Elite Pharmaceuticals Inc (ELTP)

[Bngo]

Why does the FDA accept the delayed Tmax levels from existing oxycodone drugs and not accept SequestOx's delayed Tmax level with food?

Hope the appeal will convince the FDA to do the right thing!



The two excerpts below are from Oxycodone Immediate Release Capsules' and Roxycodone's PIs.

1. Oxycodone Immediate-Release Capsules
Food Effects
When administered with a high-fat meal mean AUC values are increased by 23% and peak concentrations are decreased by 14%. Food caused a delay in Tmax (1.00 to 3.00 hours).

2. Roxycodone
Food Effect: A single-dose food effect study was conducted in normal volunteers using the 5 mg/5 mL solution. The concurrent intake of a high fat meal was shown to enhance the extent (27% increase in AUC), but not the rate of oxycodone absorption from the oral solution (see Table 1). In addition, food caused a delay in Tmax (1.25 to 2.54 hour). Similar effects of food are expected with the 15 mg and 30 mg tablets.

If concerned with potential drug overdose because of delayed Tmax levels, then shouldn't oxycodone immediate-release capsules and Roxycodone be pull from the market right now by the FDA?

I still strongly believe that SequestOx will get approved!
GLTA!