Great Great News!!!!

[studentdoc]

http://biz.yahoo.com/bw/060524/20060524005403.html?.v=1

[Vermillion]

that's pretty good news

i need my hands on some of dat pagoclone

[sruti]

thanks,that's really a great news.happy to know that reaserch is going on in this field.

[happy7117]

Anyone know when this stuff will be readily
available to take-- I mean when and if
it passes all the phases??

I mean has this been fully approved to take
as medicine for stuttering??

I wanted to participate in the study but the
doctor told me with that the medicine I already
take (Indreal), (Effexor), it may not be healthy...

My doctor and parents would like to see if this drug
Pagaclone will be fully safe before they agree to let me try it...

Would it be safe to take it with my curent medicine???

[studentdoc]

Anyone know when this stuff will be readily
available to take-- I mean when and if
it passes all the phases??

I mean has this been fully approved to take
as medicine for stuttering??

I wanted to participate in the study but the
doctor told me with that the medicine I already
take (Indreal), (Effexor), it may not be healthy...

My doctor and parents would like to see if this drug
Pagaclone will be fully safe before they agree to let me try it...

Would it be safe to take it with my curent medicine???

Hey there Happy... Phase II is done and successful so the company will meet with FDA and 99.99% continue to Phase III. This will require a larger population of participants and will usually take 1-2 years. At that time, they file a patent and release the medicine to the market. Realistically it will take another 3 years until all is said and done - unless they take a fast route which makes Phase III quicker but I think the FDA only allows that for drugs that are saving lives and have no comparable drugs on the market. We will see if they try anyway since it's the only drug approved. I think they will be annoucing openings for Phase III drugs since it requires a large sample pool so we should keep our eyes open for that. You can focus on drug interactions with your current drug if and when it gets released. On the brighter side, if for any reason Pagaclone is not approved for stuttering, it may still be approved for premature which is just starting its studies now. I have hope that we'll have this out soon!!! Hopefully much sooner than 3-4 years because I have to start giving daily presentations in a year from now in the hospitals!!! :D

[happy7117]

Hey there Happy... Phase II is done and successful so the company will meet with FDA and 99.99% continue to Phase III. This will require a larger population of participants and will usually take 1-2 years. At that time, they file a patent and release the medicine to the market. Realistically it will take another 3 years until all is said and done - unless they take a fast route which makes Phase III quicker but I think the FDA only allows that for drugs that are saving lives and have no comparable drugs on the market. We will see if they try anyway since it's the only drug approved. I think they will be annoucing openings for Phase III drugs since it requires a large sample pool so we should keep our eyes open for that. You can focus on drug interactions with your current drug if and when it gets released. On the brighter side, if for any reason Pagaclone is not approved for stuttering, it may still be approved for premature which is just starting its studies now. I have hope that we'll have this out soon!!! Hopefully much sooner than 3-4 years because I have to start giving daily presentations in a year from now in the hospitals!!! :D

3 year seems like an awfly long time to wait!!
Hey as long as it takes I will wait!!

[studentdoc]

3 year seems like an awfly long time to wait!!
Hey as long as it takes I will wait!!
By the way, it is in Phase III that they test for interactions with other drugs. And Phase III has 1,000 - 4,000 participants as opposed to the 100-300 in Phase II so we should all try and sign up for studies (given you don't take other drugs and are open to testing). As for me, I will do anything to get my hands on this before it is released. I know for Phase II, they were offering the drug free for 1 year after the study if it was approved but I didn't stutter "enough" on the video to be approved for the study.

[studentdoc]

Update: Indevius has updated their page today with information to sign up for Phase III study. PLEASE sign up if you want to be part of this breakthrough. Go to this page, under stuttering there is a link to sign up (keep in mind to be considered, you have to have stuttered since before age 8 where it has that option): http://www.indevus.com/product/pagaclone.asp?page=pagaclone

[Ster]

http://biz.yahoo.com/bw/060524/20060524005403.html?.v=1
THAT is AWESOME. How long? Wish I could get pagoclone.

[studentdoc]

THAT is AWESOME. How long? Wish I could get pagoclone.
Honestly, from the start of Phase III to release in the market - it usually takes 3 - 4 years. But if you're in the study and you don't get randomly selected for placebo, you'd be on it when that starts (probably within the next few months) :eek: