Replies to post #18372 on Intellipharmaceutics International Inc. (IPCI)

[WeeZuhl]

I can tell you're trying...

the FDA didnt reject the other drug because it created the side effect of flushing but saying by eating food it took away the desired effect therefore it was no longer a deterrent. so to do an accurate comparison, IPCI wants to turn lips or fingers blue if you crush the pill as a deterrent. as long as eating food doesn't take away that effect it still works.

The AdComm specifically rejected the drug because the ADF additive did not work but did cause side effects. So again, even if IPCI can prove blue dye safety for this novel use, which they cannot and have not, then they still have to prove it works as an ADF. With today's FDA, you can't just say your pill prevents chewing, you have to PROVE IT. How do you prove the blue dye (specifically, the blue dye) prevents chewing?



https://globenewswire.com/news-release/2016/09/26/874482/0/en/Complete-Response-Letter-for-REMOXY.html

Details of the Complete Response Letter (CRL)


In addition, we had proposed in the REMOXY NDA a label claim against abuse by chewing. Our proposal was based on clinical results of an oral human abuse potential study that met all four co-primary endpoints with statistical significance and that also met several, but not all, secondary endpoints. The CRL asks us to submit a revised proposed label to indicate results of this study do not support a label claim against abuse by chewing.

[mopar44o]

Exactly. Dobt get me wrong maybe blue dye will be bad. But he hasent shown me anything to suggest it.