Thursday, June 14, 2007

New Pagaclone results are out!!

Indevus today announced some further results of the Phase II pagoclone trial, along with some results from the 3-month open label period (after the 8-week initial double-blind trial), see here. More later.


Unknown said...

Hi Tom, I know this question may seem crazy but what are your honest thoughts. Do you think Pagoclone will be approved by the FDA? There is one more Phase before they can submit to be approved, correct?

I have been trying to keep my hopes down but all honestly, it is exciting stuff. I know it's not a cure but I really feel that improvement would really build my confidence and let me do some things I have always wanted to do.

Keep up the great blog! Nice to read a blog about stuttering that is not all advertising and just pure facts and discussion! Rock on.

Dave from Boston, Massachusetts

Tom Weidig said...

Yes, one more phase.

The planning for Phase III is finished now and I think they start soon or have already started. Phase III is mainly a more large-scale Phase II trial.

Sometimes the FDA approves at Phase II if there is very clear evidence exists and the drug is already used for other conditions.

But I am no expert in all this.

I guess they will improve but improvement might not be sensational and not for everyone. Probably most severe stutterers will benefit most.

Anonymous said...

To be honest, I don't care about the efficacy of Pagoclone. As many other treatment, I think it will work for some stutterers but not for some others.

To me, the point of Pagoclone is, finally, people are investing large sums of money in treating stuttering, and behavioral therapy is not the only choice. Money may not ensure a better treatment result, but without money you cannot advance in digging out new treatment possibilities.

I do hope Pagoclone could be approved by FDA soon.

Unknown said...

Tom, One more question if you don't mind...

How long does a Phase III typically last? Would it be a whole year before anything or will they speed it up a bit for quicker approval? Again, not sure if you know or heard the timing of phase iii trials.

Thanks again, I appreciate your time in these replies.


Dave Rowley said...

Just had a quick look at the study Tom referred to. Two points already concern me: It states 'More than 70% of the 119 patients who entered the open label phase of the EXPRESS trial were included in the three month open label data being presented at NCDEU.' Why not all of them? Second, Pagaclone showed similar results for reducing panic attack after aphase II study. A summary is here:
but was never marketed for this. The company has halted research on pagoclone as a treatment for premature ejaculation, citing lack of efficacy data from a Phase II trial. So, please don't get your hopes up just yet. You may also be interested in the abuse potential of Pagoclone:

Anonymous said...

The NIH (National Institutes of Health) runs a web site on clinical trials. Here's some info on what the phases mean:

The same site lists trials that are recruiting. However, for pagoclone, it's clearly not up to date because it indicates the Phase II trial is still recruiting, but we know that it ended some time prior to September 2006, when Indevus announced the results.

It's possible to register as a candidate for the Phase III study at, which I've done. I've spoken with a psychiatrist friend of mine who says that the participants in a clinical trial are often given the opportunity to continue using the drug after the trial, during the licensing phase.

Unfortunately the post-trial evaluation followed by the licensing phase can take some time, measured typically in years, not months. The FDA will speed it up for drugs with widespread value or lifesaving potential, however, it's hard to imagine that an anti-stuttering drug would qualify for such accelerated treatment.

Anonymous said...

I think it is a life-saving drug in a sense. I could not get a job in the crappiest company in any industry.

Of course nobody would say the truth, but one guy (out of high rapport and care) told me that the real reason is your stuttering and even if you will sue them, they will make some other excuse and you will waste your money.

Ivy League, 3.9/4.0, wherever I drop my resume, I get the interview, even second interview, but never got the job. Of course my target, as for all Business majors, Investment Banks. From that to a crappy newspaper selling hut. Even he refused.

I was about to commit suicide after that point. No joke. I went to a store to buy a gun and shoot myself in my car. The guy said you need some kind of license to buy the gun.

So as I was driving in deep depression, I hit somewhere, and went into paralysis. I guess it was not time for me to die then.

Point is: if FDA or whatever authorities know the facts how hard stuttering makes the lives of people, it sure should be classified as a life-saving drug.

Anonymous said...

hang in there. pagaclone has at least put a spotlight on these types of treatments (and the $ that can be made from them).

Anonymous said...

dave said:
Second, Pagaclone showed similar results for reducing panic attack

Hi !
in my opinion the (anticipated) stuttering goes into the same direction like panic attacks. Reducing these symptoms will reduce stuttering. So i think, Pagoclone will definitely help reducing severe stuttering.

I still doubt that Pagoclone is reducing the real cause of stuttering, but on the other side,
i think it will get us a step closer in finding the cause by reducing all symptoms that reinforce stuttering :-) !

Anonymous said...

anonymous - Have you investigated olanzapine (Zyprexa) for stuttering?

There's some information here:

You can order and download the full article online on a couple of sites for $30 or $40. (I have a hardcopy and would be glad to send you a copy by snailmail. Send me a note at: omccreary (at) nyc (dot) rr (dot) com. )

Gerry Maguire, the principal author of the article (and also the principal researcher for pagoclone) is an MD and a stutterer and has been taking olanzapine himself for a number of years.

Unknown said...

Thank you all for answering my questions.

Lets hope this drug goes through and has a positive effect for us. I guess my hopes are already up but how can we not. If we say we don't, I think we're lying because deep down inside we would be very happy!

Anyhow, good luck to all of you and have a good weekend.

By the way, I'm a Wedding DJ and stutter, I have it mastered! haha, seriously.


madhu said...

Lets hope that the Pagoclone will be approved by the FDA. But will it pass the drug test.

As far as the passing the drug test is concern, I tried this detox drinks and capsules, which is available and passing a drug test was easy, it really worked. Now I am in to new job too. Got out of depression too.

Anonymous said...

Thanks for article!

Anonymous said...

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Anonymous said...

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Anonymous said...

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Anonymous said...

After reading the article about he young man who couldn't even get the crappy job and wanted to shoot himself, I got scared as I feel this is where my son is. I have done research on pagaclone and would give anything if it works. We have been going to speach theropy twice a week and I see no results. So, I did my own study, I gave him a Valium, he is 24. Within 30 minutes he was able to read a paragraph with no trouble, he called for an interview with no trouble and had several phoe conversations with no trouble. I am headed to the Doctor's ASAP. I am not suggesting this to anyone, just that if you are relaxed so is your speech. What do you think?

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