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.

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

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.

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

Thanks, Robert
 

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

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.

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.

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?

The earlier trials were a success
 

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.

no reason
 

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.

another question
 

Do you have that commitment in writing to let the participants continue on it until approval?

availabilty
 

I agree with you concerning availability of this drug when the study ended. It seems unethical to give patients an improved medicine then "pull the rug from
underneath them" after the trial is over. Especially since the improvement was
noticed the first time I took a dose.
If Impax labs does not want to give us compassionate medicine, then at least
let us have access to buy it with our neuro's prescription. But at least let us
have that option, don't just drop us. IPX-066 pushed my dosaging back to what
it was 6 years ago, 3X daily, as opposed to what i'm taking today, 5X a day.

grrrr
 

That is despicable and they will say you did it for mankind. This isn't going to help us anytime soon [where have i heard that before]?

http://healthpolicyandreform.nejm.or...979&query=home

Any updates?

IPX066 Success
 

I have had no success in getting the company to reconsider their decision to deny access to former trial participants. They are continuing to sponsor new trials of IPX066, but are not allowing previous trial participants to enroll.

I suggest you contact Impax Labs' president and the study director, Dr. Jeff Mulchahey. I can't post their email addresses (due to rules of this site). If you email me, I will try to help you contact them.

I have tried Dr. Mulchahey - no reponse. I have two weeks left and do not want to go back to Sinemet. I know one other participant. Could the three of us send a joint email to Impax, GSK, MJFF and whoever else might help?

Please contact me by email and I will try to help you get in contact with Impax.

Michael J Fox Grant
 

Impax Pharmaceuticals was awarded a Michael J. Fox Foundation Grant for Ongoing Research of IPX066 for Parkinson's Disease last month.

According to the press release,

"The funding will support a planned dosing conversion study of CD-LD ER to IPX066, to be followed by an open-label extension safety study of IPX066 in subjects with advanced PD.

"One of our priorities is to improve symptomatic treatments for patients today," said Brian Fiske, Ph.D., director of research programs at the Michael J. Fox Foundation. "IPX066 holds promise as a potentially useful future treatment option for PD. By collaborating with Impax Pharmaceuticals to develop additional clinical data about IPX066, we hope to gather important information for physicians treating PD and their patients."

Perhaps writing to Dr. Fiske at the Michael J. Fox Foundation will help persuade Impax to revise their decision on denying access to IPX066 to participants in earlier trials.

Thanks. Will do.

My ipx066 trial has two weeks left. The drug has significantly improved the quality of my life with Parkinson’s. It has a compounding effect in that I am able to exercise more which has provided further relief. I am not looking forward to being forced to stop taking ipx066.
In April, I received the following reassurance from Impax.

Dear Doug,



An additional study to allow continued use of IPX066 beyond study PX066-B09-03 is in the advanced planning stage. Please stay in contact with your current trial site for details.



Best regards,

Jeff



Jeff Mulchahey, PhD

Senior Director, Regulatory Affairs

IMPAX Pharmaceuticals,

A Division of IMPAX Laboratories, Inc.

31047 Genstar Road

Hayward, California 94544

USA





In May, the following was announced by Impax.



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.”

In July, MJFF announced the following.

Michael J. Fox Foundation awards Impax $400,000 grant for research of IPX066 for Parkinson’s disease
Published on July 14, 2011 at 9:25 AM · No Comments




Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL), has been awarded funding of up to $400,000 by The Michael J. Fox Foundation for ongoing clinical research of the Company's investigational carbidopa-levodopa extended release (CD-LD ER) product IPX066, which is intended to treat the motor symptoms of Parkinson's disease (PD).

“One of our priorities is to improve symptomatic treatments for patients today”

The funding will support a planned dosing conversion study of CD-LD ER to IPX066, to be followed by an open-label extension safety study of IPX066 in subjects with advanced PD.

"One of our priorities is to improve symptomatic treatments for patients today," said Brian Fiske, Ph.D., director of research programs at the Michael J. Fox Foundation. "IPX066 holds promise as a potentially useful future treatment option for PD. By collaborating with Impax Pharmaceuticals to develop additional clinical data about IPX066, we hope to gather important information for physicians treating PD and their patients."

"We appreciate the support and recognition of The Michael J. Fox Foundation as we further advance the development of IPX066 for Parkinson's disease," said Larry Hsu, Ph.D., president and CEO, Impax Laboratories, Inc.



This August, I called Dr. Mulchahey at Impax. He did not return my call. I emailed - no response.

Please forward this email to Brian Fiske, Ph.D., director of research programs at the Michael J. Fox Foundation.

I wish to ask him if he knew that his stated priority,
“One of our priorities is to improve symptomatic treatments for patients today”
does not appear to be a priority of Impax to whom he awarded $400,000.

Thank you for your time. Please forward to someone who can help.
As Davis Phinney states “Every victory counts”
Thank you for helping turn this defeat into a victory!

Sincerely,
Doug Manuel
253-858-8741

Good News, Bad News
 

The good news is that there is a PR release out today from Impax stating further positive results in another trial.

http://www.marketwatch.com/story/imp...k=MW_news_stmp

The bad news is that Impax continues to treat PWP like lab rats.

Maybe we can get in touch with newspaper reporters who write about this and refer them to this neurotalk thread
http://neurotalk.psychcentral.com/sh...2&goto=newpost

At a minimum, we should post comments on the newspaper site if the article allows it.

time and my study meds are runnine out. If you have been in this study join us snd contact Impax about having our trial meds cut off.
geraldo