Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Knowing Avridi was voted down 23-1 due to its Tmax delay, nasrat subsequently went ahead and filed Sequest anyway... then was shocked to receive a CRL? laughable!

Blue,

kayak wench rightly argues that with the milestone payment structure, NH would have been a fool not to file, even if he was sure of failure, because the application triggered a nonrefundable $2.5 million payment. Makes sense.

I previously conjectured that because of the detergent ADF, the Avridi tmax delay is probably substantially worse than the SequestOx tmax delay, which should act more like a standard capsule. So, for sure, NH was sweating heavily after the Avridi AdCom vote, but he may have legitimately thought there was a good chance for SequestOx to slip through, especially if the tmax delay was not as bad. I notice the date of my post was 3 months ago, but we still do not know the specific details of the SequestOx tmax delay. I also have not heard anything from the FDA about my FOIA request.





http://investorshub.advfn.com/boards/read_msg.aspx?message_id=124579915

SUMMARY

1. Original Roxicodone tablets were never tested (or at least never reported) under high-calorie fed conditions.

2. Every oxycodone tablet sold in U.S. carries a label that reports the food effect data (Tmax) of oral solution instead of tablet. It is unknown how many, if any, of the currently-marketed generic tablets were tested for bioequivalence after high-calorie meal. Many times ANDA applications are granted “in vivo waivers,” meaning their bioequivalence is assumed based on “in vitro” biochemical analysis.

3. Currently-approved oxycodone 5mg capsules have significantly slower Tmax compared with oral solution- double the Tmax effect and well-outside of the range of bioequivalence with oral solution. These capsules are not considered to have a food effect and do not carry instructions to take on an empty stomach.

4. Currently-approved oxycodone 5mg capsules have Tmax after high-cal meal of 3 hours. Bioequivalence standards require SequestOx to be within 125%, or 3 hours 45 minutes. If SequestOx fed Tmax is equal to or less than 3 hours 45 minutes, then it is already bioequivalent to Lehigh Valley NDA #200-534 and could be immediately approved in 5mg size if RLD is changed.

5. Lehigh Valley Pharmaceticals received Approval for oxycodone 5mg capsules, despite significantly delayed fed Tmax, without any food-effect labeling or safety concerns. The commentary which may explain why this was allowed has been redacted from the NDA’s Summary Review, which is signed by FDA’s Dr. Sharon Hertz. A Freedom of Information Act Request has been submitted by me for the redacted discussion.

6. While there is a significant difference in the effect of a high calorie meal on Tmax of oxycodone solution compared with capsules, there is no published data regarding the fed Tmax of tablets. In a three-way crossover pivotal BE study, it is unlikely SequestOx had any “fed control” arm with tablets. Nasrat likely has access to tablet fed Tmax data because of Elite’s work on Epic’s oxycodone tablet ANDA. This may be the kind of information he is collecting to show FDA.

7. Avridi used oxycodone tablets as a fed control, but the data is reported as “median” instead of “mean,” so it is not comparable to published data. Extrapolation suggests the mean is slower than the reported median for both Avridi and oxycodone tablets, but it was not suggestive of major Tmax difference between oxycodone tablets and solution. Based on my guesstimation, if Avridi reported fed Tmax as “mean” instead of “median”, it would look even worse, greater than 5 hours (and therefore outside the bioequivalence range of even the Lehigh Valley capsules). Avridi has detergent ADF, but SequestOx does not.