Replies to post #23238 on Intellipharmaceutics International Inc. (IPCI)

[numbersarefun]

WeeZuhl, FDA did not grant Oxycontin's sNDA Pediatric_Exclusivity. From the Review documents, the Summary Review said: "The requirements of PREA (Pediatric Research Equity Act) are triggered by a new indication, a new dosage form, a new route of administration, a new dosing regimen, or a new active ingredient. Because the reformulated OxyContin was approved while the older formulation was still marketed (and is not considered a new dosage form), the requirements of PREA were not triggered by NDA 22272."

Summary Review for Oxycontin Pediatric sNDA:
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022272Orig1s027SumR.pdf

Like I wrote before, Pediatric Exclusivity only adds 6 months to existing exclusivities. So even if Oxycontin got it, the nasal exclusivity would be extended by 6 months and would have still expired in 2016.

WeeZuhl wrote: "pediatric exclusivity may be granted to a product without remaining exclusivity"

Oxycontin has dozens of unexpired patents and the nasal exclusivity which did not expire until 2016. So that provision does not apply since it applies only if patents are expired and FDA exclusivities are expired. And if it did apply, 3 years marketing exclusivity would be given to the "pediatric supplement" and then 6 months "pediatric exclusivity" would be added to the marketing exclusivity.

So no "PED" code means no Pediatric Exclusivity for Oxycontin. And "PED" code only adds 6 months to existing exclusivities.

WeeZuhl wrote: "what exactly do you think the NPP exclusivity through August 13, 2018 means? You said yourself you could not figure out why Rexista did not get Priority Review when all other ADF's did."

I think you already know what "NPP" means. The NPP code means Oxycontin has marketing exclusivity for the New Patient Population, which I think is from ages 11 to 17. That means no other extended-release Oxycodone can market or include labeling for ages 11 to 17. Other extended-release Oxycodone drugs can still be approved and marketed to adults. In the case of Xtampza and Troxyca, the two drugs are for use by adults and untested in pediatric population.

As for Priority Review, I said MOST other ADF's got Priority Review. I knew Pfizer's Troxyca did not get Priority Review. There might be others that did not. I just found out reason why Troxyca did not get it.

Troxyca FDA correspondence from 2014 said that there is an existing drug with abuse deterrence so Priority Review was not granted. I assume the existing drug is Oxycontin. I would assume that is similar to why IPCI's Rexista was not given Priority Review, since there are already similar drugs with ADF, such as Oxycontin, Xtampza, and Troxyca.

I think FDA should really clarify Priority Review issue, since FDA issued the statement that development of abuse-deterrent drugs are a priority for public health. Then FDA confuses NDA filers expecting Priority Review, but do not get it.