Replies to post #18360 on Intellipharmaceutics International Inc. (IPCI)

[Samsa]

Mopar...good reply, you beat me to it. Weasel is out of gas on this. I certainly wouldn't want him as my lawyer but would love him as opposing counsel. His connection he is trying to make is ill founded. 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. LOL it would have been different if the FDA said by causing only a flushing effect is not a deterrent. but they didnt say that. they actually hinted that they would allow it, if it still worked with the food study thereby reinforcing a green light for Rexista. I say bring it on, Rexista will be the new "blue Pill" and no copyright infringement is intended against Pfizer for that one LOL. matter of fact seeing how well Pfizers other blue pill worked maybe they will look "harder" at partnership with Rexista? LOL sorry couldnt resist.

[WeeZuhl]

I apologize for assuming facts not in evidence...

No the link says nothing about legitimate users. The link says it doesn't work as stated because eating cancels out the effect.

I forget sometimes that no one here has my same knowledge, training, and breadth of experience to understand both the historical and biochemical context of these meds.

Niacin is no longer recommended for any reason, but back in the day, when niacin was used for dyslipidemia, especially hypertriglyceridemia, it was not easy for some patients to titrate up to an effective dose due to flushing that occurs with standard doses. This flushing reaction for legitimate users was very much a part of the AdComm discussion and is precisely the side effect he is referring to when he says no advantage but with possible side effects.





http://www.medpagetoday.com/psychiatry/addictions/25888

Last year an FDA advisory committee gave a thumbs-down to a version that also contained niacin as a means of preventing oral abuse.

Niacin, which can induce a chemical flush, was added as an extra disincentive, but critics said the flushing, could be easily defeated by taking an aspirin or even just food with the drug. Also there was concern that niacin could cause flush even among people who took the medicine as directed.