Intellipharmaceutics International Inc. (IPCI)

[Samsa]

weezhul, again you make unsubstantiated claims. no one can say at this time if they will pass the oral abuse labeling standard. IPCI claimed they do. Naturally, I can not comment too much on what they prior claimed but they did claim they are oral abuse deterrent. Your slim reference to Odidi's claim that it can be chewed like bubblegum as a reason for not passing is immaterial. It does not matter if it is chew-able or not to be oral abuse deterrent, it comes down to the amount of opoid that is extracted. which none of us will know until they conclude all the studies will we?

Abuse by ingestion may involve
orally ingesting physically manipulated (e.g., cut, grated, or
milled) or chewed drug producs.
FDA recommends an oral PK study be conducted on
physically manipulated or chewed products if
the summary in section 9.2 of the RLD
labeling indicates that FDA has concluded that the product has properties that are expected to deter abuse by the oral route
( i.e ., Drug X is expected “to reduce . . . oral abuse when
chewed.”) or FDA otherwise recommends such a study in product
-specific guidance. FDA recommends a potential NDA applicant first conduct comparative extractability studies as described in Appendix 1 to assess the particular vulnerabilities of the T and R
products to inform the comparison of their abuse deterrence. If the potential NDA applicant conducts a PK study, the study should compare the rate and extent of absorption of orally administered
T and R products that are physically manipulated or chewed.
The strength(s) selected for the PK study should be based on the strength(s) used to evaluate the R product’s abuse deterrence.
If the upper 95 percent confidence bound of the T/R ratio for
the rate and extent of oral absorption of the opioid drug substance is less than 125 percent,
then T product passes the test. For agonist/antagonist combination products, T product passes the test if the lower
95 percent confidence bound of the T/R ratio for the rate and
extent of oral absorption of the antagonist is greater than 80 percent. Section VII.A. outlines general recommendations for conducting oral PK studies. Alternatively, the potential NDA
applicant may rely on data from in vitro testing if such methods and data are adequate to compare the rate and extent of absorption of orally administered T and R products to evaluate whether T product is no less abuse deterrent than R product for the oral route.