Intellipharmaceutics International Inc. (IPCI)

[WeeZuhl]

Dangerously incorrect.

It seems Oxycodone ER is basically a generic of Oxycontin. I am guessing FDA will not hold another Advisor Committee meeting since is it so close to being a generic. All IPCIF has to do is show Oxycodone ER is equally as abuse-resistant as Oxycontin to get approved. IPCIF claims Oxycodone ER is bioequivalent with or without food so the drug meets the requirement to be generic AB-rated.

It is interesting to see others finally agree with what I was saying over & over, which is that Rexista is nothing more than a generic Oxycontin clone. I repeatedly advocated that they withdraw the NDA and submit an ANDA for generic Oxycontin, but they didn't. They continue to pursue this drug via the NDA route, which is important for multiple reasons. First and foremost, there is no such thing as a "generic AB-rated" NDA, as is implied by this post. If it does get approval as NDA, it will not be eligible to be automatically substituted for Oxycontin like other generics would be. Second, as an NDA, the abuse-resistance features will **NOT** be compared to **JUST** Oxycontin. It will also be graded against every other oxycodone ER NDA, including Extampza, which has an oral abuse ADF label, unlike Oxycontin.


In summary, the company did not take my advice and submit oxycodone ER as an ANDA. As a result, their drug will need to prove abuse deterrence as good as all other NDA's, which means it will need a successful chewing study. No PEO-based drug like this has ever had a successful chewing study. Supposedly, the study has finally been done, so where are the results of IPCIF's chewing study??? That's a question I've been publicly asking for longer than 4 years now. Looks like we'll have to wait for AdCom #2 to find out the results, which brings us to the third way this post is incorrect. There most definitely will be an AdCom in order to discuss the nasal and chewing HAL studies, which were notably absent at AdCom #1.


If IPCI wanted the advantages of an ANDA application, they should have submitted one. NDA's play by different rules, and those rules are not in their favor for this particular drug.