From a column in Kauppalehti, one writer had called Nanofirm’s IR director and asked about these Cmax issues. Apparently, the problem has been Cmax exceedance in the fed state.
“I looked into the matter and it’s about Cmax exceedance in the fed state, i.e., after a meal. This is because the original Xtandi/Enzalutamide tends to have a significantly larger drop in drug concentration after a meal than Nanoenzalutamide, and this causes the exceedance.”
If I remember correctly, in fasted trials, Cmax had previously been low compared to the reference, and now it’s apparently high compared to the reference in the fed state. The Cmax of nanoenzalutamide should then fall somewhere between the reference values and be independent of eating. Theoretically, this could even be better than the reference, as the drug concentration doesn’t fluctuate as much. Now the only open question is how to get this through the EMA’s gauntlet most easily?