through a combination of independent growth and business partnerships, Organon strives to become or remain one of the leading pharmaceutical companies in each of its core therapeutic fields: reproductive medicine, psychiatry and anesthesia. Organon products are sold in over 100 countries, of which more than 60 have an Organon subsidiary.

Organon is the human health care business unit of Akzo Nobel.

Internet: www.akzonobel.com; www.organon.com

Not for publication - for more information

Organon Pharmaceuticals USA Inc. - Fran DeSena, Phone +1 973 325 5353

Safe Harbor Statement*

This press release may contain statements which address such key issues as Akzo Nobel's growth strategy, future financial results, market positions, product development, pharmaceutical products in the pipeline, and product approvals. Such statements should be carefully considered and it should be understood that many factors could cause forecasted and actual results to differ from these statements. These factors include, but are not limited to, price fluctuations, currency fluctuations, developments in raw material and personnel costs, pensions, physical and environmental risks, legal issues, and legislative, fiscal, and other regulatory measures. Stated competitive positions are based on management estimates supported by information provided by specialized external agencies. For a more complete discussion of the risk factors affecting our business please refer to our Annual Report on Form 20-F filed with the United States Securities and Exchange Commission. A copy of which can be found on the Company's website.

-- Pursuant to the U.S. Private Securities Litigation Reform Act 1995.

 

Re: FDA Finds Gepirone ER 'Not Approvable'

Posted by linkadge on June 25, 2004, at 10:00:18

In reply to FDA Finds Gepirone ER 'Not Approvable', posted by jrbecker on June 25, 2004, at 8:16:51

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


Linkadge

 

The FDA is Hurting Consumers

Posted by Shawn. T. on June 25, 2004, at 11:58:11

In reply to FDA Finds Gepirone ER 'Not Approvable', posted by jrbecker on June 25, 2004, at 8:16:51

I find that decision nothing less than infuriating; the FDA had better have a very good reason for their ruling. In the past few years, the FDA has consistently demonstrated a lack of disregard for the best interests for consumers. Their frequent conflicts of interests and inappropriate actions have been reported by USA Today ( http://www.mercola.com/2000/oct/1/fda_drug_approvals.htm ), the San Francisco Chronicle ( http://www.namiscc.org/News/2004/Spring/SSRI-Suicide.htm ), the Washington Post ( http://www.washingtonpost.com/ac2/wp-dyn/A58130-2004Jan28?language=printer ), Lancet ( http://www.mercola.com/fcgi/pf/2001/may/30/drug_industry.htm ), and several other news agencies. Given the FDA's troubled past, I find it difficult to accept that the FDA has based this decision on solid evidence. I'm unaware of any published findings that question the safety of gepirone; perhaps the drug's problem lies with the fact that its producer doesn't benefit from the same coziness that some other drug companies share with the FDA. Perhaps anti-consumer attitudes aren't quite as unethical in other government agencies, but the FDA has a very important responsibility to follow reasonable ethical standards. When lives are stake, the FDA must now be allowed to exist as a servant of certain sectors of the pharmaceutical industry.

Shawn

 

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

 

Re: FDA Finds Gepirone ER 'Not Approvable'

Posted by SLS on June 26, 2004, at 6:09:39

In reply to Re: FDA Finds Gepirone ER 'Not Approvable', posted by SLS on June 25, 2004, at 22:20:32

I neglected to mention that buspirone and gepirone are both metabolized to form 1-PP (1-(2-pyrimidinyl)-piperazine). 1-PP is a NE alpha-2 receptor antagonist like Remeron, only without the potent antihistaminic properties of Remeron. This is yet another rationale for the use of these drugs as augmentors of antidepressants.


- Scott

 

Re: FDA Finds Gepirone ER 'Not Approvable' SLS

Posted by jrbecker on June 27, 2004, at 12:43:04

In reply to Re: FDA Finds Gepirone ER 'Not Approvable', posted by SLS on June 25, 2004, at 22:20:32

> > 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

I would agree Scott. 5HT1A partial agonists, on their own, would not make robust ADs, while they do have the potential to be great add-ons, especially for an atypical depressive. Here are some possible reasons why...

-the 5HT1a receptor in the hippocampus is believed to be responsible for neurogensis.
-5HT1a directly affects ACTH and thus cortisol, modulating the HPA response.
-5HT1a affects the circadian cycle by having a direct stimulating the suprachiasmatic nucleus (SCN).
-the metabolite, an alpha-2 antagonist, also has antidepressant effects of its own. This receptor is thought to be responsible for the AD effect in drugs such as remeron, paxil and dhea. however, I also believe that this might be the source of irritability and labile mood in some individuals).
-5HT1a agonists are pro-sexual, increasing both libido and ability.

Other companies have tested 5HT1a partial agonists before, though most failed to show robust phase III trials.

A couple compounds are in early phase clinical trials, including one that is also a sigma-agonist and SSRI at higher dosages.

JRB

 

Re: FDA Finds Gepirone ER 'Not Approvable' jrbecker

Posted by SLS on June 27, 2004, at 17:43:39

In reply to Re: FDA Finds Gepirone ER 'Not Approvable' SLS, posted by jrbecker on June 27, 2004, at 12:43:04

Thank you.

:-)


- Scott

 

Re: FDA Finds Gepirone ER 'Not Approvable'

Posted by zeugma on June 27, 2004, at 21:57:27

In reply to Re: FDA Finds Gepirone ER 'Not Approvable' SLS, posted by jrbecker on June 27, 2004, at 12:43:04

We see what is happening now with nefazodone- people who need this drug because nothing else helped are scared to death that it will vanish completely from the market. Gepirone in my opinion would help an equal if not greater amount of people, plus as everyone has said it is a great add-on, would counteract a lot of SSRI side effects for many people, and is one of the safest drugs out there. The FDA is behaving in a very misguided way.

 

Re: FDA Finds Gepirone ER 'Not Approvable'

Posted by jrbecker on June 28, 2004, at 14:18:40

In reply to Re: FDA Finds Gepirone ER 'Not Approvable', posted by zeugma on June 27, 2004, at 21:57:27

here's what one researcher involved in the study had to say in reaction to the fda's decision...


"Too bad.

I wonder what their reasoning was. Of course they do not say, but this is one I think they made a mistake on, or else there is something I do not understand here..."

Jonathan W. Stewart, M.D.
Depression Evaluation Service
New York Psychiatric Institute
Columbia University


 

Re: FDA Finds Gepirone ER 'Not Approvable'

Posted by Cecilia on June 29, 2004, at 1:54:24

In reply to Re: FDA Finds Gepirone ER 'Not Approvable', posted by jrbecker on June 28, 2004, at 14:18:40

Does this mean it`s out of the running completely or just that they need to do more studies? Surely they have to give some sort of explanation. Frankly, I don`t understand how medical research works. I`m still totally confused by why we can`t have stem cell research because Dubya doesn`t want it-there`s certainly nothing in the constitution giving the president authority over medical research. Cecilia


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