21 Years Of Finasteride/ Dutasteride ( Since 1998, Duta Since 2002).

jamesbooker1975

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I think the reason it wasn't approved in the USA was purely profits. It makes complete since why they wouldn't continue to pursue approval here. No way they're making a decent profit on it. Too many people already having good success on finasteride. Why would they switch over to dutasteride if finasteride is already working, and the side effects are more likely on duta? Also when propecia was approved for hair loss there was no generic available. There is generic dutasteride already available for BPH, and most US doctors are willing to prescribe off-label if it is already approved for hair loss as well, so GSK would make absolute sh*t off this in the USA.

Why , REALLY !? Cause this dude :
Screen-Shot-2014-12-03-at-10.21.12-PM.png
 

jamesbooker1975

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Based off phase III results for Japan, it is more risky than finasteride. Higher incidence of sexual side effects. Also, personally don't like the long half-life, especially given the higher incidence of side effects, because if you do get side effects and quit it will stay in your system for a while.
Please post the link where we can read it. I guess you are telling "Higher incidence of sexual side effects" . Also, it was not done in Japan, it was done on South Korean, I know that for an ignorant person both countries are the same, but is like Say that UK and USA are the same.
 

dralex

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Why , REALLY !? Cause this dude :
View attachment 62023
What? What is this supposed to prove?
Please post the link where we can read it. I guess you are telling "Higher incidence of sexual side effects" . Also, it was not done in Japan, it was done on South Korean, I know that for an ignorant person both countries are the same, but is like Say that UK and USA are the same.
Dumbass....was just approved in Japan. Approval process for Japan is more extensive. Was already approved in South Korea. Learn your sh*t before you spew random crap out your mouth. And I'll post it in a sec.
 

jamesbooker1975

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What? What is this supposed to prove?

Dumbass....was just approved in Japan. Approval process for Japan is more extensive. Was already approved in South Korea. Learn your sh*t before you spew random crap out your mouth. And I'll post it in a sec.
Keep insulting. POST THE DAMN LINK SHOWING !!!!!!!!!!!
 

jamesbooker1975

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What? What is this supposed to prove?

Dumbass....was just approved in Japan. Approval process for Japan is more extensive. Was already approved in South Korea. Learn your sh*t before you spew random crap out your mouth. And I'll post it in a sec.
You don't explain anything, you don´t answer questions an you insult. How long you thing it will happen before you get banned ?
 

dralex

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You don't explain anything, you don´t answer questions an you insult. How long you thing it will happen before you get banned ?
Wtf are you talking about? 2nd link is the Phase 3 Results in Japan.

You joined like 3 days ago...you're claiming to be a pharmacist with some expert knowledge on these drugs when you legit know like nothing and try to argue with everyone who disagrees with you.
 

dralex

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I'll stop with any name calling though...is unnecessary. Was just annoyed that you were claiming all this stuff as fact when it was just your opinions. I am sorry if these drugs actually fucked up your endocrine system. I do think AR inhibitors are risky and can cause side effects. I don't think they're safe for all people and it is difficult to determine if they're actually negatively impacting your body. Hair loss can be devastating as well though, so have to take some risks if you want results.

Also duta is definitely much riskier.
 

jamesbooker1975

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I'll stop with any name calling though...is unnecessary. Was just annoyed that you were claiming all this stuff as fact when it was just your opinions. I am sorry if these drugs actually fucked up your endocrine system. I do think AR inhibitors are risky and can cause side effects. I don't think they're safe for all people and it is difficult to determine if they're actually negatively impacting your body. Hair loss can be devastating as well though, so have to take some risks if you want results.
My opinion . Ok, first lets see the basic of the first link you passed me :
"
The effectiveness of finasteride and dutasteride used for 3 years in women with androgenetic alopecia."

