Why did they choose to use 6 mg instead of 9 mg, for safety?
BTW- all of these studies agreed upon with the FDA through a SPA, which SNTS has followed.
The 9 mg dose significantly induces remission (the primary indication, better than current therapies), while 6 mg dose does not in the 8 week study. The 6 mg dose was safe over 12 months (when given to patients after receiving the 9 mg dose in the induction of remission study), but was not effective in maintaining remission (the study was not powered to show this, significantly). Trend to longer relapse for patients on budesonide MMX vs. placebo.
The NDA filing will be a 505 2b filing for using the 9 mg budesonide MMX dose for inducing remission. This being the case, they can reference all of the data used for Entocort EC, so should be OK as that was safe and effective for treating Crohn's Disease at the 9 mg dose.
Just wish they would clarify the use of the 6 mg dose better, in light of the new results.