Intellipharmaceutics International Inc. (IPCI)

[AngeloFoca]

Draft Points to Consider
1.Has the Applicant demonstrated that oxycodone extended-release tablets have properties that can be expected to deter abuse by the IV route of administration?
2.Are there sufficient data to support inclusion of language regarding abuse-deterrent properties in the product label for the IV route of administration?
3.Does the committee have concerns regarding of the safety of exposure to the excipients in this product if administered by the IV route for the purpose of abuse.
4.Should oxycodone extended-release tablets be approved?

Had the panel stayed on course and responded to what the FDA had asked of them... then the answer to all 4 questions would have been a resounding YES !

We got shafted!

https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM568075.pdf

page 6