Advances Of Pagoclone

[stardust]

Indevus annouced another advance in the future comercialization of pagoclone.
Here is a partial note of the news:

Indevus Announces Agreement With Teva to Develop Pagoclone for the Treatment of Stuttering
Friday September 26, 10:30 am ET


LEXINGTON, Mass., Sept. 26 /PRNewswire/ -- Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV - News) today announced that it has signed a development, license and commercialization agreement with Teva Pharmaceutical Industries Ltd. for the exclusive, worldwide rights to pagoclone. Indevus previously announced promising data from its 8-week, placebo controlled, double-blind, multi-center Phase II trial in patients with persistent stuttering which showed that pagoclone produced a statistically significant benefit in multiple primary and secondary stuttering endpoints compared to placebo. Pagoclone is a novel member of the cyclopyrrolone class of compounds and acts as a gamma amino butyric acid (GABA) selective receptor modulator.

[urbanmermaid]

u know what this means... Pagaclone will be comercialised woohoo :P
sucks it will be in 2 yr's time tho...

[urbanmermaid]

forgot to say many thanks for posting this!! :)

[Derek181]

i cant wait for this stuff to come out. i wonder what the cost will be. so in 2010 it will be out?

[urbanmermaid]

hmm good question. since theres only one company thats making it i bet it wont be cheap. i tend to avoid super expensive things that promise miracles but this one will be worth a try

[studentdoc]

This is huge. Indevius (IDEV) stock went up over 100% on this news. http://biz.yahoo.com/prnews/080926/nef016.html?.v=64

[Box of Clocks]

Thanks for the information. It will be interesting to see how beneficial to stutterers the drug is once it is released and also how much it will cost as has already been mentioned.

[Theycallmeb916]

Thanks for sharing this! Something to look forward 2 hehe, Finally something might help stuttering. <3

[Vermillion]

yeah..

their stock jumped big time

[Stevelaz]

At last !!!!!.........the papers are signed and the trials are going ahead.

Note its a FDA Phase IIb trial as opposed to a Phase III trial.......I've asked Dr Maguire what the difference is, and once I hear back, I will let you know.

With 3 million stutterers in the USA and many millions elsewhere, it will be a nice moneyspinner for the drugs company....the share price went up nicely...wish I had bought a few shares ahead of the announcement !!!!

It wont be a cure, but it should help many sub-types of stutterer.....I think this drug linked with therapy will make great strides in helping us.

I suspect it will be available in 2010/2011 if all goes well......in the USA, not sure about Canada though, we always seem to lag behind a bit with drugs and release of them.....

Has anyone here been on the phase II trial? and how did you get on with it.....results wise

[studentdoc]

Has anyone here been on the phase II trial? and how did you get on with it.....results wise

I tried to sign up and they filmed me read some passage and I didnt qualify for the trial. But I've requested on the website to be a part of Phase III so I can get my hands on the drug before it's released (unless of course I'm in the control group and given placebo)

I don't know what Phase IIB is, never heard about it in med school.

[studentdoc]

Long live Wiki:
"Phase II studies are sometimes divided into Phase IIA and Phase IIB. Phase IIA is specifically designed to assess dosing requirements (how much drug should be given), whereas Phase IIB is specifically designed to study efficacy (how well the drug works at the prescribed dose(s)).

Some trials combine Phase I and Phase II, and test both efficacy and toxicity."
Source: http://en.wikipedia.org/wiki/Clinical_trial#Phase_II

[Stevelaz]

StudentDoc,

Thanks for the info on Phase 11b trials.

What was the criteria for being accepted on the trial (severity/frequency etc?)

[Derek181]

it doesnt seem like it will be available for at least another 3 to 4 years!!!!! that sucks big time i wanted to try this stuff out sooner.

[studentdoc]

StudentDoc,

Thanks for the info on Phase 11b trials.

What was the criteria for being accepted on the trial (severity/frequency etc?)

I believe both severity and frequency ...

Derek181, why don't you sign up for the trial and you won't have to wait.

[urbanmermaid]

hmm.. why do some ppl first say 2-3 yrs then suddenly we're talking about 4 yrs.. this is a very long time. can someone estimate roughly the duration of the next phase trials? they cant go on for years surely?

[thatCALIdude]

hmm.. why do some ppl first say 2-3 yrs then suddenly we're talking about 4 yrs.. this is a very long time. can someone estimate roughly the duration of the next phase trials? they cant go on for years surely?

drugs take forever to get approved, 2-5 years is usually the normal time period. i dont want to be a guinea pig but if you want it sooner thats your only alternative.

