July 24 (Reuters) - Intellipharmaceutics International Inc IPCI.TO -
* FDA Staff: no new safety signals were identified with Intellipharma's opioid painkiller Rexista beyond what is already known for oxycodone products
* FDA Staff: Intellipharma's opioid painkiller Rexista tablets are relatively easier to reduce into fine particles than OxyContin tablets
* FDA Staff: most solvents had similar or lower extraction recoveries from Rexista tablets than from OxyContin tablets
* FDA Staff: at the correct combination of testing conditions, Rexista tablet samples were similar or less syringeable than OxyContin
* FDA Staff: not easy to separate/eliminate blue dye & nasal irritant in Rexista, without using extensive chemistry knowledge
* FDA Staff: using complex extraction procedures, oxycodone base can be achieved with similar or lower purity & yield from Rexista than from OxyContin
* FDA Staff: varying extent of physical manipulations progressively increase the oxycodone dissolution rate from both Rexista and OxyContin
* FDA Staff: even with the largest extent of manipulation, Rexista still retained some extended-release characteristics
* FDA Staff: Rexista tablets are less efficient to vaporize than OxyContin tablets
* FDA Staff: There were no human abuse liability studies submitted with the marketing application for Rexista
* FDA Staff: Safety info collected in Rexista pharmacokinetic studies was of limited value since these were generally single-dose studies