WOMEN !!!!!! not males
Second, please post a link where it said that FDA, like you claimed, did not approve dutasteride cause side effects.
 

dralex

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My opinion . Ok, first lets see the basic of the first link you passed me :
"
The effectiveness of finasteride and dutasteride used for 3 years in women with androgenetic alopecia."

WOMEN !!!!!! not males
Second, please post a link where it said that FDA, like you claimed, did not approve dutasteride cause side effects.
What? Both these are male androgenic alopecia studies....It is the studies for approval in Japan.

First link says this:
Long-term safety and efficacy of dutasteride in the treatment of male patients with androgenetic alopecia.

And when did I say the FDA didn't approve dutasteride cause of side effects? I said the opposite. I said GSK didn't go through with phase III trials because they wouldn't have made a profit, and it had nothing to do with side effects.
 

jamesbooker1975

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Here's the studies. Sides are actually pretty high on duta studies...Why it worries me more than finasteride.

https://www.ncbi.nlm.nih.gov/pubmed/26893187
https://clinicaltrials.gov/ct2/show/results/NCT01831791
1) "As a potential future treatment option for male androgenetic alopecia, dutasteride 0.5 mg exhibited long-term safety, tolerability and efficacy within this study population."
2) It do not have result made public.

I really understand why you are keep posting here. You think that you can eliminate an hormone from the body without any side effects. Go for it, what can I tell you ? This is to post my personal experience like the tittle said.
Dutasteride, as also show you, was a lot more ( 40 % more hair ) than finasteride.
Check the profit of propecia : https://en.wikipedia.org/wiki/Annual_pharmaceutical_drug_sales
If you think this med don't have profit, I just hope you are not running any business cause you will fucked.
 

dralex

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1) "As a potential future treatment option for male androgenetic alopecia, dutasteride 0.5 mg exhibited long-term safety, tolerability and efficacy within this study population."
2) It do not have result made public.

I really understand why you are keep posting here. You think that you can eliminate an hormone from the body without any side effects. Go for it, what can I tell you ? This is to post my personal experience like the tittle said.
Dutasteride, as also show you, was a lot more ( 40 % more hair ) than finasteride.
Check the profit of propecia : https://en.wikipedia.org/wiki/Annual_pharmaceutical_drug_sales
If you think this med don't have profit, I just hope you are not running any business cause you will fucked.
That's sales...not profits. They have various expenses as well as incoming lawsuits. Sales were expected to be much higher than that in recent years, but are losing out on sales due to lawsuits, generics becoming available, and the scare of the drug now.

Dutasteride will not have sales even close to that. There is already generics available for BPH...who the hell would pay 20x more for the brand name when most doctors in the USA will prescribe off label. Doesn't matter if duta is more effective...whole point is, if you're having good results with fina, many doctors won't even prescribe duta as the side effects are much higher. Duta would be a second resort if fina isn't working, and even then you will probs get generics. Makes no sense to go through phase III trials which are time consuming and costly, if you're not making a profit.

The full phase III study results are made public....read the whole thing. Look at the side effects, they are insanely higher than the sides were on finasteride studies.
 

jamesbooker1975

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That's sales...not profits. They have various expenses as well as incoming lawsuits. Sales were expected to be much higher than that in recent years, but are losing out on sales due to lawsuits, generics becoming available, and the scare of the drug now.

Dutasteride will not have sales even close to that. There is already generics available for BPH...who the hell would pay 20x more for the brand name when most doctors in the USA will prescribe off label. Doesn't matter if duta is more effective...whole point is, if you're having good results with fina, many doctors won't even prescribe duta as the side effects are much higher. Duta would be a second resort if fina isn't working, and even then you will probs get generics. Makes no sense to go through phase III trials which are time consuming and costly, if you're not making a profit.

The full phase III study results are made public....read the whole thing. Look at the side effects, they are insanely higher than the sides were on finasteride studies.