[Derek181]

i dont stutter severely enough to be considered.

[urbanmermaid]

i dont stutter severely enough to be considered.

me either, but we can pretend lol ;)

wont work for me tho because i dont live in the us

[Derek181]

yah i dont live in the US either. You COULD pretend but iam sure they would catch on and figure you out pretty quick hahah. i think you have to be very severe wtih a high frequency of stuttering. i stutter a bit here and there but i know if i was put into a situation where they video taped me or something i probably wouldnt stutter once. i guess i will just have to wait the years and years before its out on the market to try.

[Jamus]

I signed up. I'm not exactly happy to say this, but my stutter is I believe definitely severe enough to be considered for the trials. We'll see what happens.

[Silent]

Indevus seems to accept people from other countries, at least so it looks from the application form.
What is the 'right' answer to the question: "Did symptoms of stuttering occur prior to age 8?"? I mean which one won't get me rejected? My stutter started when I was 8 as far as I remember, but there could have been minor dysfluencies before that I didn't pay attention to.

[Vermillion]

Indevus seems to accept people from other countries, at least so it looks from the application form.
What is the 'right' answer to the question: "Did symptoms of stuttering occur prior to age 8?"? I mean which one won't get me rejected? My stutter started when I was 8 as far as I remember, but there could have been minor dysfluencies before that I didn't pay attention to.

link to application form?

If you say your stuttering occured before age 8 then you would probably have better chances.

[Silent]

link to application form?

If you say your stuttering occured before age 8 then you would probably have better chances.
Thanks. I selected "before 8", hopefully it will help.

http://www.indevus.com/site/index.php?Itemid=45&id=31&option=com_content&task=view#
You'll find the link at the bottom, in the paragraph "If you are an individual who stutters, or knows of someone afflicted by the condition, and are interested in being considered to participate in clinical trials, please click here (http://www.indevus.com/forms/pagoclone/trial_participants.php)"

[couture57]

I just signed up - I hope I am chosen for the trials, but I'm not getting my hopes up. Pagoclone probably won't work for me, anyway, or they will not let me do the trial because of all the other meds I already take (for bipolar disorder and other medical problems).

But it might be worth a try, anyway.

I wonder if insurance will pay for the drug when and if it is finally available? My insurance won't pay for speech therapy or devices, since they consider stuttering to be a non-medical condition. I guess the idiots subscribe to the "well, just don't be so nervous and you won't stutter" school of stuttering theory. :rolleyes:

[Silent]

they consider stuttering to be a non-medical condition. I guess the idiots subscribe to the "well, just don't be so nervous and you won't stutter" school of stuttering theory. :rolleyes:
I don't think they subscribe to any theory, they just - understandably - want to maximize their profits ;)
However, scientific evidence that stuttering IS a medical condition, could probably be used to bust this practice... But do we have any evidence?

[Ayman]

lol urban mermaid so excited :)

i cant wait too, but in 2 years time i will be graduating lol but it will come to use after uni as well but oh well

thanks for posting

[urbanmermaid]

im graduating in exactly 2 yrs too lol
if they have already signed a contract for comercialisation why do they have to delay it for yrs grrr
lol ;)

[Ayman]

i study pharmacy and i know the drug trial process, apparently it needs a lot of time (around 12-14 years from the discovery till marketing) and alot of money (300million dollars+), they also have to submit a 2000 page report about the drug trial phase 1,2,3 etc to FDA, takes months to read it and if theres nothing wrong with it then they release the drug, if theres only one mistake in the report, they return it and decline it for another 6 months, american FDA are a shitty company, not like NewZEalands pharmac hehehe

anyways goodluck with ure graduation and hopefuly this drug can help us both out :)

[couture57]

I don't think they subscribe to any theory, they just - understandably - want to maximize their profits ;)
However, scientific evidence that stuttering IS a medical condition, could probably be used to bust this practice... But do we have any evidence?

If pagoclone proves to be as good as they are hoping it will, during these trials, not like the hit-and-miss benefit from using other drugs off-label, that may be the best evidence of all.

I am convinced that eventually a specific organic cause for stuttering will be found through research. Then the medical will finally wise up and realize that stuttering is not merely a behavioral or psychological issue, but a treatable medical condition. Of course, I've thought that for 40 years, and it hasn't happened yet, but I haven't quit hoping.