Intellipharmaceutics International Inc. (IPCI)

[J_Cali]

Opana, my research notes
1. need to inject multiple times
2. Opana injected high doesn't last as long and abusers inject more frequent
3. We don't know we use the exact molecular weight peo Ipci uses
4. I believe opana also contains two ingredients:The inactive ingredients not found in the original version of Opana ER include polyethylene oxide (PEO) and polyethylene glycol (PEG)
5. TMAhas been reported since 2012 (FDA was comfortable no p3, components in wide use)
6. If oxytocin remains on the market don't see huge issue as long as we are non inferior for IV abuse
7. Advisory panel doesn't see need to remove all abuse deferent formulations ....most have peo
8. Tennessee seems to be the hot bed of opanas issues coming to the forefront
Blood journal - The authors hypothesized that the inert ingredient mixture of Opana ER tablets, consisting mainly of high-molecular-weight polyethylene oxide (HMW PEO) of ~7000 kD and labeled as PEO+ might be responsible for inducing acute TMA.

Pg. 206 DPV did not identify any FAERS cases of TMA associated with intravenous abuse of generic oxymorphone products or the PEO-containing opioids, Hysingla ER, Zohydro ER, or Nucynta ER.
https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM545760.pdf

If the minutes get published I'll give them a read.

I am more concerned about not having a US manufacturer named!