Originally Posted by illbethere

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.

Originally Posted by paula_w

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?

Originally Posted by illbethere

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.

Originally Posted by doug manuel

Any updates?

Originally Posted by illbethere

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.

Originally Posted by doug manuel

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?