Endo Pharmaceuticals has completed the initial analyses of the data from an ongoing pagoclone study (IP456-041). Although the study did not meet its pre-specified criteria for success, there were some trends of interest that Endo will look at more closely by conducting additional analyses of the data. The last part of this study will continue until completion late this year. A second active pagoclone study (IP456-039) will be closed in an orderly manner over the next several months. Patients participating in that study will be encouraged to discuss other treatment options with their physicians.
For further questions, please call Endo Medical Information at 1-800-462-ENDO (3636).Endo's statement is in line with my predictions. Pagoclone did not meet the pre-specified criteria for success. Re-phrased for common people: Pagoclone was not successful. ;-) Each trial needs to set a hurdle for success before the trial to avoid shifting the definition of success after data analysis. And the open-label trial of Phase IIa is closing, but the other one is running until the end of the year. They write that "trends of interest that Endo will look at more closely by conducting additional analyses of the data". There are two interpretations, both not mutually exclusive. First, every good PR will add some positive spin or anchor of hope to soften the blow of negative news. We humans need hope when our dreams are hit. They also want to smooth out any hit on their stock price, which has not yet seen a hit by the news. Interestingly, the stock price has been very stable: see graph. Given that the revenues for Pagoclone are now much more likely to be zero, reducing the company's future cashflows and thereby reducing the company value and its equity part. If you have stocks, sell. Or short the stock, sell a future, go long a put or short a call. Second, I would not be surprised if there were pockets of real hopes, i.e. deviations in the data. Some might have responded well while others didn't.The question remains then whether there is a sub-type reacting to Pagoclone. My gut feeling is probably. Maybe for those that are borderline anxiety/panic disorder, which in combination with a low capacity speech system develop significant symptoms. But that's pure and total speculation on my part. A rigorous statistical analysis combined with deep understanding of the nature of stuttering and its traps is needed.
To be crystal clear: Pagoclone is not the wonder drug for everyone many hoped for. At the very best, Pagoclone might be able to modulate the fluency of a sub-type of stutterers. I am sorry to tell you. You will all hate me for spreading the bad news, right? ;-) Tom is just so skeptical and negative. But listen it is not my fault. I am just telling you about reality. I am not creating or causing it!