Saturday, December 10, 2011

BREAKING NEWS: ENDO STOPS PAGOCLONE.

I have breaking news for you. Endo, the phamaceutical company owning Pagoclone, will stop the trials on Pagoclone completely and focus on their core business model.

As I have already announced, the Phase II trials did not go well (or well enough).

A few thoughts:

1) Endo spent millions on this. Now you know why pharmaceutical companies need to earn a lot of money on successful drugs because they spent so much on those that don't make it!

2) People need to ask themselves why they were part of the hype. And why they interpreted the Phase I and IIa so positively.

3) Thanks to all those who have worked hard to run the random control trials, especially Jerry Maguire. I never shared their enthusiasm, but in science you need to take risks and try it out.

4) This trial has given us information about stuttering, just not the one we want. Endo now has a large sample of control data. We now know much more about the placebo phenomena in stuttering. That is very valuable information, if it is published in a paper...


25 comments:

Olivier said...

What is the source of this confirmation, Tom ?

Tom Weidig said...

Someone who must know and who I trust.

Anonymous said...

Tom means that he read it on another blog about stuttering. The other blogger received (and published) a message directly from Dr. Maguire.

Tom Weidig said...

@Anonym:

I never copy news from other blogs that I have not independently confirmed.

I never reveal my sources either.

Anonymous said...

Is this other blog the stutter-mind-body blog? The information is direct from Dr. Maguire.

Anonymous said...

ONLY THE SHADOW KNOWS THE TRUTH... AND HE AIN'T SAYIN'!

Anonymous said...

Here's the link to some comments within the past couple of days by Dr. Gerald Maguire.

http://stutter-mind-body.blogspot.com/2011/12/breaking-news-about-pagoclone.html

Anonymous said...

While you guys finish your pissing contest, I want to say how dissapointing this news is. Stuttering is like a prison of the mind... Forget being the Vice President of a company.. Forget having confidence in the business world (or personal world for that matter)... I am a bright college educated guy, but I wil only be able to go so far with my disability.. Oh yeah, Stuttering is like being obese, people don't respect you and think you're weak. Not fun to go through.... I'm really sad about Pagaclone!

Anonymous said...

Pagoclone has been around for years and has been at least tested on everything. It isn't available to the public though. Is there any speculation of what it might be tested on next?

Anonymous said...

Pagoclone must not be thought of as a good money maker for the drug companies. But it does alleviate anxiety associated with stuttering with none of the extreme side effects of drugs like ativan or klonopin. It mystifies me that they see no market for pagoclone in a field dense with FDA approved drugs with very harmful side effects. The big Pharms have no sense of what stutters suffer and no urgency in finding suitable medication. I guess that's our fault.

KK said...

Several studies showed that there is the difference between stuttering brain structure and "normal brain" structure. So the pathology is not only on a molecular level (activity of lyzosomal enzymes, dopamine receptors or whatever), but also on a higher level of cells, tissue, neural fibers etc.
You can use drugs to fix abnormal activity of molecules (enzymes, receptors), but you can not use drugs to fix abnormal brain structure.
So I am not really sure whether it's possible at all to develop a drug to "cure" stuttering.

Anonymous said...

I believe studies have also shown the brains of children who recovered from stuttering are also abnormal, so it's not exactly clear what these differences imply in terms of treatment.

Anonymous said...

There are many other medications that may prove useful for your stuttering. Many of the atypical's for instance work on some people.

I am currently taking Latuda for Stuttering. Other alternatives would be Saphris, and there are even generic medications out there if you can deal with the weight gain possibility (I could not).

The latuda has improved my fluency by about half. It is not a magic pill to cure stuttering, but nice to have it.

Keith said...

Please don't limit yourself because of your stuttering. The President & CEO of Energizer Personal Care - like the Energizer Bunny....he has a chronic stuttering condition and is able to function better then most CEO's.

He give quarterly reports in front of 1000's, stuttering the entire time. After seeing & hearing that, and the fact that he is short, I am super confident in my abilities. My stuttering isn't nearly as bad as his, so I have no excuses.

You can google him, David Hatfield, he made 1.9 Million last year.

Anonymous said...

David Hatfield does not stutter and you're advertising a scam.

Anonymous said...

I hope they can find something for us as soon as possible.
Two weeks ago I had to make an oral presentation , I was scared hell and took 1.5 mg of xanax , the presentation went good as I did not stutter...what's sad is the fact that I cannot remember anything of the presentation as I experienced haevy short-term memory loss,It's really frustrating.

