new phase III data confirms dutasteride is superior to finasteride

[woebehold]

Gsk have released new phase III data

Placebo -4.9 ± 7.89
0.02mg dut 17.1 ± 7.74
0.1mg dut 63.0 ± 7.67
0.5mg dut 89.6 ± 7.87
1mg fin - 56.5 ± 8.12

http://clinicaltrials.gov/ct2/show/study/NCT01231607?sect=X6015

[mrblazer]

so could this mean FDA approval for hairloss soon?

[PatientlyWaiting]

Good find.

Took them 3 years from October 2010 till now. The FDA is abusive.

I thought that it was well known since about more than 10 years ago that dutasteride was superior. I guess this will now make dutasteride more affordable and readily available for MPB? I'm not familiar with the FDA phases, but if I am not mistaken, now dutasteride can be sold n the U.S. for MPB? Or is there going to be a phase 3b, c, d, e, f, g, 4a, 4b, 4c, etc?

[PatientlyWaiting]

I'm looking through the results and I honestly have no idea what i'm reading with all the 2.3 cm, >=30 µm in width, 0.44 inches, blah blah. I wish there were pictures, lol, would make it much easier.

[Notcoolanymore]

If I don't get decent results from fin, then I will give dut a try. I will give fin at least a full year before jumping to dut as it is stronger.

And I agree that it would be nice to see pics. Clear pictures of results can be convincing.

[frankJ]

Gsk have released new phase III data

Placebo -4.9 ± 7.89
0.02mg dut 17.1 ± 7.74
0.1mg dut 63.0 ± 7.67
0.5mg dut 89.6 ± 7.87
1mg fin - 56.5 ± 8.12

http://clinicaltrials.gov/ct2/show/s...607?sect=X6015

Hey, I just wanted to make the correction that 1mg fin should read 56.5 ± 8.12.
Otherwise the placebo does a better job.

[crafter]

GSK are currently doing a 12 month phase 3 trial with results later next year, so it could be on the market in 2 years.

[woebehold]

I believe this is the last of the trials before application of the licence, and the only reason why I found this is because I knew this trial was ongoing, but they were late releasing the study results.

I'm guessing FDA asked GSK to redesign the trial, that's why we have two phase iii trials. Believe me, they are incredibly expensive to run, so GSK are clearly investing in licensing avodart for a new indication.

[JulioGP]

And the side effects are stronger than Fin, no away.

[macster]

Well the patent on Propecia has expired, so that treatment will be going fully generic shortly. Right now I think there is only 1 generic 1mg finasteride manufacturer. But soon others will enter the market, eviscerating the profit that can be made on Propecia.

So now, the market is ripe for a "new" drug to enter the market -- dutasteride.

It's the same thing Merck did with Proscar. It was on the market for about a decade as a prostate medication (as Avodart is now) before it was patented in the 1mg form for use for hair loss.

Likewise, GKS will probably adjust the dosage of dutasteride to something most ideal for hair loss and then change that name into something like Avodarticia or Avicia or something like that and sell this exclusively for hair loss for a good decade or so. Make lot$ of money.

Hopefully they don't make it too expensive.

[woebehold]

Well the patent on Propecia has expired, so that treatment will be going fully generic shortly. Right now I think there is only 1 generic 1mg finasteride manufacturer. But soon others will enter the market, eviscerating the profit that can be made on Propecia.

So now, the market is ripe for a "new" drug to enter the market -- dutasteride.

It's the same thing Merck did with Proscar. It was on the market for about a decade as a prostate medication (as Avodart is now) before it was patented in the 1mg form for use for hair loss.

Likewise, GKS will probably adjust the dosage of dutasteride to something most ideal for hair loss and then change that name into something like Avodarticia or Avicia or something like that and sell this exclusively for hair loss for a good decade or so. Make lot$ of money.

Hopefully they don't make it too expensive.

They will expect peanuts from it, if propecia revenue is anything to go by. Its currently taking in shy of $1bn in global sales...not quite a blockbuster ...but near enough...propecia takes in 150m, or there abouts.

They dnt have to adjust dosing under most patent laws for meds...just license it for alternative indications, and get about 5yrs extension

[macster]

Are Propecia revenues really that small? Wow, I'd have thought they would have been making lots more money, given that so many men are concerned about hair loss.

[burtandernie]

Two words Sexual sides. Not a lot of guys want a drug that can give sexual sides even if its small and its for hair. If not for the sexual sides I think propecia would have done much better, and keeping hair is not as impressive as regrowing a lot of hair.
I think hair loss has more money in it then propecia shows.

[25 going on 65]

Two words Sexual sides. Not a lot of guys want a drug that can give sexual sides even if its small and its for hair. If not for the sexual sides I think propecia would have done much better, and keeping hair is not as impressive as regrowing a lot of hair.
I think hair loss has more money in it then propecia shows.

Most balding men never learn about fin or dut.

[bibz]

Global Assessment of Improvement From Baseline to Week 24 Assessed for Frontal View : - DUT 0.5mg : 0.58
- FIN 1mg : 0.34

Change From Baseline in Investigator Photographic Assessment Questionnaire (IPAQ) Scores Assessed at Week 24 for Frontal View:
- DUT 0.5mg : 1.11
- FIN 1mg : 0.88

ADVERSE EVENTS:
Libido decreased: -DUT 0.5mg :3.26% -FIN 1mg :5.03% -Placebo :1.1%
Erectyle dysfunction:-DUT 0.5mg :5.43% -FIN 1mg :5.59% -Placebo :3.87%

-------------------------

Now please stop with the famous "dut hairline destroyer blabla myth" and "dut is like Satan, it can kills you and especially your d*ck"

Oh by the way Glaxo is going to start a long-term safety clinical for the sexual sides, everyone will see that dut isn't a monster : http://clinicaltrials.gov/ct2/show/N...+sexual&rank=1