avodart won't be released to market

[brian liles]

I just want to update you guys on avodart being released for hairloss. I recently contacted Glaxo and this is what they said.



Dear Mr. Brian Liles:

Thank you for contacting GlaxoSmithKline about AVODART® (dutasteride).

GSK will not be pursuing further studies on the use of dutasteride for Androgenetic Alopecia (alopecia - male pattern hair loss). This decision is based on market research analyses and not for any safety or efficacy reasons.

A copy of the prescribing information for this product is available at http://us.gsk.com/products/assets/us_avodart.pdf for review and discussion with an appropriate healthcare provider.

We appreciate the opportunity to serve you. If you have further questions concerning GlaxoSmithKline or our products, please contact our Response Center at 1-888-825-5249 during our normal business hours, Monday through Friday 8:00 A.M. to 6:00 P.M. (Eastern Time).

This is a send only email address. Please do not reply to this email.

Sincerely,



Anitra
Response Center Representative

 

[Bryan]

That's EXACTLY what I've been trying to tell people for years! Glaxo decided a long time ago not to pursue FDA approval of dutasteride for treating male pattern baldness.

 

[brian liles]

I don't understand why though. Everyone knows avodart is more potent at reducing DHT than finasteride, and they could make millions of dollars had they pursued an FDA approval. I guess they don't want more money lol.

 

[Bryan]

I don't understand why though. Everyone knows avodart is more potent at reducing DHT than finasteride, and they could make millions of dollars had they pursued an FDA approval. I guess they don't want more money lol.

I'm not sure about the economics of such a decision. They might make a few millions of dollars for having it be approved for fighting male pattern baldness, but it would also cost them a lot of money (more millions of dollars) to have it be approved for that purpose. I think the executives at Glaxo decided it would be a push.

 

[Chris87]

From what I've read, even Propecia, for Merck..is not considered a huge drug as far as profits (I read a number of something like 400 million a year..which i guess to them isn't much). Maybe its not worth it to them to go through the trouble to market, repackage, get approval etc because 1. they'll have to compete with the brand name propecia 2. the user base will probably be much smaller than that of propecia due to it being a more "extreme" treatment. 3. they know that people who need something as powerful as dutasteride have probably already looked it up on their own and are using it anyway 4. there are other treatments that are looking really promising right now that would blow anti androgens out of the water if they're successful. It might take years to get avodart approved for hair loss, do all the necessary marketing and preparation..only to have it be blindsided by a new treatment that makes all that work almost useless

 

[abcdefg]

I think it would be stupid for them to get this approved too. Avodart has sides equal to or worse then propecia and yes it might work better, but is it that much of an improvement over propecia? I would argue no and combine that with the few other potential male pattern baldness treatments coming like CB, ascj 9, or others and its just not worth it financially. I think CB or ascj 9 by going topical and targeting receptors will be a much safer and more effective approach then taking avodart so why compete against a better product. Assuming of course those other treatments ever pan out. Not to mention that PGD 2 research among others and the market is too crowded for avodart to do much anyways.

 

[Wuffer]

I'm not the least bit surprised. As was mentioned, Propecia was a relative failure in the market. Especially considering the controversy of 5ARI's currently circulating in the media, and the fact that there already exists a very similar treatment, I couldn't imagine GSK taking the time and money to get dutasteride approved. I don't know how many millions of dollars it costs to push a drug through the FDA approval process and not to mention the money they will need to spend on marketing, but I don't blame them for not wanting to do this.

Pharmaceutical companies are great at finding out how to make money. You can rest assured they did their due diligence to see if this venture would be profitable. Apparently it isn't! But hey, at least everyone can still get it off-label!

 

[abcdefg]

True. I think there will always be a place for anti androgens with how well they work and even the guy that found the pgd 2 discovery said the future will just be treatment from many angles and anti androgen will always be an important angle. Hopefully we get a stronger safer form but still.

 

[Bryan]

By the way, dutasteride isn't an "antiandrogen". Neither is finasteride. Let's try to keep that straight.

 

[pidda]

lol someday I'd probably be dumb enough to start taking dutasteride anyway

 

[Chris87]

By the way, dutasteride isn't an "antiandrogen". Neither is finasteride. Let's try to keep that straight.

What would it technically be called? An enzyme inhibitor? That would make sense, although i would think you can still describe its net effect as being anti-androgenic

 

[Bryan]

By the way, dutasteride isn't an "antiandrogen". Neither is finasteride. Let's try to keep that straight.

What would it technically be called? An enzyme inhibitor? That would make sense, although i would think you can still describe its net effect as being anti-androgenic

It's called a "5a-reductase inhibitor". It's not an "antiandrogen", because it doesn't bind to androgen receptors.

 

[JWM]

By the way, dutasteride isn't an "antiandrogen". Neither is finasteride. Let's try to keep that straight.

What would it technically be called? An enzyme inhibitor? That would make sense, although i would think you can still describe its net effect as being anti-androgenic

It's called a "5a-reductase inhibitor". It's not an "antiandrogen", because it doesn't bind to androgen receptors.

You might want to add something like this to your signature, Bryan.

 

[Bryan]

You might want to add something like this to your signature, Bryan.

Good idea! I've thought about adding things to it lately, but I'm unsure what the maximum size of the "signature" is. Of course, I can always compensate for that a little, by REMOVING the one in the middle (the one about Retin-A and minoxidil), which has probably outgrown its usefullness by now.

I'm considering changing that middle one to either of the following:

2) "Proxiphen is the Rolls Royce of hairloss treatments" -- Will Brink

or

2) Finasteride and dutasteride aren't "antiandrogens", because they don't bind to androgen receptors.

Anybody have any preference?

 

[Chris87]

I suppose this section is mislabeled on the forum then, as 90% of the discussion revolves around finasteride and dutasteride

 

[Bryan]

I suppose this section is mislabeled on the forum then, as 90% of the discussion revolves around finasteride and dutasteride

I don't even like the name "Antiandrogens & Androgen Blockers", because the "Androgen Blocker" part of it is confusing and uncertain. This is why I say to people over and over: please please PLEASE, use the same terminology that doctors use in medical journal studies and articles! It'll eliminate a great deal of confusion!! :shock:

 

[JWM]

You might want to add something like this to your signature, Bryan.

Good idea! I've thought about adding things to it lately, but I'm unsure what the maximum size of the "signature" is. Of course, I can always compensate for that a little, by REMOVING the one in the middle (the one about Retin-A and minoxidil), which has probably outgrown its usefullness by now.

I'm considering changing that middle one to either of the following:

2) "Proxiphen is the Rolls Royce of hairloss treatments" -- Will Brink

or

2) Finasteride and dutasteride aren't "antiandrogens", because they don't bind to androgen receptors.

Anybody have any preference?

I'd go with the second one about finasteride and dutasteride. You know as well as I that the first one about Proxiphen would start too many wars...or provide fuel to the many existing ones

 

[otis]

I think its only for the USA. They took the study to Korea as far as i no and it just might be aproved in europe. What you guys think