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-   -   IPX066 Open Label Extension Study (https://www.neurotalk.org/parkinson-s-disease-clinical-trials/144072-ipx066-label-extension-study.html)

illbethere 01-30-2011 08:12 PM

IPX066 Open Label Extension Study
 
This is a note to those who are enrolled in Impax Lab's IPX066 Open Label Extension Study or anyone else who is concerned about the ethics of PD trials.

IPX066, is an extended release formulation of Carbidopa/Levodopa. I've been taking it for over a year and it has resulted in a significant improvement in the quality of my life.

From what I've heard, it has worked well with others and it's just a matter of time before it is approved for sale.

Unfortunately, I just learned that Impax Labs has not agreed to continue to provide IPX066 until it is available on the open market. This will force me and other enrollees to go back to using an inferior drug like Sinemet, which has a number of nasty side effects, including dyskinesia.

If you agree with me that the sponsor should continue to provide the study drug until FDA approval to those trial participants who request it, then it might be helpful if you wrote a note to the sponsor requesting that they change their policy.

You can write to the study director, Dr. Jeff Mulchahey. He can be reached at *edit* contact poster for details .

The details of this trial can be found at clinical trials.

RLSmi 02-01-2011 12:48 AM

I Googled this trial and find it curious
 
that IPX066, this "new" extended-release carbi/levo formulation, was tested versus a placebo in one trial, and against immediate-release carbi/levo in an ongoing extension of the Phase III trials.

Not surprisingly, the results of the test versus placebo were a substantial (approx. 35%) improvement in the UPDRS parts II and III, reaching the targeted endpoints projected for the trial.

No results have been reported yet for the extension trial versus immediate release carbi/levo.

I wonder if this drug could reach the target endpoints if it were tested versus the already available controlled release formulations, either Merck's Sinemet CR or a generic.

One thing seems clear: If IPX066 is approved by the FDA, GSK and IMPAX will be marketing it at a major price increase over the available comparable drugs.

It is to be hoped that those of us who are successfully using existing controlled release formulations will still be able to obtain them

illbethere 02-01-2011 03:30 PM

Thanks RLSmi for your post.

1. Regarding the comparison of IPX066 to currently available drugs, according to Impax, IPX066:

A. Provides rapid initial increase in concentrations comparable to Sinemet and Sinemet CR; and
B. Maintains sustained concentrations for a prolonged duration vs. Sinemet, Sinemet CR and Stalevo.

There's a chart in a presentation they made at a Jefferies conference that shows the data.

You can google "IPX066 Jefferies" to find it.

2. I see no reason why the availability of IPX066 will in any way affect the availability of existing drugs. Also, you're right that IPX066 most probably will be higher priced.

3. I participated in the ongoing double blind trial in which IPX066 was compared to Sinemet. It was very obvious to me when I had taken IPX066 and when I had taken Sinemet. IPX066 was far better at eliminating my PD symptoms and one dose lasted about 50% longer. BTW, I previously tried Stalevo, but had to drop it due to severe side effects. From what I can recall, IPX066 worked much better than Stalevo.

4. Finally, my main reason for posting this topic is not to compare one drug vs another, but to raise the ethical question of whether a drug company should continue to provide a trial drug to test volunteers if it is working far better than available alternatives. I feel very strongly that the drug company has this obligation in return for the test participant taking whatever risks are involved in the test program. I hope you agree with me and will contact Impax Labs to support this position. Thanks.

RLSmi 02-01-2011 07:13 PM

Illbethere; Roger, will do!
 
I did recognize that the primary purpose of your post was to call attention to the questionable (at least) ethics of refusing you who participated in the IMPAX trial access to a drug that seems to be highly effective in treating your symptoms.

I definitely will contact IMPAX and protest their lack of compassion in withholding IPX066 from trial participants who experienced very positive results and who wish to continue to use it for your own benefit.

In view of the past history of big pharma in such situations, I would be cautious about holding my breath while waiting for them to grant such compassionate access.

Robert

illbethere 02-01-2011 07:28 PM

Thanks, Robert
 
I really appreciate your support. Hopefully, many others will contact Impax.

illbethere 03-16-2011 11:16 AM

IPX066 Success
 
Yesterday's press release from the company states that it has had success in its two double-blind trials and that it will file for FDA approval in the 4th quarter of 2011. This implies that approval will probably not be granted until late 2012.

Please contact the company and request that they extend the open label study until FDA approval is received.

Thanks again for your help.

illbethere 05-04-2011 04:39 PM

Impax cancels IPX Open Label Extension Study
 
Impax, the sponsor of the IPX066 trial just sent out the following message:


“Our internal work on the new open label extension study was put on hold while our Senior Management reviewed our projects, resources and budgets.

Today we learned that we will not be moving forward with this study.

We will, however, be working diligently to submit our NDA [Impax’s request for FDA approval of the study drug so it can be made available to the public] this year so that IPX066 will be available to patients once it is approved.

We appreciate all of your efforts on our studies and know that this will be disappointing to your study staff and the patients.”

This is really bad news for those of us who volunteered to take the risk of being in the IPX066 study and now are being sent back to drugs like sinemet, which have serious side effects. It seems to me that they have used us and, having gotten the data they need, now feel no obligation to us at all.

paula_w 05-11-2011 07:27 AM

being used
 
Many clinical trial participants feel that way after they find out it's canceled. i'm sorry for yet another disappointing story about a treatment not making it past phase 2. did they tell you why? did they provide any results?


Quote:

Originally Posted by illbethere (Post 767633)
Impax, the sponsor of the IPX066 trial just sent out the following message:


“Our internal work on the new open label extension study was put on hold while our Senior Management reviewed our projects, resources and budgets.

Today we learned that we will not be moving forward with this study.

We will, however, be working diligently to submit our NDA [Impax’s request for FDA approval of the study drug so it can be made available to the public] this year so that IPX066 will be available to patients once it is approved.

We appreciate all of your efforts on our studies and know that this will be disappointing to your study staff and the patients.”

This is really bad news for those of us who volunteered to take the risk of being in the IPX066 study and now are being sent back to drugs like sinemet, which have serious side effects. It seems to me that they have used us and, having gotten the data they need, now feel no obligation to us at all.


illbethere 05-11-2011 03:05 PM

The earlier trials were a success
 
Quote:

Originally Posted by paula_w (Post 769419)
Many clinical trial participants feel that way after they find out it's canceled. i'm sorry for yet another disappointing story about a treatment not making it past phase 2. did they tell you why? did they provide any results?

Paula, the IPX066 open label extension that was cancelled was a follow-on to several earlier successful trials. The company had promised that participants in those earlier trials would be able to continue to use the test drug (IPX066) until it was approved for sale. The company changed their mind and cancelled the extension, thereby forcing the trial participants back to inferior drugs like sinemet. They didn't say why they changed their mind, but I suspect it was due to the fear that they had little to gain from the extension and possibly a lot to lose if abnormalities showed up in the extension.

paula_w 05-12-2011 01:18 PM

no reason
 
Quote:

Originally Posted by illbethere (Post 769560)
Paula, the IPX066 open label extension that was cancelled was a follow-on to several earlier successful trials. The company had promised that participants in those earlier trials would be able to continue to use the test drug (IPX066) until it was approved for sale. The company changed their mind and cancelled the extension, thereby forcing the trial participants back to inferior drugs like sinemet. They didn't say why they changed their mind, but I suspect it was due to the fear that they had little to gain from the extension and possibly a lot to lose if abnormalities showed up in the extension.

iF you can, round up many more participants and DEMAND an explanation.

please don't just accept what they've done. It should be a crime.


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