You still no read the articles, we are talkign about 2002, there was not generics but that time . Second the maximun effects dose was seeing with 2.5mg daily, anyway it is a none sense talking to you cause you do not even read.
 

dralex

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You still no read the articles, we are talkign about 2002, there was not generics but that time . Second the maximun effects dose was seeing with 2.5mg daily, anyway it is a none sense talking to you cause you do not even read.
What articles lol? 2.5mg would be more effective but much higher sides. Don't know if many derms would prescribe it over finasteride, when finasteride is extremely effective for most.

This is a pretty accurate article on why I think GSK never went forward with Duta for hair loss.
https://www.hairlosstalk.com/news/editorials/truth-dutasteride-clinical-trials/
 
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abovedagame

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What are your thoughts on the psuedohermaphrodites from the Dominican Republic that merck scientists used as a model when developing finasteride. This population of men seem to never have issues being 5ar type 2 deficient
 

dralex

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What are your thoughts on the psuedohermaphrodites from the Dominican Republic that merck scientists used as a model when developing finasteride. This population of men seem to never have issues being 5ar type 2 deficient
Having a biological model is amazing for a drug, because we can see that if you are born 5ar type 2 deficient that it will have no long-term health effects. Issue is we cannot tell whether it will impact our sexual functions, because these men didn't sexually develop as men, and as we know 5ar type 2 is necessary for sexual development. Whether it is necessary post-development isn't completely known.

Also it may be different for someone who is born deficient in 5ar type 2 vs. someone who had it through development then randomly started blocking it. Still having a biological model offers more assurance on safety than not having one, which dutasteride does not.
 

abovedagame

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Having a biological model is amazing for a drug, because we can see that if you are born 5ar type 2 deficient that it will have no long-term health effects. Issue is we cannot tell whether it will impact our sexual functions, because these men didn't sexually develop as men, and as we know 5ar type 2 is necessary for sexual development. Whether it is necessary post-development isn't completely known.

Also it may be different for someone who is born deficient in 5ar type 2 vs. someone who had it through development then randomly started blocking it. Still having a biological model offers more assurance on safety than not having one, which dutasteride does not.

Thanks for the response but thus question was more geared towards the OP.

Just a small correction to what u said tho...
They did develop into men. After puberty their sexual organs developed more and their masculine features came out. They did however lack some of the things dht brings to us (facial hair, robust body hair, hair loss, etc)
 

Razzabo

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What are your thoughts on the psuedohermaphrodites from the Dominican Republic that merck scientists used as a model when developing finasteride. This population of men seem to never have issues being 5ar type 2 deficient

How do you know what issues they may or may not of had? My f*****g lord.. just take Merck's words for it..
 

Pequod

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In order to get FDA approval the safety profile of a drug is taken into account, a company cannot simply get approval for something if the FDA deems it to be unsafe.

And a drug being approved overseas does not guarantee it can be approved in the U.S.

They must have weighed the potential profits of dutasteride as dralex said, and since propecia did do relatively poorly they chose not to advance it since it would have been a competitor. i would guess they assumed it might command 15% of the Propecia market, and that is not enough for a large pharma company these days. Even small pharma would hesitate when you consider the costs and potential legal issues.

The last numbers I saw for propecia is $150 million per year now, 15% of that is only $22 million. That might not even cover a phase 3 trial, so I doubt it ever goes to phase 3. of coarse generics are out so it might be higher, but the generics today would also be competitors already. It seems dead on arrival now.
 

jamesbooker1975

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What are your thoughts on the psuedohermaphrodites from the Dominican Republic that merck scientists used as a model when developing finasteride. This population of men seem to never have issues being 5ar type 2 deficient
Well, let me ask you this :
1) what was they average Testosterone levels ?
2) what was they average estradiol levels ?
3) progesterone levels ?

etc etc etc. They told you, Hey they are men, even without 70 % of their DHT, and they are alive ! Sure, a men can also live without almost any testosterone. What about their libido ? are they more anxious then common people ? Are they aggressive when they have to do it ? etc , etc, etc
 
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