Replies to post #21062 on Intellipharmaceutics International Inc. (IPCI)

[Samsa]

Numbers......doesn't the fact that Rexista is being labeled as XR denote that it does last 12 hours? Its been a while but I recall there is a difference between XR,ER,CR or CD ? I thought to meet an XR indication it had to last 12 hours? I may be wrong its been some time since I read up on it.

[doogdilinger]

IPCI doesn't have to make any claims or do studies showing "superiority" over Purdue's OxyContin(only that it's BE). It's already been well established by thousands of OxyContin users that Purdue's Oxy wears off after 8 hours while according to IPCI's most recent studies Rexista lasts the full 12 hours.

The potential future Rexista best-in-class designation isn't anything more than Doctors/subscribed users recommendations/beliefs from their own personal hands on experience once drugs are commercialized.

So not only does IPCI not have to go around advertising what Doctors/users of Purdue's Oxy have been saying for years...they simply have to let their studies speak for themselves and wait for Doctors/subscribing users to share their real world experience when Rexista hits the market...because if Rexista gets the deemed best-in-class designation then IPCI and their Rexista partner will take a big chunk of the available market share>>>

Dr. Isa Odidi, Chairman and CEO, stated, “The FDA waiver of the NDA application fee is a welcome decision in our development of Rexista™ XR. In addition, we believe the food effect studies demonstrate that RexistaTM XR taken under fasted and fed conditions is bioequivalent for all pharmacokinetic matrices studied and has no food effect, and that RexistaTM XR is well differentiated from currently marketed oral oxycodone extended release products, one of which is labelled to be taken with food due to food effects and the other whose Cmax matrix has been reported not to be bioequivalent under fasting and fed conditions.”