Outlook for Dut/ Avodart approval for MPB

[Dav7]

I'm just wondering if anybody knows if there are actual trials going on regarding Dutasteride's usage for MPB? I am not too sure, but I think that I heard before somewhere that it could be, but I'm not too sure if my memory serves me correctly. It would certainly be an interesting development given how much DHT it blocks in comparison to even Finasteride.

[hsrp10]

not sure of the trials, but I know some HT doctors do prescribe it

the sides seem much stronger than with Fin so you have to be careful with DUT (I'm not on it yet)

[GoForIt]

My thought is there is little to no chance that the company will go for the indication in the US.

 

Finasteride is generic and has the approval. While the trials show dutasteride is somewhat better, it isn't a slam-dunk.

 

If I were the CEO of the company making dutasteride, I would look closely at the experience with finasteride. The company didn't make much money off it for the MPB indication, and now has the headache of dealing with complaints about side-effects. A three month supply of generic finasteride (5mg tabs, cut into fourths) costs between $15-$30 depending on where you buy it. This is what dutasteride would have to deal with economically.

 

As the CEO, I would not invest the millions (probably tens of millions of dollars) it would take to get FDA approval for that indication, but rely on the fact that patients would request it and physicians would prescribe it for the off-label indication. The company would also have no liability for any side effects if the drug were prescribed off-label.

 

Long story short, there is no economic incentive for the company to do this. They've done some trials hinting it may be a little better than finasteride, the drug is on the market, and physicians can write a prescription for what ever indication they want.

[Rootz]

It is proven to be more effective than Fin in regards to blocking DHT. But that isn't necessarily a good thing. As you block closer and closer to 100% DHT side effects seem to become more real.

[Spanker]

My thought is there is little to no chance that the company will go for the indication in the US.

 

Finasteride is generic and has the approval. While the trials show dutasteride is somewhat better, it isn't a slam-dunk.

 

If I were the CEO of the company making dutasteride, I would look closely at the experience with finasteride. The company didn't make much money off it for the MPB indication, and now has the headache of dealing with complaints about side-effects. A three month supply of generic finasteride (5mg tabs, cut into fourths) costs between $15-$30 depending on where you buy it. This is what dutasteride would have to deal with economically.

 

As the CEO, I would not invest the millions (probably tens of millions of dollars) it would take to get FDA approval for that indication, but rely on the fact that patients would request it and physicians would prescribe it for the off-label indication. The company would also have no liability for any side effects if the drug were prescribed off-label.

 

Long story short, there is no economic incentive for the company to do this. They've done some trials hinting it may be a little better than finasteride, the drug is on the market, and physicians can write a prescription for what ever indication they want.

 

 

I agree with this. It is very common for many different meds to be prescribed for off label use. I don't see that they have too much to gain from it.