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

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.

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?

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.

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