Pagaclone?

[controlledchaos]

Any updates on this medication or has the FDA x'ed it?

[Roley]

I've just taken it upon myself to send an e-mail to Dr. Gerald Maguire at the University of California, to ask for an update. He's a fellow stutterer and has been involved with the study of Pagaclone. I haven't seen any concrete information on Pagaclone in the past year or so. I'll let you know what I hear. In meantime, please let us know if you have more information yourself.

[EddieO]

They even mentioned the medication on 20/20. They said it hasn't been approved yet, which we already knew that.
Eddie

[Chad]

Here is the latest I've heard, from a popular stuttering blog:
http://thestutteringbrain.blogspot.com/2008/02/whats-next-in-crystal-ball.html

Also, the last time I spoke with Dr. Maguire at UC Irvine, the phase III trial had continually been getting pushed back and they were hoping to start up again within 3 months. But I think the link above sheds more light on the situation.

[BenLZ]

They are finished with Phase III, but the research is being turned over to another company and when my mom called up they put the time between 10 months to a year before its marketed to the general public. My suggestion would be to try and call up for a trial as soon as stage IV commences (there are 5 of them).

[gm0730]

So they are predicting pagaclone will be available to the public within a year? I thought FDA approval would take more like ten years

[MaryVT]

The 10 years refers to the total time it takes to develop, test, and bring the drug to market - not just the time the FDA reviews the drug data.

[controlledchaos]

Hey guys,

I appreciate the updates, it seems that this medication may be the single best individual pharmaceutical solution for stuttering. I will watch out for it on my clinical rotations in medical school. Doing rotations kind of sucks when I stutter but whatever, many more ahead of me made it through, so I can't complain. Wish you all luck.

-md

[Eric NYC]

Any updates on this medication or has the FDA x'ed it?
I called Indevus, the company that owns the rights and has been sponsoring the Phase II trial. The results of the Phase II trial were positive, and about 18 months ago they said they would proceed to a Phase III trial. But it hasn't happened yet.

I spoke with them in December and they said that they are still positive on the drug. However, the company's main focus has shifted toward other drugs (urological, etc.) and they have decided not to develop pagoclone themselves. They are looking for a partner/licensee to proceed with it. The expected to reach an agreement by the end of the year.

There was no announcement of that, so I called them again a couple of weeks ago for an update. They said were overly optimistic in December when they anticipated that a deal would be completed by end-of-year. However, they are continuing talks with more than one company. The spokesman described them as "late stage discussions", not preliminary or exploratory talks. They still consider pagoclone a valuable asset for their company and would like to see it developed. The remain optimistic that they will conclude a deal, although this time they did not want to project a date.

[Eric NYC]

They are finished with Phase III, but the research is being turned over to another company and when my mom called up they put the time between 10 months to a year before its marketed to the general public. My suggestion would be to try and call up for a trial as soon as stage IV commences (there are 5 of them).
That's not correct. They are finished with Phase II, but have not yet begun Phase III. They're looking for another company to develop it, and that other company would undertake the Phase III trial. See my other post dated today for further info.

[studentdoc]

Hey guys,

I appreciate the updates, it seems that this medication may be the single best individual pharmaceutical solution for stuttering. I will watch out for it on my clinical rotations in medical school. Doing rotations kind of sucks when I stutter but whatever, many more ahead of me made it through, so I can't complain. Wish you all luck.

-md

I'm finishing up 3rd year rotations... it's not as bad as you think :-)