I have every expectation that by the end of june the Oxypatch will be cleared to start Phase III whenever the company deems appropriate.
I didn't come away with that expectation necessarily but others feel free to correct me if I'm wrong. There was some discussion on whether Phase 2 was necessary for both Oxycodene and Oxymorphone. My impression was that it would be likely that Oxymorphone will go through a Phase 2 trial and likely that Oxycodene would go straight to Phase 3 but not a foregone conclusion. In other words I don't believe a final decision has been made on the next path as yet.
The discussion was based around whether it is actually advantageous, less risky and ultimately cheaper to perform smaller Phase 2 trials first. What was clear is that Phase 1 only tests the success of delivery of drug into ths skin and is tested on healthy people whereas a Phase 2/3 aims to prove the efficiency of delviery of drug with pain releief success. It was interestingly highlighted that pain can be a subjective matter and often a component of this is psychological so tests need to cater for this. 'Macca' told us a story of someone who was given a placebo and had episodes of fainting claiming that the 'placebo' drug was causing it.
So in summary, we may see a Phase 2 oxycodene yet but less likely than Oxymorphone as morphone's development has been much shorter and is less advanced.
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