July 24, 2017 / 1:23 PM / in 3 months

BRIEF-FDA Staff raises concerns about Intellipharma's opioid painkiller

July 24 (Reuters) - Intellipharmaceutics International Inc -

* 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 Source text: (bit.ly/2tTuo1W) Further company coverage:

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