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.