Frank

Gerald Maguire, MD said...

I am hopeful that the commercial rights for pagoclone will be purchased by another entity to allow the research in stuttering to continue. In addition, the studies in stuttering revealed a marked improvement in social anxiety which may be another potential FDA treatment indication. We are proceeding in publishing the most recent pagoclone study which does reveal some promising findings. I am hopeful the publication will spark further interest.

I am thankful to the individual who reported improvement with Latuda. This medication, along with other new atypical dopamine antagonists such as Saphris, are generally better tolerated than risperidone and olanzapine. Our university's study of asenapine will begin in the coming weeks and I'll keep everyone on Tom's blog updated with our progress.
Happy Holidays!

Anonymous said...

I think this is sad, I've been following this drug for years and now it's shot down like a plane over the ocean. I can't get the other drugs because the Dr's tells me they have not been "approved" for treatment, but people just wanting drugs can get it anywhere. And where I'm a law abiding citizen I can't do it because I might fail a drug test. I'm so mad about this, I've been off work for two years because nobody will hire me because they think I'm retarded because I stutter. Where can a person turn?!?!?!?!?!?!?!?!!??!!?!?

Anonymous said...

To the last anonymous comment. My advice would be to find a new doctor, and buy a copy of Dr. Maguire's book. Any physician is allowed to prescribe any medication for any reason if they feel it will prove benefit to the patient. This is in the United States, it is called Off Label usage.

My advice would be to meet with a psychiatrist, and talk to them about some of the newer atypical medications.

Anonymous said...

To the last Anonymous: If your current doctor won't cooperate, there may be other doctors who will. Dr. Gerald Maguire is available for remote video consultations via Skype. He will work with your local doctor to prescribe the recommended medication and oversee your treatment.

You can find his email address by Googling him: Dr. Gerald A. Maguire at UC Irvine. When I do that, I get his profile page, which has his email address. http://www.faculty.uci.edu/profile.cfm?faculty_id=3325

Just email him directly. Good luck.

Anonymous said...

Indevus was bought by Endo, and Indevus developed and tested this medication for most of the trials. I question you statement that Endo spent millions. They headed straight down the path of shutting down the trials didn't they? The number of participants was so limited too. What made it so expensive? Not on your blog and perhaps you are out of a loop might be that there are unacceptable side effects

Anonymous said...

This is fucking depressing. I was in the pagoclone trial for over a year and it significantly improved my speech. A week after stopping it, blocks came back and my speech quickly declined. Fuck my life.

Anonymous said...

Nobody knows how sad life we fucking live each day...every morning i wake up and go to my university as a fucking idiot...blocks are ruining my life even though.im on zyprexa but without such big improvements..in each presentation i look like an idiot a psycho and i can't handle it anymore...goodbye to my fucking future

Joel Thinnes said...

I've been on medication for my stuttering since 2007. Dr. Maguire started me on Olanzapine and a very high dose of that reduced my stuttering significantly. I gained weight and was sleeping 12 hours a day. It was a tough trade off but it was worth it because my stuttering is so severe. In 2010 Dr. Maguire suggested I try Saphris. I made the switch and lost weight and now I only need to sleep 10 hours a day. My speech has improved at least 60%. The pharmaceutical companies are coming out with new drugs every year. Saphris is a huge improvement over Olanzapine. And I suspect that they will come out with something better than Saphris relatively soon. If you are a dopamine stutterer there are several drugs that could help you. Saphris, latuda, and fanapt are a few of the new ones that work. If you're a gabba stutterer I know it's dissapointing that Pagaclone didn't work out. But the future looks bright. Some company will pick up on the work that Indevus did and will create an effective replacement for Pagaclone.

None said...

I see Dr. Maguire, and he started me on Saphris as part of his study. That did not help me, and gave me a terrible hang over effect after I woke up, not to mention sleeping ~10 hours a day. He then switched me to 120mg of Latuda, and it has helped significantly. I would say a 60 to 80 percent reduction in blocks. Not a cure by any means, but much better. But Latuda seems to act as a depressant for me, so while my speech was better I was feeling "down" about life and not very motivated to do anything. I talked to Dr. Maguire about this, and a couple of days ago he prescribed Brintellix. Too early to tell if that will help with my depression or not. But it was reassuring that he thought the Latuda could explain my depressed feelings.