Sunday, September 25, 2016 10:23:10 AM
How is Rexista different from Opana? They have very similar crush-resistant ADF mechanisms. Turned out Opana could be crushed and injected, and the filtering process and particulates caused huge problems, including HIV and Hep C outbreaks, infectious endocarditis, and an acquired clotting disorder. Endo was warned about these issues as early as 2013. It's a perfect example of how the ADF version made a drug MORE DANGEROUS, and an excellent analogy for Rexista with its deadly stigmatizing blue dye ADF.
Is there any evidence that Rexista will not have the exact same crushing issues that Opana has? Where are the HAL studies for Rexista? For a drug that is now two quarters behind schedule for NDA application, the data package should be complete. Why have there been no updated data slides in any corporate presentations regarding Rexista, particularly the HAL studies? Compare this to virtually any other ADF project from a public company. If the ADF works and the HAL studies are good, publicly-traded companies tout them every chance they get. If the ADF sucks and so do the HAL studies, then companies tend to do, well, exactly what IPCI is doing, pretend they don't exist.
The idea that Rexista is "Best In Class" at anything is a fantasy that exists only on this message board. No HAL studies. No safety study. No updates. After their experience with Opana, Endo will not be interested in an untested, untried "crush-resistant" ADF that contains a ticking-time bomb that could cause legitimate users to turn blue and die.
Historic note: Until his life's destiny was further clarified, Robin Hood spent several years robbing from the rich and giving to the porcupines. (G. Larson 7/26/82)
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