Dutasteride Clinical Trials - Phase III (Korea)

[paximperia]

Is this study ever going to be finished? It was started in Dec '06, and was supposed to go on for 6 months. Anyone have info on this?

http://clinicaltrials.gov/ct/show/NCT00 ... A?order=13

By the way, I've always wondered why the FDA Phase III hair loss trials for Dutasteride were canceled. It could be lack of expected profit, because I think Dutasteride is scheduled to become generic in the USA quite soon, but then why redo the trials in Korea after investing all that money in starting up the US trials? Also, surely they must have known that it was going to go generic and made that decision BEFORE starting the Phase III trials. Whatever made them decide to cancel the trials, I'm betting it was because of something that happened during the trials.

Could it be because it makes body hair [possibly] fall out, and Koreans don't have much to start with? I'd imagine that could be considered an unwanted side-effect for some people in the US. I wouldn't mind losing a little, but I wouldn't want to lose my armpit hair, or all of my hair "down there" if you know what I mean. : )

 

[paximperia]

Also I read by several people here that Dutasteride has reduced body hair. Anyone that lost hair in those "special places"? Seeing that Dutasteride stays in your blood for so long, I don't want to walk around looking like a 5 year old for six months.

 

[Guest]

yeah because women really hate guys with no body hair. they just hate that. they prefer hairy beasts. i don't think you have anything to worry about paximperia, your status as a bear will not change.

 

[paximperia]

lol. Most women I know don't like a 12 year old's genitalia either. Propecia has thinned my body hair significantly thou.

 

[Pondle]

By the way, I've always wondered why the FDA Phase III hair loss trials for Dutasteride were canceled. It could be lack of expected profit, because I think Dutasteride is scheduled to become generic in the USA quite soon

I thought the dutasteride patent still had quite a few years before it expires? Besides, if it was closer to expiry, that might motivate GSK to seek a licence for a new indication, in order to extend the life of the drug in its product portfolio. That seems to be the standard patent protection strategy for Big Pharma these days.

 

[paximperia]

Would finding a new indication allow them to extend their patent? I always thought that patents protect drugs for 17 years from the date of filing (regardless of the use). Finasteride went generic 17 years after the patent filing for the chemical, but well before 17 years after Propecia was approved.

 

[paximperia]

Actually they can file for an extension for the time the drug spent in FDA trials. There's some other information regarding extensions, but I'm too lazy to read it. : )
http://www.ladas.com/Patents/Biotechnol ... har32.html

 

[Pondle]

Would finding a new indication allow them to extend their patent? I always thought that patents protect drugs for 17 years from the date of filing (regardless of the use). Finasteride went generic 17 years after the patent filing for the chemical, but well before 17 years after Propecia was approved.

Proscar has gone generic, but Propecia hasn't.

 

[paximperia]

Propecia has gone generic, but the drug stores won't start carrying it until the competition starts carrying the generics. Drug stores have no motivation to carry the generics right away, because the profit margin on the brand names is higher.

http://answers.google.com/answers/threadview?id=594304

 

[Pondle]

I think that's wrong - patents on 1mg finasteride (i.e. Propecia) expire in 2013 according to the FDA. Which sounds right to me, because otherwise drug companies would have no incentive to pursue new indications/dosages if they didn't extend the patent on the original compound in some form.

http://www.accessdata.fda.gov/scripts/c ... ble1=OB_Rx

When the patent does expire, Merck will presumably cease to manufacture Propecia. It seems to have ceased to manufacture Proscar, judging by the proscar.com website.

 

[paximperia]

According to this website, generic Dutaseride won't be available until 2013, and patents can be extended for different uses of the drug.

http://men.emedtv.com/dutasteride/gener ... eride.html

...Dido.

 

[Pondle]

I wonder if GSK will seek to licence a new dose for hairloss as 2013 approaches (on the assumption that no other breakthrough meds appear in the mean-time)?

 

[paximperia]

In fact, if that is the case, it would explain why they are taking so long. If I was a drug company selling Avodart, I would rather have doctors prescribe it off the label for hair loss for 17 years, and (as you said) file for an extension as the expiration approaches by getting it approved for hair loss (and getting another 17 years of exclusive use, maybe?).

 

[Old Baldy]

I was WRONG on the finasteride patent expiring for all uses. The 1mg, Propecia patent, even though it is a method patent, apparently prevents anyone from making a 1mg generic pill!

Bryan and all you guys were correct! Unbelievably stupid rule. However, Merck did pay for the finasteride testing.

From a "pharmaceutical" site:

To extend the profit horizons of their drugs even further, pharmaceutical firms may even find new uses for their drugs while their patents are still active. This practice often results in multiple patents awarded to a company for the exact same drug, but whose uses differ on the basis of the medical treatments the drug manufacturer has claimed that the drug can treat. For example, Merck used the results of its clinical trials on its prostrate drug Proscar to justify to the FDA its use in hair-loss management in men under the new name Propecia. Differing only by their different uses, Proscar and Propecia are essentially the same drug, yet have been awarded separate patents and consequently more years of drug protection for Merck [4]. Similarly, the firm Eli Lilly also found a new use for its antidepressant drug Prozac, whose new name is Sarafem, now a treatment for Premenstrual Dysphoric Disorder (PMDD), extreme cases of Premenstrual Syndrome (PMS) [4].